{"protocolSection":{"identificationModule":{"nctId":"NCT00385671","orgStudyIdInfo":{"id":"10822"},"secondaryIdInfos":[{"id":"F1J-US-HMEZ","type":"OTHER","domain":"Eli Lilly and Company"}],"organization":{"fullName":"Eli Lilly and Company","class":"INDUSTRY"},"briefTitle":"An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain","officialTitle":"An Open-Label, Randomized Comparison of Duloxetine, Pregabalin, and the Combination of Duloxetine and Gabapentin Among Patients With Inadequate Response to Gabapentin for the Management of Diabetic Peripheral Neuropathic Pain"},"statusModule":{"statusVerifiedDate":"2011-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2006-09"},"primaryCompletionDateStruct":{"date":"2009-08","type":"ACTUAL"},"completionDateStruct":{"date":"2009-11","type":"ACTUAL"},"studyFirstSubmitDate":"2006-10-06","studyFirstSubmitQcDate":"2006-10-06","studyFirstPostDateStruct":{"date":"2006-10-11","type":"ESTIMATED"},"resultsFirstSubmitDate":"2010-08-23","resultsFirstSubmitQcDate":"2010-10-01","resultsFirstPostDateStruct":{"date":"2010-10-18","type":"ESTIMATED"},"lastUpdateSubmitDate":"2011-07-22","lastUpdatePostDateStruct":{"date":"2011-07-26","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"oldNameTitle":"Chief Medical Officer","oldOrganization":"Eli Lilly"},"leadSponsor":{"name":"Eli Lilly and Company","class":"INDUSTRY"},"collaborators":[{"name":"Boehringer Ingelheim","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"To test the non-inferiority of duloxetine monotherapy as a treatment for the management of diabetic peripheral neuropathic pain as compared to pregabalin treatment among patients who have not had an adequate response to gabapentin."},"conditionsModule":{"conditions":["Diabetic Neuropathy, Painful"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":407,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Pregabalin","type":"ACTIVE_COMPARATOR","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks.","interventionNames":["Drug: pregabalin"]},{"label":"Duloxetine","type":"EXPERIMENTAL","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.","interventionNames":["Drug: duloxetine hydrochloride"]},{"label":"Gabapentin + Duloxetine","type":"EXPERIMENTAL","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.","interventionNames":["Drug: duloxetine hydrochloride","Drug: gabapentin"]}],"interventions":[{"type":"DRUG","name":"duloxetine hydrochloride","description":"Duloxetine (DLX) once daily (QD), orally (PO)","armGroupLabels":["Duloxetine","Gabapentin + Duloxetine"],"otherNames":["LY248686","Cymbalta"]},{"type":"DRUG","name":"pregabalin","description":"Pregabalin (PGB) orally (PO)","armGroupLabels":["Pregabalin"]},{"type":"DRUG","name":"gabapentin","description":"Stable Gabapentin (GAB) (participants will remain on the same dose of gabapentin at which they entered the study)","armGroupLabels":["Gabapentin + Duloxetine"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Pregabalin Compared With Duloxetine","description":"This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"}],"secondaryOutcomes":[{"measure":"Mean Change From Baseline to 12 Weeks in Weekly Mean of Daily 24 Hour Average Pain Score, Duloxetine Compared With Duloxetine+Gabapentin","description":"This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Weekly Mean of Nighttime Pain Severity","description":"This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily nighttime pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Weekly Mean of the Daily Worst Pain Severity Score","description":"This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily worst pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity)","description":"Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Patient's Global Impression of Improvement Scale (PGI - Improvement) at 12 Weeks","description":"A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).","timeFrame":"12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain","description":"A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Worst Pain","description":"A self-reported scale that measures the severity of pain based on the worst pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 Weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Least Pain","description":"A self-reported scale that measures the severity of pain based on the least pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: Pain Right Now","description":"A self-reported scale that measures the severity of pain based on the pain right now. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference: With General Activity","description":"A self-reported scale that measures the interference of pain in the past 24 hours on general activity. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Mood","description":"A self-reported scale that measures the interference of pain in the past 24 hours on mood. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Walking Ability","description":"A self-reported scale that measures the interference of pain in the past 24 hours on walking ability. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Normal Work","description":"A self-reported scale that measures the interference of pain in the past 24 hours on normal work. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Relations With Other People","description":"A self-reported scale that measures the interference of pain in the past 24 hours on relations with other people. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Sleep","description":"A self-reported scale that measures the interference of pain in the past 24 hours on sleep. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Interference With Enjoyment of Life","description":"A self-reported scale that measures the interference of pain in the past 24 hours on enjoyment of life. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Mean Interference Score","description":"The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Number of Participants With ≥ 30% Reduction in the Weekly Mean 24 Hour Average Pain Score at 12 Weeks","description":"This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.","timeFrame":"baseline, 12 weeks"},{"measure":"Number of Patients With a Reduction of ≥ 50% in Weekly Mean of 24 Hour Average Pain Score","description":"This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.","timeFrame":"baseline, 12 weeks"},{"measure":"Number of Participants With a ≥ 2-points Reduction on the Weekly Average of the Daily 24-hour Average Pain Scale at 12 Weeks","description":"This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.","timeFrame":"baseline, 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS)","description":"The LSEQ assesses the effects of psychoactive compounds on sleep and early morning behavior. Participants mark a series of 100 mm line analogue scales, indicating the direction and magnitude of any changes in behavioral state they experience following administration of the drug. Scores are represented in millimeters, higher scores indicate better sleep and better early morning behavior. Subscale score ranges: GTS=0-300, QOS=0-200, AFS=0-200, BFW=0-300. Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3","description":"The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30, higher values indicate greater disruption in the patient's life. Item 1 assesses the effect of the patient's symptoms on their work/school schedule, Item 2 on their social life/leisure activities, and Item 3 on their family life/home responsibilities. Subscales scores range: 0-10, higher values indicate greater disruption in the patient's life. Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Summary of Adverse Events and Serious Adverse Events Leading to Discontinuation","timeFrame":"baseline through 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores","description":"14-item subject-rated scale assessing medication related changes in sexual activity + functioning. Structured interview/questionnaire. It measures five dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; and orgasm. The total score is obtained across all 5 dimensions, ranging from 14 to 70. Subscale score ranges: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Least-squares means: adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores","description":"14-item subject-rated scale assessing changes in sexual activity and functioning; structured interview/questionnaire, designed to measure medication related changes in sexual functioning. 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Total score: obtained across all 5 dimensions, ranges from 14 to 70. Subscale scores: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Categories: better=positive change in score; same=no change in score; worse=negative change in score.","timeFrame":"baseline, 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores","description":"The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. The total score ranges from 15-135 with higher scores indicating more toxicity. The cognitive toxicity score ranges from 10-90 and the somatomotor toxicity score ranges from 5-45, for both higher scores indicate more toxicity. Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Categorial Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores","description":"The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. Categories: better=negative change in score; same=no change in score; worse=positive change in score.","timeFrame":"baseline, 12 weeks"},{"measure":"Path Analysis of Improvement in Pain Through Improvement in Depressive Symptoms","description":"Contribution to reduction in pain directly by treatment and indirectly by treatment through the reduction of depressive symptoms using path analysis. The direct treatment effect estimates the mean drug difference in pain reduction directly through treatment; the indirect treatment effect estimates the contribution that treatment plays to the mean drug difference in pain reduction indirectly through the reduction in mood symptoms; the total effect estimates the drug difference in reducing pain in sum through the specified path of direct and indirect treatment effects.","timeFrame":"baseline through 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Beck Depression Inventory II (BDI-II) Total Score","description":"A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale","description":"The Resource Utilization Scale measures direct and indirect costs (collected only for US sites). Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Inpatient costs include costs associated with hospitalizations and time spent in emergency rooms and psychiatric rooms. Outpatient costs include costs associated with visits to various health care providers, home health care by health care providers, and partial care.","timeFrame":"baseline, 12 weeks"},{"measure":"Summary of Number of Participants Who Discontinued","description":"Number of participants who discontinued. The reasons for discontinuation are presented in the participant flow.","timeFrame":"baseline through 12 weeks"},{"measure":"Time to First ≥ 30% Reduction in Weekly Mean 24 Hour Average Pain Score","description":"This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.","timeFrame":"baseline through 12 weeks"},{"measure":"Time to First ≥ 50 % Reduction in Weekly Mean 24 Hour Average Pain Score","description":"This is the number of days to first achieve ≥50% reduction, baseline to endpoint, in the weekly means of the 24-hour average pain severity via daily patient assessments using an ordinal scale (scores from 0 (no pain) to 10 (worst possible pain). The median time to first ≥50% reduction with some measure of dispersion could not be calculated for each treatment group. The number of patients who reached a ≥50% reduction in weekly mean 24 hour average pain score are presented in outcome measure 20.","timeFrame":"baseline through 12 weeks"},{"measure":"Time to First Sustained Response in Weekly Mean 24 Hour Average Pain Score","description":"This is the number of days to first achieve an outcome using the weekly means of the 24-hour average pain severity via daily patient assessments using an ordinal scale (scores from 0 (no pain) to 10 (worst possible pain). Sustained response: ≥30% reduction, baseline to endpoint, with 30% reduction from baseline ≥2 weeks prior to endpoint, remaining at ≥20% reduction between. The median time to sustained response with some measure of dispersion could not be calculated for each treatment group.","timeFrame":"baseline through 12 weeks"},{"measure":"Time to First ≥ 2 Points Reduction in Weekly Mean 24 Hour Average Pain Score","description":"This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.","timeFrame":"baseline through 12 weeks"},{"measure":"Weekly Mean Change in 24 Hour Average Pain Severity +/- Generalized Anxiety Disorder (GAD)","description":"This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries.\n\nIt was planned to analyze participants stratified by the presence or absence of a co-morbidity with GAD. However, due to the low number of participants with GAD in the study this analysis was not possible.","timeFrame":"baseline, 12 weeks"},{"measure":"Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population)","description":"Ordinal scale: 0=no pain, 10=worst possible pain. Data=weekly mean of scores of average pain severity over last 24 hours (h). Scores: daily assessments recorded by patients in diaries. Only patients adhering to key protocol criteria included: baseline Weekly Mean 24h Average Pain Score ≥4; 80-120% compliant with study Drug, each visit; baseline Michigan Neuropathy Screening Instrument Physical Assessment Total Score ≥3; gabapentin taper ≤14 days, no HbA1c ≥12% post randomization; no contraindicated medications used. Least-squares means=adjustment due to baseline severity + investigative site.","timeFrame":"baseline, 12 weeks"},{"measure":"Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use)","description":"This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. De novo: use of gabapentin for \\<56 contiguous days prior to randomization. Prior use: use of gabapentin for \\>=56 contiguous days prior to randomization. Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks"},{"measure":"Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure","description":"Presented are numbers of participants who discontinued due to a change from baseline in laboratory analytes or vital signs.","timeFrame":"baseline through 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Blood Pressure","description":"Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline through 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Heart Rate","description":"Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline through 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Body Weight","description":"Least-squares means represent adjustment due to baseline severity and investigative site.","timeFrame":"baseline through 12 weeks"},{"measure":"Number of Participants With Treatment-emergent Elevated Blood Pressure","description":"Elevated systolic blood pressure: \\>=130 millimeter mercury (mm Hg) + an increase of \\>=10 mm Hg if baseline \\<130 mm Hg.\n\nElevated diastolic blood pressure: \\>=85 mm Hg + an increase of \\>=10 mm Hg if baseline \\<85 mm Hg.","timeFrame":"baseline through 12 weeks"},{"measure":"Number of Participants With Treatment-Emergent Elevated Heart Rate","description":"Elevated heart rate: \\>=100 beats per minute (bpm) + an increase of \\>=10 bpm if baseline \\<100 bpm.","timeFrame":"baseline through 12 weeks"},{"measure":"Number of Participants With Treatment-Emergent Changes in Body Weight","description":"Treatment-emergent high body weight: weight at last visit \\>=107% of baseline weight.\n\nTreatment-emergent low body weight: weight at last visit \\<=93% of baseline weight.","timeFrame":"baseline through 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Hepatic Enzyme Serum Levels","description":"Aspartate aminotransferase = AST Alanine aminotransferase = ALT Gamma glutamyl transferase = GGT Alkaline phosphatase = AlkPhos","timeFrame":"baseline, 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Total Bilirubin","timeFrame":"baseline, 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose","timeFrame":"baseline, 12 weeks"},{"measure":"Mean Change From Baseline to 12 Weeks in Hemoglobin A1C","timeFrame":"baseline, 12 weeks"},{"measure":"Number of Patients With Treatment-Emergent Elevated Laboratory Analytes","description":"Treatment-emergent: within range at baseline, out of range after baseline. Ranges in Units/Liter (U/L). Aspartate Aminotransferase (AST): female (f): \\>34, male (m): \\>36. Alanine Aminotransferase (ALT): f:\\<69 years (yr) \\>34, ≥69yr \\>32; m: \\<69yr \\>43, ≥69yr \\>35. Total Bilirubin (TBili): \\>21. Gamma Glutamyl Transferase (GGT): f: \\<59yr \\>49, ≥59yr \\>50; m: \\<59yr \\>61, ≥59yr \\>50. Fasting Plasma Glucose (FPG): \\<59yr \\>6.4, ≥59yr \\>6.7. Hemoglobin A1C (HbA1C) \\>6%. Alkaline Phosphatase (AlkPhos): f: 18-50yr \\>106, 50-70yr \\>123, 70-80yr \\>164, ≥80yr \\>221; m: 18-50yr \\>129, 50-70yr \\>131, 70-80yr \\>156, ≥80yr \\>187","timeFrame":"baseline through 12 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* You must have been diagnosed with Diabetic Neuropathic Pain\n* Patient has an average daily pain score greater than or equal to 4 on an 11-point Likert scale, and patient or provider feel that a change from the current gabapentin therapy for pain management is warranted\n* Patient is currently treated with gabapentin greater than or equal to 900 milligram/day, has been prescribed the current dose for at least 4 weeks, and has been at least 80% compliant with dosing, according to patient report\n* Patient must agree not to change dose of gabapentin between Visits 1 and 2\n* You must have stable glycemic control\n\nExclusion Criteria:\n\n* Are judged prior to randomization to be at suicidal risk as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II)\n* Current diagnosis or history of hemangiosarcoma\n* Patients with New York Heart Association Class III or IV symptoms of congestive heart failure\n* Patients with uncontrolled narrow-angle glaucoma\n* Presence of a current seizure disorder","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)","affiliation":"Eli Lilly and Company","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Torrance","state":"California","zip":"90503","country":"United States","geoPoint":{"lat":33.83585,"lon":-118.34063}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Cromwell","state":"Connecticut","zip":"06416","country":"United States","geoPoint":{"lat":41.5951,"lon":-72.64537}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Staten Island","state":"New York","zip":"10312","country":"United States","geoPoint":{"lat":40.56233,"lon":-74.13986}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Greenville","state":"North Carolina","zip":"27834","country":"United States","geoPoint":{"lat":35.61266,"lon":-77.36635}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Midvale","state":"Utah","zip":"84047","country":"United States","geoPoint":{"lat":40.61106,"lon":-111.89994}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Bochum","zip":"D-44805","country":"Germany","geoPoint":{"lat":51.48165,"lon":7.21648}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Dresden","zip":"01307","country":"Germany","geoPoint":{"lat":51.05089,"lon":13.73832}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Hamburg","zip":"20354","country":"Germany","geoPoint":{"lat":53.55073,"lon":9.99302}},{"facility":"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.","city":"Siegen","zip":"57072","country":"Germany","geoPoint":{"lat":50.87481,"lon":8.02431}}]},"referencesModule":{"references":[{"pmid":"21719618","type":"RESULT","citation":"Tanenberg RJ, Irving GA, Risser RC, Ahl J, Robinson MJ, Skljarevski V, Malcolm SK. Duloxetine, pregabalin, and duloxetine plus gabapentin for diabetic peripheral neuropathic pain management in patients with inadequate pain response to gabapentin: an open-label, randomized, noninferiority comparison. Mayo Clin Proc. 2011 Jul;86(7):615-26. doi: 10.4065/mcp.2010.0681."},{"pmid":"24837444","type":"DERIVED","citation":"Irving G, Tanenberg RJ, Raskin J, Risser RC, Malcolm S. Comparative safety and tolerability of duloxetine vs. pregabalin vs. duloxetine plus gabapentin in patients with diabetic peripheral neuropathic pain. Int J Clin Pract. 2014 Sep;68(9):1130-40. doi: 10.1111/ijcp.12452. Epub 2014 May 18."}],"seeAlsoLinks":[{"label":"Lilly Clinical Trial Registry","url":"http://www.lillytrials.com"}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"FG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"FG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"periods":[{"title":"Overall 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Least-squares means represent adjustment due to baseline severity and investigative site.","populationDescription":"All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"baseline, 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"127"},{"groupId":"OG001","value":"120"},{"groupId":"OG002","value":"125"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.30","spread":"0.21"},{"groupId":"OG001","value":"-2.71","spread":"0.22"},{"groupId":"OG002","value":"-2.49","spread":"0.21"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.463","pValueComment":"P-values are not adjusted for multiple comparisons. 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The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean of nighttime pain severity.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.463","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 12 Weeks in Weekly Mean of the Daily Worst Pain Severity Score","description":"This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the daily worst pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. 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The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 12 Weeks in Clinical Global Impression of Severity Scale (CGI Severity)","description":"Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). 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The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"0.10","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.17","ciUpperLimit":"0.37"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in CGI severity.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.841","pValueComment":"P-values are not adjusted for multiple comparisons. 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The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Variance model and t-tests:\n\nEndpoint = InvestigatorGroup + Treatment. Last-observation-carried-forward imputation was implemented.","paramType":"Mean Difference (Final Values)","paramValue":"-0.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.53","ciUpperLimit":"0.17"}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 12 Weeks in Brief Pain Inventory (BPI) - Severity: 24-hour Average Pain","description":"A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). 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The weekly averages were based on daily assessments recorded by patients in their diaries.","populationDescription":"All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"baseline, 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"127"},{"groupId":"OG001","value":"120"},{"groupId":"OG002","value":"125"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"59"},{"groupId":"OG001","value":"64"},{"groupId":"OG002","value":"68"}]}]}],"analyses":[{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.905","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Mantel Haenszel","statisticalComment":"Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.368","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Mantel Haenszel","statisticalComment":"Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of Participants with a ≥ 2-points reduction on the weekly average of the daily 24-hour average pain scale at 12 Weeks.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.200","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Mantel Haenszel","statisticalComment":"Treatments were compared with stratification defined by InvestigatorGroup. Last-observation-carried-forward imputation was implemented.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 12 Weeks in Leeds Sleep Evaluation Questionnaire (LSEQ) Subscales of Ease of Going to Sleep (GTS), Awakening (AFS), and Behavior Following Wakefulness (BFW), Quality of Sleep (QOS)","description":"The LSEQ assesses the effects of psychoactive compounds on sleep and early morning behavior. Participants mark a series of 100 mm line analogue scales, indicating the direction and magnitude of any changes in behavioral state they experience following administration of the drug. Scores are represented in millimeters, higher scores indicate better sleep and better early morning behavior. Subscale score ranges: GTS=0-300, QOS=0-200, AFS=0-200, BFW=0-300. Least-squares means represent adjustment due to baseline severity and investigative site.","populationDescription":"All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"baseline, 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"124"},{"groupId":"OG001","value":"119"},{"groupId":"OG002","value":"118"}]}],"classes":[{"title":"GTS, n=122, n=119, n=118","categories":[{"measurements":[{"groupId":"OG000","value":"10.96","spread":"4.83"},{"groupId":"OG001","value":"17.40","spread":"5.06"},{"groupId":"OG002","value":"14.75","spread":"4.92"}]}]},{"title":"QOS, n=121, n=118, n=118","categories":[{"measurements":[{"groupId":"OG000","value":"9.32","spread":"4.01"},{"groupId":"OG001","value":"7.39","spread":"4.24"},{"groupId":"OG002","value":"9.64","spread":"4.06"}]}]},{"title":"AFS, n=122, n=118, n=118","categories":[{"measurements":[{"groupId":"OG000","value":"10.02","spread":"3.71"},{"groupId":"OG001","value":"8.14","spread":"3.92"},{"groupId":"OG002","value":"11.86","spread":"3.73"}]}]},{"title":"BFW, n=124, n=115, n=118","categories":[{"measurements":[{"groupId":"OG000","value":"19.67","spread":"5.65"},{"groupId":"OG001","value":"21.04","spread":"6.03"},{"groupId":"OG002","value":"14.33","spread":"5.77"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ GTS scores.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.572","pValueComment":"P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 weeks in LSEQ GTS scores.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.345","pValueComment":"P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ GTS scores.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.699","pValueComment":"P-value is for GTS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS scores.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.954","pValueComment":"P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS scores.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.734","pValueComment":"P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ QOS.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.693","pValueComment":"P-value is for QOS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.720","pValueComment":"P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.722","pValueComment":"P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ AFS scores.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.480","pValueComment":"P-value is for AFS. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.498","pValueComment":"P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.865","pValueComment":"P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in LSEQ BFW scores.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.408","pValueComment":"P-value is for BFW. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 12 Weeks in Sheehan Disability Scale (SDS) - Total Score and Scores for Items 1 to 3","description":"The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30, higher values indicate greater disruption in the patient's life. Item 1 assesses the effect of the patient's symptoms on their work/school schedule, Item 2 on their social life/leisure activities, and Item 3 on their family life/home responsibilities. Subscales scores range: 0-10, higher values indicate greater disruption in the patient's life. Least-squares means represent adjustment due to baseline severity and investigative site.","populationDescription":"All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"baseline, 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"118"},{"groupId":"OG001","value":"124"},{"groupId":"OG002","value":"119"}]}],"classes":[{"title":"Total","categories":[{"measurements":[{"groupId":"OG000","value":"-4.96","spread":"0.66"},{"groupId":"OG001","value":"-3.47","spread":"0.65"},{"groupId":"OG002","value":"-4.54","spread":"0.66"}]}]},{"title":"Item 1","categories":[{"measurements":[{"groupId":"OG000","value":"-1.96","spread":"0.31"},{"groupId":"OG001","value":"-1.21","spread":"0.33"},{"groupId":"OG002","value":"-1.95","spread":"0.32"}]}]},{"title":"Item 2","categories":[{"measurements":[{"groupId":"OG000","value":"-1.64","spread":"0.24"},{"groupId":"OG001","value":"-1.12","spread":"0.23"},{"groupId":"OG002","value":"-1.53","spread":"0.24"}]}]},{"title":"Item 3","categories":[{"measurements":[{"groupId":"OG000","value":"-1.70","spread":"0.22"},{"groupId":"OG001","value":"-1.17","spread":"0.22"},{"groupId":"OG002","value":"-1.54","spread":"0.22"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS total score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.635","pValueComment":"P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.42","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.18","ciUpperLimit":"1.33"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS total score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.092","pValueComment":"P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-1.50","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-3.24","ciUpperLimit":"0.24"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS total score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.221","pValueComment":"P-value is for total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-1.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.80","ciUpperLimit":"0.65"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.974","pValueComment":"P-value is for item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.88","ciUpperLimit":"0.85"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.093","pValueComment":"P-value is for Item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.75","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.63","ciUpperLimit":"0.13"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 1 score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.091","pValueComment":"P-value is for item 1. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.74","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.59","ciUpperLimit":"0.12"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS Item 2 score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.733","pValueComment":"P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.75","ciUpperLimit":"0.52"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS item 2 score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.102","pValueComment":"P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.52","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.15","ciUpperLimit":"0.11"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 2 score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.193","pValueComment":"P-value is for item 2. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.41","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.04","ciUpperLimit":"0.21"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.584","pValueComment":"P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.17","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.76","ciUpperLimit":"0.43"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.077","pValueComment":"P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.53","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.12","ciUpperLimit":"0.06"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in SDS item 3 score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.221","pValueComment":"P-value is for item 3. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. 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Consciousness","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Lymphoma","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Mental Impairment","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"Muscular Weakness","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Myoclonus","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"Pollakiuria","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Pulomnary 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The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"0.81","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.27","ciUpperLimit":"2.88"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) total score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.682","pValueComment":"P-value is for female, total. P-values are not adjusted for multiple comparisons. 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The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.36","ciUpperLimit":"0.26"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.390","pValueComment":"P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"0.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.18","ciUpperLimit":"0.45"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.228","pValueComment":"P-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"0.19","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.12","ciUpperLimit":"0.49"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.260","pValueComment":"P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"0.24","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.18","ciUpperLimit":"0.67"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) pleasure subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.141","pValueComment":"P-value is for female, pleasure. P-values are not adjusted for multiple comparisons. 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The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.57","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.98","ciUpperLimit":"-0.16"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.409","pValueComment":"P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.61","ciUpperLimit":"0.25"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.715","pValueComment":"P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.51","ciUpperLimit":"0.35"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.641","pValueComment":"P-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"0.10","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.32","ciUpperLimit":"0.52"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.767","pValueComment":"P-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.64","ciUpperLimit":"0.47"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.881","pValueComment":"P-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.61","ciUpperLimit":"0.52"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/frequency subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.885","pValueComment":"p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"0.04","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.51","ciUpperLimit":"0.59"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.325","pValueComment":"P-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.32","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.96","ciUpperLimit":"0.32"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.798","pValueComment":"P-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.73","ciUpperLimit":"0.56"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.461","pValueComment":"p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"0.24","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.39","ciUpperLimit":"0.87"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.670","pValueComment":"p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.02","ciUpperLimit":"0.66"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.243","pValueComment":"P-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.51","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.37","ciUpperLimit":"0.35"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) desire/interest subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.423","pValueComment":"P-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.14","ciUpperLimit":"0.48"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.333","pValueComment":"P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.34","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.04","ciUpperLimit":"0.35"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.334","pValueComment":"P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.35","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.05","ciUpperLimit":"0.36"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.990","pValueComment":"P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.69","ciUpperLimit":"0.68"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.665","pValueComment":"P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"0.20","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.70","ciUpperLimit":"1.09"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.700","pValueComment":"P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.10","ciUpperLimit":"0.74"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) arousal subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.386","pValueComment":"P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.38","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.23","ciUpperLimit":"0.48"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.120","pValueComment":"P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.56","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.27","ciUpperLimit":"0.15"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.119","pValueComment":"P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.57","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.29","ciUpperLimit":"0.15"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in male participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.976","pValueComment":"P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.71","ciUpperLimit":"0.69"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.026","pValueComment":"P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"1.17","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.14","ciUpperLimit":"2.20"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.497","pValueComment":"P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"0.36","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.69","ciUpperLimit":"1.42"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in female participants in mean change from baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) orgasm subscore.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.112","pValueComment":"P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Covariance model and t-tests:\n\nChange=InvestigatorGroup+Baseline+Treatment. Last-observation-carried-forward imputation was used.","paramType":"Mean Difference (Final Values)","paramValue":"-0.80","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.80","ciUpperLimit":"0.19"}]},{"type":"SECONDARY","title":"Categorical Change From Baseline to 12 Weeks in Sexual Functioning Questionnaire (CSFQ) Total Score and Subscale Scores","description":"14-item subject-rated scale assessing changes in sexual activity and functioning; structured interview/questionnaire, designed to measure medication related changes in sexual functioning. 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Total score: obtained across all 5 dimensions, ranges from 14 to 70. Subscale scores: desire/frequency=2-10; desire/interest=3-15; pleasure=1-5; arousal=3-15; orgasm=3-15. Higher scores = better sexual functioning. Categories: better=positive change in score; same=no change in score; worse=negative change in score.","populationDescription":"All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"baseline, 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"138"},{"groupId":"OG002","value":"135"}]}],"classes":[{"title":"male, total, better; n=62, n=67, n=66","categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"26"},{"groupId":"OG002","value":"31"}]}]},{"title":"male, total, same; n=62, n=67, n=66","categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"11"}]}]},{"title":"male, total, worse; n=62, n=67, n=66","categories":[{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"32"},{"groupId":"OG002","value":"24"}]}]},{"title":"female, total, better; n=39, n=42, n=43","categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"23"},{"groupId":"OG002","value":"18"}]}]},{"title":"female, total, same; n=39, n=42, n=43","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"7"}]}]},{"title":"female, total, worse; n=39, n=42, n=43","categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"18"}]}]},{"title":"male, pleasure, better; n=64, n=67, n=69","categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"21"}]}]},{"title":"male, pleasure, same; n=64, n=67, n=69","categories":[{"measurements":[{"groupId":"OG000","value":"39"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"32"}]}]},{"title":"male, pleasure, worse; n=64, n=67, n=69","categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"16"}]}]},{"title":"female, pleasure, better; n=40, n=42, n=43","categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"6"}]}]},{"title":"female, pleasure, same; n=40, n=42, n=43","categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"32"}]}]},{"title":"female, pleasure, worse; n=40, n=42, n=43","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"5"}]}]},{"title":"male, desire/frequency, better; n=65, n=67, n=69","categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"24"}]}]},{"title":"male, desire/frequency, same; n=65, n=67, n=69","categories":[{"measurements":[{"groupId":"OG000","value":"36"},{"groupId":"OG001","value":"29"},{"groupId":"OG002","value":"23"}]}]},{"title":"male, desire/frequency, worse; n=65, n=67, n=69","categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"22"}]}]},{"title":"female, desire/frequency, better; n=42, n=42, n=43","categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"12"}]}]},{"title":"female, desire/frequency, same; n=42, n=42, n=43","categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"21"},{"groupId":"OG002","value":"24"}]}]},{"title":"female, desire/frequency, worse; n=42, n=42, n=43","categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"7"}]}]},{"title":"male, desire/interest, better; n=65, n=67, n=70","categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"26"}]}]},{"title":"male, desire/interest, same; n=65, n=67, n=70","categories":[{"measurements":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"19"},{"groupId":"OG002","value":"17"}]}]},{"title":"male, desire/interest, worse; n=65, n=67, n=70","categories":[{"measurements":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"30"},{"groupId":"OG002","value":"27"}]}]},{"title":"female, desire/interest, better; n=42, n=42, n=45","categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"16"}]}]},{"title":"female, desire/interest, same; n=42, n=42, n=45","categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"17"}]}]},{"title":"female, desire/interest, worse; n=42, n=42, n=45","categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"12"}]}]},{"title":"male, arousal, better; n=65, n=67, n=70","categories":[{"measurements":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"24"},{"groupId":"OG002","value":"23"}]}]},{"title":"male, arousal, same; n=65, n=67, n=70","categories":[{"measurements":[{"groupId":"OG000","value":"28"},{"groupId":"OG001","value":"29"},{"groupId":"OG002","value":"33"}]}]},{"title":"male, arousal, worse; n=65, n=67, n=70","categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"14"}]}]},{"title":"female, arousal, better; n=40, n=42, n=45","categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"15"}]}]},{"title":"female, arousal, same; n=40, n=42, n=45","categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"16"}]}]},{"title":"female, arousal, worse; n=40, n=42, n=45","categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"14"},{"groupId":"OG002","value":"14"}]}]},{"title":"male, orgasm, better; n=64, n=67, n=69","categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"17"}]}]},{"title":"male, orgasm, same; n=64, n=67, n=69","categories":[{"measurements":[{"groupId":"OG000","value":"29"},{"groupId":"OG001","value":"31"},{"groupId":"OG002","value":"29"}]}]},{"title":"male, orgasm, worse; n=64, n=67, n=69","categories":[{"measurements":[{"groupId":"OG000","value":"23"},{"groupId":"OG001","value":"18"},{"groupId":"OG002","value":"23"}]}]},{"title":"female, orgasm, better; n=40, n=42, n=43","categories":[{"measurements":[{"groupId":"OG000","value":"15"},{"groupId":"OG001","value":"17"},{"groupId":"OG002","value":"11"}]}]},{"title":"female, orgasm, same; n=40, n=42, n=43","categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"13"},{"groupId":"OG002","value":"16"}]}]},{"title":"female, orgasm, worse; n=40, n=42, n=43","categories":[{"measurements":[{"groupId":"OG000","value":"12"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"16"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.486","pValueComment":"P-value is for male, total. 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The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.411","pValueComment":"p-value is for male, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.554","pValueComment":"p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.128","pValueComment":"p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in total score from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.488","pValueComment":"p-value is for female, total. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.226","pValueComment":"p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. 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The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.133","pValueComment":"p-value is for male, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.257","pValueComment":"p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.412","pValueComment":"p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in pleasure subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.030","pValueComment":"p-value is for female, pleasure. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.024","pValueComment":"p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.250","pValueComment":"p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.489","pValueComment":"p-value is for male, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.682","pValueComment":"p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.953","pValueComment":"p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in desire/frequency subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.803","pValueComment":"p-value is for female, desire/frequency. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.694","pValueComment":"p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.835","pValueComment":"p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.435","pValueComment":"p-value is for male, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.379","pValueComment":"p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.247","pValueComment":"p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in desire/interest subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.784","pValueComment":"p-value is for female, desire/interest. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.696","pValueComment":"p-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.725","pValueComment":"P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.899","pValueComment":"P-value is for male, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.782","pValueComment":"P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.307","pValueComment":"P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in arousal subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.457","pValueComment":"P-value is for female, arousal. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.712","pValueComment":"P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.403","pValueComment":"P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of male participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.713","pValueComment":"P-value is for male, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.498","pValueComment":"P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.963","pValueComment":"P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of female participants with a categorical change in orgasm subscore from baseline to 12 weeks in the Sexual Functioning Questionnaire (CSFQ).","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.338","pValueComment":"P-value is for female, orgasm. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Chi-squared","statisticalComment":"Pairwise p-values come from the Likelihood-Ratio Chi-squared test.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 12 Weeks in Portland Neurotoxicity Scale - Total Score and Subscale Scores","description":"The Portland Neurotoxicity Scale is a 15-item, patient-completed questionnaire designed to assess the degree of impact of anti-epileptic drug therapy on a number of cognitive and somatomotor parameters. The total score ranges from 15-135 with higher scores indicating more toxicity. The cognitive toxicity score ranges from 10-90 and the somatomotor toxicity score ranges from 5-45, for both higher scores indicate more toxicity. 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The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Total Score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.470","pValueComment":"P-value is for total. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.914","pValueComment":"P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Cognitive Toxicity Score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.505","pValueComment":"P-value is for cognitive toxicity. P-values are not adjusted for multiple comparisons. 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The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Portland Neurotoxicity Scale Somatomotor Toxicity Score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.430","pValueComment":"P-value is for somatomotor toxicity. P-values are not adjusted for multiple comparisons. 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The direct treatment effect estimates the mean drug difference in pain reduction directly through treatment; the indirect treatment effect estimates the contribution that treatment plays to the mean drug difference in pain reduction indirectly through the reduction in mood symptoms; the total effect estimates the drug difference in reducing pain in sum through the specified path of direct and indirect treatment effects.","populationDescription":"All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"coefficient","timeFrame":"baseline through 12 weeks","groups":[{"id":"OG000","title":"Ordinary Coefficient","description":"Beta-coefficient from regression analyses estimating direct and indirect treatment effects expressed in the observed scale of measurement of the dependent variable."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"234"}]}],"classes":[{"title":"Direct Treatment Effect","categories":[{"measurements":[{"groupId":"OG000","value":"-0.449"}]}]},{"title":"Indirect Treatment Effect","categories":[{"measurements":[{"groupId":"OG000","value":"0.014"}]}]},{"title":"Total Treatment Effect","categories":[{"measurements":[{"groupId":"OG000","value":"-0.435"}]}]}],"analyses":[{"groupIds":["OG000"],"testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.107","pValueComment":"P-value for Direct Treatment Effect. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for tests of direct and indirect effects.","statisticalMethod":"Regression, Linear","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 12 Weeks in Beck Depression Inventory II (BDI-II) Total Score","description":"A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. Least-squares means represent adjustment due to baseline severity and investigative site.","populationDescription":"All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"baseline, 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"125"},{"groupId":"OG002","value":"125"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.57","spread":"0.58"},{"groupId":"OG001","value":"-3.13","spread":"0.60"},{"groupId":"OG002","value":"-2.54","spread":"0.57"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.968","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.492","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in BDI-II total score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.463","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Categorical Change From Baseline to 12 Weeks in Number of Patients Using Health Care as Measured by the Resource Utilization Scale","description":"The Resource Utilization Scale measures direct and indirect costs (collected only for US sites). Direct costs include inpatient and outpatient costs, while indirect costs include lost days of work and caregiver time spent with patients. Inpatient costs include costs associated with hospitalizations and time spent in emergency rooms and psychiatric rooms. Outpatient costs include costs associated with visits to various health care providers, home health care by health care providers, and partial care.","populationDescription":"All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"baseline, 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"138"},{"groupId":"OG002","value":"135"}]}],"classes":[{"title":"hours worked, greater, n=86, n=90, n=83","categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"13"}]}]},{"title":"hours worked, same, n=86, n=90, n=83","categories":[{"measurements":[{"groupId":"OG000","value":"65"},{"groupId":"OG001","value":"66"},{"groupId":"OG002","value":"59"}]}]},{"title":"hours worked, lower, n=86, n=90, n=83","categories":[{"measurements":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"11"}]}]},{"title":"hours volunteered, greater, n=86, n=91, n=82","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"10"}]}]},{"title":"hours volunteered, same, n=86, n=91, n=82","categories":[{"measurements":[{"groupId":"OG000","value":"66"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"66"}]}]},{"title":"hours volunteered, lower, n=86, n=91, n=82","categories":[{"measurements":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"}]}]},{"title":"psychiatric visits, greater, n=92, n=93, n=90","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"}]}]},{"title":"psychiatric visits, same, n=92, n=93, n=90","categories":[{"measurements":[{"groupId":"OG000","value":"88"},{"groupId":"OG001","value":"91"},{"groupId":"OG002","value":"84"}]}]},{"title":"psychiatric visits, lower, n=92, n=93, n=90","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"4"}]}]},{"title":"outpatient group visits, greater, n=91, n=92, n=91","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"outpatient group visits, same, n=91, n=92, n=91","categories":[{"measurements":[{"groupId":"OG000","value":"90"},{"groupId":"OG001","value":"92"},{"groupId":"OG002","value":"89"}]}]},{"title":"outpatient group visits, lower, n=91, n=92, n=91","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"outpatient ind. visits, greater, n=91, n=88, n=90","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"4"}]}]},{"title":"outpatient ind. visits, same, n=91, n=88, n=90","categories":[{"measurements":[{"groupId":"OG000","value":"84"},{"groupId":"OG001","value":"84"},{"groupId":"OG002","value":"81"}]}]},{"title":"outpatient ind. visits, lower, n=91, n=88, n=90","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"5"}]}]},{"title":"days of partial care, greater, n=93, n=95, n=90","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"}]}]},{"title":"days of partial care, same, n=93, n=95, n=90","categories":[{"measurements":[{"groupId":"OG000","value":"91"},{"groupId":"OG001","value":"94"},{"groupId":"OG002","value":"87"}]}]},{"title":"days of partial care, lower, n=93, n=95, n=90","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"nights of partial care, greater, n=92, n=95, 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n=90","categories":[{"measurements":[{"groupId":"OG000","value":"92"},{"groupId":"OG001","value":"93"},{"groupId":"OG002","value":"87"}]}]},{"title":"phone mental health, lower,n=94, n=95, n=90","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"}]}]},{"title":"nonpsychiatric visits, greater, n=89, n=94, n=83","categories":[{"measurements":[{"groupId":"OG000","value":"24"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"18"}]}]},{"title":"nonpsychiatric visits, same, n=89, n=94, n=83","categories":[{"measurements":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"46"},{"groupId":"OG002","value":"45"}]}]},{"title":"nonpsychiatric visits, lower, n=89, n=94, n=83","categories":[{"measurements":[{"groupId":"OG000","value":"21"},{"groupId":"OG001","value":"28"},{"groupId":"OG002","value":"20"}]}]},{"title":"unpaid care, greater, n=84, n=87, n=86","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"unpaid care, same, n=84, n=87, n=86","categories":[{"measurements":[{"groupId":"OG000","value":"82"},{"groupId":"OG001","value":"87"},{"groupId":"OG002","value":"85"}]}]},{"title":"unpaid care, lower, n=84, n=87, n=86","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"missed work caregiver, greater, n=6, n=9, n=5","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"missed work caregiver, same, n=6, n=9, n=5","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"5"}]}]},{"title":"missed work caregiver, lower, n=6, n=9, n=5","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"}]}]},{"title":"paid care, greater, n=60, n=58, n=58","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"paid care, same, n=60, n=58, n=58","categories":[{"measurements":[{"groupId":"OG000","value":"60"},{"groupId":"OG001","value":"58"},{"groupId":"OG002","value":"58"}]}]},{"title":"paid care, less, n=60, n=58, n=58","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Summary of Number of Participants Who Discontinued","description":"Number of participants who discontinued. The reasons for discontinuation are presented in the participant flow.","populationDescription":"All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"baseline through 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"138"},{"groupId":"OG002","value":"135"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"51"},{"groupId":"OG002","value":"36"}]}]}]},{"type":"SECONDARY","title":"Time to First ≥ 30% Reduction in Weekly Mean 24 Hour Average Pain Score","description":"This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.","populationDescription":"All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"days","timeFrame":"baseline through 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"127"},{"groupId":"OG001","value":"120"},{"groupId":"OG002","value":"125"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"35.0","lowerLimit":"28.0","upperLimit":"55.0"},{"groupId":"OG001","value":"28.0","lowerLimit":"20.0","upperLimit":"35.0"},{"groupId":"OG002","value":"28.0","lowerLimit":"21.0","upperLimit":"35.0"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.103","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Log Rank","statisticalComment":"Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.167","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Log Rank","statisticalComment":"Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in time to first ≥ 30% reduction in weekly mean 24 hour average pain score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.919","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Log Rank","statisticalComment":"Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Time to First ≥ 50 % Reduction in Weekly Mean 24 Hour Average Pain Score","description":"This is the number of days to first achieve ≥50% reduction, baseline to endpoint, in the weekly means of the 24-hour average pain severity via daily patient assessments using an ordinal scale (scores from 0 (no pain) to 10 (worst possible pain). The median time to first ≥50% reduction with some measure of dispersion could not be calculated for each treatment group. The number of patients who reached a ≥50% reduction in weekly mean 24 hour average pain score are presented in outcome measure 20.","populationDescription":"All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"days","timeFrame":"baseline through 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"Time to First Sustained Response in Weekly Mean 24 Hour Average Pain Score","description":"This is the number of days to first achieve an outcome using the weekly means of the 24-hour average pain severity via daily patient assessments using an ordinal scale (scores from 0 (no pain) to 10 (worst possible pain). Sustained response: ≥30% reduction, baseline to endpoint, with 30% reduction from baseline ≥2 weeks prior to endpoint, remaining at ≥20% reduction between. The median time to sustained response with some measure of dispersion could not be calculated for each treatment group.","populationDescription":"All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"days","timeFrame":"baseline through 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"Time to First ≥ 2 Points Reduction in Weekly Mean 24 Hour Average Pain Score","description":"This is the number of days required to first achieve a nominal outcome reflecting whether or not a clinically-important efficacy outcome was achieved. It is based on a comparison between baseline and post-baseline scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by patients in their diaries.","populationDescription":"All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"days","timeFrame":"baseline through 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"127"},{"groupId":"OG001","value":"120"},{"groupId":"OG002","value":"125"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"56.0","lowerLimit":"39.0","upperLimit":"80.0"},{"groupId":"OG001","value":"35.0","lowerLimit":"28.0","upperLimit":"53.0"},{"groupId":"OG002","value":"28.0","lowerLimit":"22.0","upperLimit":"42.0"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.008","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Log Rank","statisticalComment":"Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.033","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Log Rank","statisticalComment":"Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in time to first ≥ 2 points reduction in weekly mean 24 hour average pain score.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.688","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Log Rank","statisticalComment":"Pairwise p-values come from the log-rank test comparing treatment-specific time-to-event curves constructed using the Kaplan-Meier technique.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Weekly Mean Change in 24 Hour Average Pain Severity +/- Generalized Anxiety Disorder (GAD)","description":"This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries.\n\nIt was planned to analyze participants stratified by the presence or absence of a co-morbidity with GAD. However, due to the low number of participants with GAD in the study this analysis was not possible.","populationDescription":"All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"baseline, 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"type":"SECONDARY","title":"Weekly Mean Change From Baseline to 12 Weeks in 24 Hour Average Pain Severity - Only Participants Who Adhered to Key Protocol Requirements (Per-Protocol Population)","description":"Ordinal scale: 0=no pain, 10=worst possible pain. Data=weekly mean of scores of average pain severity over last 24 hours (h). Scores: daily assessments recorded by patients in diaries. Only patients adhering to key protocol criteria included: baseline Weekly Mean 24h Average Pain Score ≥4; 80-120% compliant with study Drug, each visit; baseline Michigan Neuropathy Screening Instrument Physical Assessment Total Score ≥3; gabapentin taper ≤14 days, no HbA1c ≥12% post randomization; no contraindicated medications used. Least-squares means=adjustment due to baseline severity + investigative site.","populationDescription":"The per-protocol sub-population of all randomized participants with a baseline value and \\>= 1 non-missing post-baseline value (modified intent-to-treat population) was included in the analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"baseline, 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"94"},{"groupId":"OG001","value":"77"},{"groupId":"OG002","value":"103"}]}],"classes":[{"title":"baseline","categories":[{"measurements":[{"groupId":"OG000","value":"5.74","spread":"1.30"},{"groupId":"OG001","value":"6.02","spread":"1.60"},{"groupId":"OG002","value":"5.74","spread":"1.42"}]}]},{"title":"change","categories":[{"measurements":[{"groupId":"OG000","value":"-2.12","spread":"0.23"},{"groupId":"OG001","value":"-2.58","spread":"0.27"},{"groupId":"OG002","value":"-2.40","spread":"0.23"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.365","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week with participant is as a random effect, Kenward-Roger approximation.","paramType":"Mean Difference (Final Values)","paramValue":"0.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.33","ciUpperLimit":"0.90"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.172","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week with participant is as a random effect, Kenward-Roger approximation.","paramType":"Mean Difference (Final Values)","paramValue":"0.46","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.20","ciUpperLimit":"1.13"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in Weekly mean change from baseline to 12 weeks in 24 hour average pain severity score when analyzing only treatment-compliant participants.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.594","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week with participant is as a random effect, Kenward-Roger approximation.","paramType":"Mean Difference (Final Values)","paramValue":"0.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.49","ciUpperLimit":"0.85"}]},{"type":"SECONDARY","title":"Weekly Mean Change in 24 Hour Average Pain Severity by Week by Gabapentin Exposure Subgroup (de Novo Versus Prior Use)","description":"This is an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Data presented represent the weekly mean of the scores of the average pain severity over the last 24 hours. Scores are based on daily assessments recorded by patients in their diaries. De novo: use of gabapentin for \\<56 contiguous days prior to randomization. Prior use: use of gabapentin for \\>=56 contiguous days prior to randomization. Least-squares means represent adjustment due to baseline severity and investigative site.","populationDescription":"Analyzed were all participants with a baseline and at least 1 non-missing post-baseline value. Last observation carried forward analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"units on a scale","timeFrame":"baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks, 10 weeks, 11 weeks, 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"138"},{"groupId":"OG002","value":"135"}]}],"classes":[{"title":"de novo, baseline","categories":[{"measurements":[{"groupId":"OG000","value":"5.24","spread":"1.07"},{"groupId":"OG001","value":"5.39","spread":"1.48"},{"groupId":"OG002","value":"5.49","spread":"1.45"}]}]},{"title":"de novo, week 1","categories":[{"measurements":[{"groupId":"OG000","value":"-0.22","spread":"0.24"},{"groupId":"OG001","value":"-0.71","spread":"0.27"},{"groupId":"OG002","value":"-0.38","spread":"0.25"}]}]},{"title":"de novo, week 2","categories":[{"measurements":[{"groupId":"OG000","value":"-0.39","spread":"0.27"},{"groupId":"OG001","value":"-1.22","spread":"0.31"},{"groupId":"OG002","value":"-1.10","spread":"0.28"}]}]},{"title":"de novo, week 3","categories":[{"measurements":[{"groupId":"OG000","value":"-0.71","spread":"0.30"},{"groupId":"OG001","value":"-1.83","spread":"0.30"},{"groupId":"OG002","value":"-1.62","spread":"0.30"}]}]},{"title":"de novo, week 4","categories":[{"measurements":[{"groupId":"OG000","value":"-0.84","spread":"0.32"},{"groupId":"OG001","value":"-2.35","spread":"0.35"},{"groupId":"OG002","value":"-1.67","spread":"0.32"}]}]},{"title":"de novo, week 5","categories":[{"measurements":[{"groupId":"OG000","value":"-0.95","spread":"0.33"},{"groupId":"OG001","value":"-2.65","spread":"0.37"},{"groupId":"OG002","value":"-1.81","spread":"0.33"}]}]},{"title":"de novo, week 6","categories":[{"measurements":[{"groupId":"OG000","value":"-1.09","spread":"0.34"},{"groupId":"OG001","value":"-2.64","spread":"0.38"},{"groupId":"OG002","value":"-1.88","spread":"0.34"}]}]},{"title":"de novo, week 7","categories":[{"measurements":[{"groupId":"OG000","value":"-1.08","spread":"0.34"},{"groupId":"OG001","value":"-2.73","spread":"0.38"},{"groupId":"OG002","value":"-2.07","spread":"0.34"}]}]},{"title":"de novo, week 8","categories":[{"measurements":[{"groupId":"OG000","value":"-1.26","spread":"0.35"},{"groupId":"OG001","value":"-2.78","spread":"0.39"},{"groupId":"OG002","value":"-2.06","spread":"0.35"}]}]},{"title":"de novo, week 9","categories":[{"measurements":[{"groupId":"OG000","value":"-1.21","spread":"0.34"},{"groupId":"OG001","value":"-2.89","spread":"0.38"},{"groupId":"OG002","value":"-2.10","spread":"0.35"}]}]},{"title":"de novo, week 10","categories":[{"measurements":[{"groupId":"OG000","value":"-1.42","spread":"0.35"},{"groupId":"OG001","value":"-2.86","spread":"0.39"},{"groupId":"OG002","value":"-1.92","spread":"0.35"}]}]},{"title":"de novo, week 11","categories":[{"measurements":[{"groupId":"OG000","value":"-1.48","spread":"0.35"},{"groupId":"OG001","value":"-2.98","spread":"0.39"},{"groupId":"OG002","value":"-2.09","spread":"0.35"}]}]},{"title":"de novo, week 12","categories":[{"measurements":[{"groupId":"OG000","value":"-1.62","spread":"0.36"},{"groupId":"OG001","value":"-3.08","spread":"0.40"},{"groupId":"OG002","value":"-2.10","spread":"0.36"}]}]},{"title":"prior use, baseline","categories":[{"measurements":[{"groupId":"OG000","value":"5.91","spread":"1.55"},{"groupId":"OG001","value":"5.99","spread":"1.52"},{"groupId":"OG002","value":"5.92","spread":"1.48"}]}]},{"title":"prior use, week 1","categories":[{"measurements":[{"groupId":"OG000","value":"-0.30","spread":"0.17"},{"groupId":"OG001","value":"-0.48","spread":"0.16"},{"groupId":"OG002","value":"-0.65","spread":"0.17"}]}]},{"title":"prior use, week 2","categories":[{"measurements":[{"groupId":"OG000","value":"-0.70","spread":"0.19"},{"groupId":"OG001","value":"-0.99","spread":"0.19"},{"groupId":"OG002","value":"-1.28","spread":"0.19"}]}]},{"title":"prior use, week 3","categories":[{"measurements":[{"groupId":"OG000","value":"-1.18","spread":"0.20"},{"groupId":"OG001","value":"-1.32","spread":"0.20"},{"groupId":"OG002","value":"-1.68","spread":"0.21"}]}]},{"title":"prior use, week 4","categories":[{"measurements":[{"groupId":"OG000","value":"-1.64","spread":"0.21"},{"groupId":"OG001","value":"-1.61","spread":"0.22"},{"groupId":"OG002","value":"-1.75","spread":"0.22"}]}]},{"title":"prior use, week 5","categories":[{"measurements":[{"groupId":"OG000","value":"-1.72","spread":"0.22"},{"groupId":"OG001","value":"-1.95","spread":"0.23"},{"groupId":"OG002","value":"-1.96","spread":"0.22"}]}]},{"title":"prior use, week 6","categories":[{"measurements":[{"groupId":"OG000","value":"-1.92","spread":"0.23"},{"groupId":"OG001","value":"-2.03","spread":"0.23"},{"groupId":"OG002","value":"-1.98","spread":"0.23"}]}]},{"title":"prior use, week 7","categories":[{"measurements":[{"groupId":"OG000","value":"-1.93","spread":"0.23"},{"groupId":"OG001","value":"-2.14","spread":"0.23"},{"groupId":"OG002","value":"-2.17","spread":"0.23"}]}]},{"title":"prior use, week 8","categories":[{"measurements":[{"groupId":"OG000","value":"-1.89","spread":"0.23"},{"groupId":"OG001","value":"-2.16","spread":"0.24"},{"groupId":"OG002","value":"-2.31","spread":"0.23"}]}]},{"title":"prior use, week 9","categories":[{"measurements":[{"groupId":"OG000","value":"-2.04","spread":"0.23"},{"groupId":"OG001","value":"-2.38","spread":"0.24"},{"groupId":"OG002","value":"-2.37","spread":"0.23"}]}]},{"title":"prior use, week 10","categories":[{"measurements":[{"groupId":"OG000","value":"-2.14","spread":"0.23"},{"groupId":"OG001","value":"-2.45","spread":"0.24"},{"groupId":"OG002","value":"-2.44","spread":"0.24"}]}]},{"title":"prior use, week 11","categories":[{"measurements":[{"groupId":"OG000","value":"-2.27","spread":"0.23"},{"groupId":"OG001","value":"-2.46","spread":"0.24"},{"groupId":"OG002","value":"-2.41","spread":"0.24"}]}]},{"title":"prior use, week 12","categories":[{"measurements":[{"groupId":"OG000","value":"-2.39","spread":"0.23"},{"groupId":"OG001","value":"-2.46","spread":"0.24"},{"groupId":"OG002","value":"-2.53","spread":"0.24"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.622","pValueComment":"P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.16","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.48","ciUpperLimit":"0.80"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.153","pValueComment":"P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.49","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.18","ciUpperLimit":"1.16"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.344","pValueComment":"P-value is for de novo, week 1. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.35","ciUpperLimit":"1.00"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.058","pValueComment":"P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.71","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.02","ciUpperLimit":"1.45"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.032","pValueComment":"P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.83","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.07","ciUpperLimit":"1.59"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 2.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.762","pValueComment":"P-value is for de novo, week 2. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.66","ciUpperLimit":"0.90"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.029","pValueComment":"P-value is for de novo, week 3. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.91","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.09","ciUpperLimit":"1.73"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.010","pValueComment":"P-value is for de nove, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"1.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.27","ciUpperLimit":"1.97"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 3.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.619","pValueComment":"P-value is for de nove, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.21","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.63","ciUpperLimit":"1.06"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 4.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.058","pValueComment":"P-value is for de novo, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.83","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.03","ciUpperLimit":"1.69"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 4.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.001","pValueComment":"P-value is for de novo, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"1.51","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.61","ciUpperLimit":"2.41"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.142","pValueComment":"P-value is for de nove, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.68","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.23","ciUpperLimit":"1.58"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.065","pValueComment":"P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.85","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.05","ciUpperLimit":"1.76"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"1.70","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.75","ciUpperLimit":"2.65"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 5.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.079","pValueComment":"P-value is for de novo, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.85","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.10","ciUpperLimit":"1.79"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.093","pValueComment":"P-value is for de novo, 6 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.79","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.13","ciUpperLimit":"1.71"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.002","pValueComment":"P-value is for de novo, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"1.56","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.59","ciUpperLimit":"2.53"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 6.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.119","pValueComment":"P-value is for de novo, 6 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.77","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.20","ciUpperLimit":"1.74"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.036","pValueComment":"P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.98","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.06","ciUpperLimit":"1.91"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"1.65","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.68","ciUpperLimit":"2.61"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.178","pValueComment":"P-value is for de novo, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.66","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.30","ciUpperLimit":"1.63"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 8.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.093","pValueComment":"P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.81","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.14","ciUpperLimit":"1.75"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 7.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.003","pValueComment":"P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"1.52","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.53","ciUpperLimit":"2.51"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 1.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.157","pValueComment":"P-value is for de novo, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.72","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.28","ciUpperLimit":"1.71"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.063","pValueComment":"P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.89","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.05","ciUpperLimit":"1.82"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.001","pValueComment":"P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"1.68","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.70","ciUpperLimit":"2.66"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 9.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.114","pValueComment":"P-value is for de novo, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.79","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.19","ciUpperLimit":"1.77"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.295","pValueComment":"P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.51","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.44","ciUpperLimit":"1.46"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.005","pValueComment":"P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"1.44","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.45","ciUpperLimit":"2.44"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 10.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.066","pValueComment":"P-value is for de novo, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.94","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.06","ciUpperLimit":"1.94"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.208","pValueComment":"P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.62","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.35","ciUpperLimit":"1.58"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.004","pValueComment":"P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"1.50","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.49","ciUpperLimit":"2.51"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 11.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.086","pValueComment":"P-value is for de novo, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.88","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.13","ciUpperLimit":"1.89"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.328","pValueComment":"P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.48","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.49","ciUpperLimit":"1.45"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.005","pValueComment":"P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"1.46","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.44","ciUpperLimit":"2.47"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin de novo group in change in 24 hour average pain severity at Week 12.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.059","pValueComment":"P-value is for de novo, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.98","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.04","ciUpperLimit":"1.99"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.117","pValueComment":"P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.35","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.09","ciUpperLimit":"0.79"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.412","pValueComment":"P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.18","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.25","ciUpperLimit":"0.62"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 1.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.445","pValueComment":"P-value is for prior use, 1 week. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"-0.17","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.60","ciUpperLimit":"0.26"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.025","pValueComment":"P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.58","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.07","ciUpperLimit":"1.09"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.257","pValueComment":"P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.29","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.21","ciUpperLimit":"0.79"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 2.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.257","pValueComment":"P-value is for prior use, 2 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"-0.29","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.79","ciUpperLimit":"0.21"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.075","pValueComment":"P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.50","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.05","ciUpperLimit":"1.04"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.634","pValueComment":"P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.13","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.42","ciUpperLimit":"0.68"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 3.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.193","pValueComment":"P-value is for prior use, 3 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"-0.36","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.91","ciUpperLimit":"0.19"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.688","pValueComment":"P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.12","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.46","ciUpperLimit":"0.70"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.944","pValueComment":"P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"-0.02","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.60","ciUpperLimit":"0.56"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 4.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.640","pValueComment":"P-value is for prior use, 4 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"-0.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.73","ciUpperLimit":"0.45"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.439","pValueComment":"P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.24","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.37","ciUpperLimit":"0.84"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.461","pValueComment":"P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.23","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.38","ciUpperLimit":"0.84"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 5.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.976","pValueComment":"P-value is for prior use, 5 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"-0.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.62","ciUpperLimit":"0.60"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 6.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.829","pValueComment":"P-value is for prior use, 6 weeks. P-values are not adjusted for multiple comparisons. 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The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.58","ciUpperLimit":"0.67"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.447","pValueComment":"P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.24","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.38","ciUpperLimit":"0.85"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.511","pValueComment":"P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.21","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.41","ciUpperLimit":"0.83"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 7.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.924","pValueComment":"P-value is for prior use, 7 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"-0.03","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.65","ciUpperLimit":"0.59"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.185","pValueComment":"P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.43","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.20","ciUpperLimit":"1.06"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.403","pValueComment":"P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.27","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.37","ciUpperLimit":"0.91"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 8.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.636","pValueComment":"P-value is for prior use, 8 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"-0.15","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.79","ciUpperLimit":"0.49"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.304","pValueComment":"P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.33","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.30","ciUpperLimit":"0.95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.295","pValueComment":"P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.34","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.29","ciUpperLimit":"0.97"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 9.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.975","pValueComment":"P-value is for prior use, 9 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.01","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.62","ciUpperLimit":"0.64"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.349","pValueComment":"P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.30","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.33","ciUpperLimit":"0.93"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.351","pValueComment":"P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.30","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.34","ciUpperLimit":"0.94"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 10.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.992","pValueComment":"P-value is for prior use, 10 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.64","ciUpperLimit":"0.65"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.681","pValueComment":"P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.13","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.50","ciUpperLimit":"0.77"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.569","pValueComment":"P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.19","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.46","ciUpperLimit":"0.83"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 11.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.871","pValueComment":"P-value is for prior use, 11 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.05","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.60","ciUpperLimit":"0.70"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.675","pValueComment":"P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.14","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.50","ciUpperLimit":"0.78"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.823","pValueComment":"P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"0.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.57","ciUpperLimit":"0.72"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the gabapentin prior use group in change in 24 hour average pain severity at Week 12.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.850","pValueComment":"P-value is for prior use, 12 weeks. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Model Change=Investigator+ Treatment+Week+Subgroup+Baseline+Treatment\\*Week+ Baseline\\*Week+Subgroup\\*Week+Subgroup\\*Treatment+Subgroup\\*Treatment\\*Week","paramType":"Mean Difference (Final Values)","paramValue":"-0.06","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.72","ciUpperLimit":"0.59"}]},{"type":"SECONDARY","title":"Discontinuations for Abnormal Laboratory Analytes, Vital Signs, Overall and for Each Measure","description":"Presented are numbers of participants who discontinued due to a change from baseline in laboratory analytes or vital signs.","populationDescription":"All randomized patients.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"baseline through 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"134"},{"groupId":"OG001","value":"138"},{"groupId":"OG002","value":"135"}]}],"classes":[{"title":"Increased blood creatinine","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"}]}]},{"title":"Increased blood glucose","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 12 Weeks in Blood Pressure","description":"Least-squares means represent adjustment due to baseline severity and investigative site.","populationDescription":"All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"Standard Error","unitOfMeasure":"millimeter mercury","timeFrame":"baseline through 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"130"},{"groupId":"OG001","value":"133"},{"groupId":"OG002","value":"132"}]}],"classes":[{"title":"Diastolic","categories":[{"measurements":[{"groupId":"OG000","value":"0.18","spread":"0.92"},{"groupId":"OG001","value":"2.24","spread":"0.97"},{"groupId":"OG002","value":"-0.79","spread":"0.91"}]}]},{"title":"Systolic","categories":[{"measurements":[{"groupId":"OG000","value":"-3.31","spread":"1.44"},{"groupId":"OG001","value":"-3.08","spread":"1.54"},{"groupId":"OG002","value":"-2.08","spread":"1.43"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.448","pValueComment":"P-value is for diastolic. P-values are not adjusted for multiple comparisons. The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in diastolic blood pressure.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.118","pValueComment":"P-value is for diastolic. P-values are not adjusted for multiple comparisons. 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The a priori significance level was set to 0.05 for treatment comparisons and 0.10 for tests of interaction.","statisticalMethod":"Mixed Models Analysis","statisticalComment":"Change=Treatment+InvestigatorGroup+Week+Baseline+Treatment\\*Week+Baseline\\*Week; denominator degrees of freedom, Kenward-Rogers approximation","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in systolic blood pressure.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.537","pValueComment":"P-value is for systolic. P-values are not adjusted for multiple comparisons. 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Last-observation-carried-forward imputation was implemented.","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in GGT.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.832","pValueComment":"P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Variance model \\& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in AlkPhos.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.169","pValueComment":"P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Variance model \\& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in AlkPhos.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.910","pValueComment":"P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Variance model \\& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 in AlkPhos.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.134","pValueComment":"P-value is for AlkPhos. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Variance model \\& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 12 Weeks in Total Bilirubin","populationDescription":"All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"micromole/liter","timeFrame":"baseline, 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"120"},{"groupId":"OG001","value":"123"},{"groupId":"OG002","value":"120"}]}],"classes":[{"title":"baseline","categories":[{"measurements":[{"groupId":"OG000","value":"8.43","spread":"4.50"},{"groupId":"OG001","value":"8.07","spread":"3.99"},{"groupId":"OG002","value":"8.23","spread":"5.07"}]}]},{"title":"change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.51","spread":"3.48"},{"groupId":"OG001","value":"-0.28","spread":"2.60"},{"groupId":"OG002","value":"-0.42","spread":"3.39"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 total bilirubin.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.285","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Variance model \\& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 in total bilirubin.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.505","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Variance model \\& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 in total bilirubin.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.679","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Variance model \\& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 12 Weeks in Fasting Plasma Glucose","populationDescription":"All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimole/liter","timeFrame":"baseline, 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"82"},{"groupId":"OG002","value":"78"}]}],"classes":[{"title":"baseline","categories":[{"measurements":[{"groupId":"OG000","value":"8.24","spread":"3.31"},{"groupId":"OG001","value":"8.45","spread":"3.65"},{"groupId":"OG002","value":"7.99","spread":"3.82"}]}]},{"title":"change","categories":[{"measurements":[{"groupId":"OG000","value":"0.16","spread":"3.97"},{"groupId":"OG001","value":"0.19","spread":"2.86"},{"groupId":"OG002","value":"0.67","spread":"2.75"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.047","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Variance model \\& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.232","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Variance model \\& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in fasting blood glucose.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.424","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Variance model \\& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Mean Change From Baseline to 12 Weeks in Hemoglobin A1C","populationDescription":"All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) were included in the analysis.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"percent","timeFrame":"baseline, 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"117"},{"groupId":"OG001","value":"124"},{"groupId":"OG002","value":"119"}]}],"classes":[{"title":"baseline","categories":[{"measurements":[{"groupId":"OG000","value":"7.57","spread":"1.61"},{"groupId":"OG001","value":"7.51","spread":"1.44"},{"groupId":"OG002","value":"7.16","spread":"1.44"}]}]},{"title":"change","categories":[{"measurements":[{"groupId":"OG000","value":"-0.12","spread":"1.00"},{"groupId":"OG001","value":"-0.01","spread":"0.71"},{"groupId":"OG002","value":"0.07","spread":"0.80"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.298","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Variance model \\& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.987","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Variance model \\& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in mean change from baseline to 12 Weeks in hemoglobin A1C.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.297","pValueComment":"P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"t-test, 2 sided","statisticalComment":"Analysis of Variance model \\& t-test: Rank-transformed Change=InvestigatorGroup+Treatment. Last-observation-carried-forward imputation was implemented.","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Number of Patients With Treatment-Emergent Elevated Laboratory Analytes","description":"Treatment-emergent: within range at baseline, out of range after baseline. Ranges in Units/Liter (U/L). Aspartate Aminotransferase (AST): female (f): \\>34, male (m): \\>36. Alanine Aminotransferase (ALT): f:\\<69 years (yr) \\>34, ≥69yr \\>32; m: \\<69yr \\>43, ≥69yr \\>35. Total Bilirubin (TBili): \\>21. Gamma Glutamyl Transferase (GGT): f: \\<59yr \\>49, ≥59yr \\>50; m: \\<59yr \\>61, ≥59yr \\>50. Fasting Plasma Glucose (FPG): \\<59yr \\>6.4, ≥59yr \\>6.7. Hemoglobin A1C (HbA1C) \\>6%. Alkaline Phosphatase (AlkPhos): f: 18-50yr \\>106, 50-70yr \\>123, 70-80yr \\>164, ≥80yr \\>221; m: 18-50yr \\>129, 50-70yr \\>131, 70-80yr \\>156, ≥80yr \\>187","populationDescription":"All randomized participants with a baseline value and at least 1 non-missing post-baseline value (modified intent-to-treat population) and with baseline values within the normal range were included in the analysis.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"baseline through 12 weeks","groups":[{"id":"OG000","title":"Pregabalin","description":"Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US \\& Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US \\& Germany) or 150 mg BID (Canada), PO for 10 weeks."},{"id":"OG001","title":"Duloxetine","description":"Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks."},{"id":"OG002","title":"Gabapentin + Duloxetine","description":"Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"121"},{"groupId":"OG001","value":"124"},{"groupId":"OG002","value":"120"}]}],"classes":[{"title":"AST, n=113, n=116, n=109","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"4"}]}]},{"title":"ALT, n=111, n=104, n=110","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"10"}]}]},{"title":"TBili, n=119, n=121, n=116","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}]}]},{"title":"GGT, n=102, n=105, n=96","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"6"}]}]},{"title":"FPG, n=33, n=30, n=36","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"18"}]}]},{"title":"HbA1C, n=17, n=18, n=29","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"10"}]}]},{"title":"AlkPhos, n=112, n=114, n=113","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"4"}]}]}],"analyses":[{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AST values.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"1.00","pValueComment":"P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated AST values.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.749","pValueComment":"P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated AST values.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.750","pValueComment":"P-value is for AST. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated ALT values.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.050","pValueComment":"P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated ALT values.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.320","pValueComment":"P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated ALT values.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.440","pValueComment":"P-value is for ALT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated TBili values.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.498","pValueComment":"P-value is for TBili. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated TBili values.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.245","pValueComment":"P-value is for TBili. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated GGT values.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.160","pValueComment":"P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated GGT values.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.280","pValueComment":"P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG001","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between duloxetine and gabapentin+duloxetine in the number of participants with treatment-emergent elevated GGT values.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"1.00","pValueComment":"P-value is for GGT. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG002"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and gabapentin+duloxetine in the number of participants with treatment-emergent elevated FPG values.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.023","pValueComment":"P-value is for FPG. P-values are not adjusted for multiple comparisons. The a priori level of significance was specified to be 0.05 for between-treatment-group comparisons.","statisticalMethod":"Fisher Exact","ciPctValue":"95"},{"groupIds":["OG000","OG001"],"groupDescription":"Tested was the null-hypothesis that there would be no difference between pregabalin and duloxetine in the number of participants with treatment-emergent elevated FPG values.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.264","pValueComment":"P-value is for FPG. P-values are not adjusted for multiple comparisons. 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