{"protocolSection":{"identificationModule":{"nctId":"NCT01456936","orgStudyIdInfo":{"id":"A3051123"},"secondaryIdInfos":[{"id":"2010-022914-15","type":"EUDRACT_NUMBER"},{"id":"EAGLES","type":"OTHER","domain":"Alias Study Number"}],"organization":{"fullName":"Pfizer","class":"INDUSTRY"},"briefTitle":"Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders","officialTitle":"A Phase 4, Randomized, Double-blind, Active And Placebo-controlled, Multicenter Study Evaluating The Neuropsychiatric Safety And Efficacy Of 12 Weeks Varenicline Tartrate 1mg Bid And Bupropion Hydrochloride 150mg Bid For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders","acronym":"EAGLES"},"statusModule":{"statusVerifiedDate":"2016-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2011-11"},"primaryCompletionDateStruct":{"date":"2015-01","type":"ACTUAL"},"completionDateStruct":{"date":"2015-01","type":"ACTUAL"},"studyFirstSubmitDate":"2011-10-14","studyFirstSubmitQcDate":"2011-10-19","studyFirstPostDateStruct":{"date":"2011-10-21","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-01-12","resultsFirstSubmitQcDate":"2016-03-29","resultsFirstPostDateStruct":{"date":"2016-05-02","type":"ESTIMATED"},"lastUpdateSubmitDate":"2016-05-09","lastUpdatePostDateStruct":{"date":"2016-06-10","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Pfizer","class":"INDUSTRY"},"collaborators":[{"name":"GlaxoSmithKline","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (AEs) in both of these populations)."},"conditionsModule":{"conditions":["Smoking Cessation"],"keywords":["smoking cessation","psychiatric disease"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":8144,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"placebo","type":"PLACEBO_COMPARATOR","description":"Subjects randomized to placebo will receive placebo treatments for all three study drugs. Blinded placebo will be provided for varenicline, bupropion hydrochloride and transdermal nicotine patch (NRT). In addition, subjects will receive blinded placebo treatments for the study drugs they are not randomized to receive.","interventionNames":["Drug: Placebo"]},{"label":"varenicline","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: varenicline tartrate"]},{"label":"bupropion","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: bupropion hydrochloride"]},{"label":"Nicotine Replacement Therapy Patch","type":"ACTIVE_COMPARATOR","interventionNames":["Drug: Nicotine Replacement Therapy Patch"]}],"interventions":[{"type":"DRUG","name":"Placebo","description":"Triple dummy placebo for each treatment arm","armGroupLabels":["placebo"]},{"type":"DRUG","name":"varenicline tartrate","description":"Subjects will be titrated to the full dose during the first week in the following manner: 0.5 mg (tablet form) once a day for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 11 weeks","armGroupLabels":["varenicline"],"otherNames":["Chantix; Champix"]},{"type":"DRUG","name":"bupropion hydrochloride","description":"Subjects will receive 150 mg (tablet form) once a day for 3 days and then will take 150 mg twice a day for the remainder of the treatment period (11 weeks and 4 days).","armGroupLabels":["bupropion"]},{"type":"DRUG","name":"Nicotine Replacement Therapy Patch","description":"Subjects will start active dosing the morning of the Week 1 visit and will receive a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment.","armGroupLabels":["Nicotine Replacement Therapy Patch"],"otherNames":["NRT"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint","description":"The primary safety endpoint is the occurrence of at least one treatment emergent \"severe\" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent \"moderate\" or \"severe\" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide.","timeFrame":"Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days."},{"measure":"Estimated NPS AE Rate (%), by Cohort","description":"The primary safety endpoint is the occurrence of at least one treatment emergent \"severe\" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent \"moderate\" or \"severe\" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Estimated NPS AE rate (%) was calculated based on least-squares means analysis.","timeFrame":"Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days."}],"secondaryOutcomes":[{"measure":"Occurrence of the Components of the NPS AE Primary Endpoint, Non-psychiatric History Cohort","description":"The safety endpoint is the occurrence of at least one treatment emergent \"severe\" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent \"moderate\" or \"severe\" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below.","timeFrame":"Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days."},{"measure":"Occurrence of the Components of the NPS AE Primary Endpoint, Psychiatric History Cohort","description":"The safety endpoint is the occurrence of at least one treatment emergent \"severe\" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent \"moderate\" or \"severe\" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below.","timeFrame":"Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days."},{"measure":"Occurrence of the Components of NPS AE Primary Endpoint (Overall)","description":"The NPS AE composite results (as previously described) are for the two cohorts combined and are presented below.","timeFrame":"Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days."},{"measure":"Occurrence of Severe-only NPS AEs in the Primary Endpoint, by Cohort","description":"The primary safety endpoint is the occurrence of at least one treatment emergent \"severe\" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent \"moderate\" or \"severe\" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.","timeFrame":"Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days."},{"measure":"Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Non-psychiatric History Cohort","description":"The safety endpoint is the occurrence of at least one treatment emergent \"severe\" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent \"moderate\" or \"severe\" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.","timeFrame":"Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days."},{"measure":"Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Psychiatric History Cohort","description":"The safety endpoint is the occurrence of at least one treatment emergent \"severe\" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent \"moderate\" or \"severe\" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.","timeFrame":"Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days."},{"measure":"Occurrence of the Components of Severe-only NPS AE Endpoint (Overall)","description":"The NPS AE endpoint was the occurrence of at least 1 treatment-emergent \"severe\" AE of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least 1 treatment-emergent \"severe\" AE of agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.","timeFrame":"Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days."},{"measure":"Hospital Anxiety and Depression Scale (HADS) Total Score, Non-psychiatric History Cohort","description":"The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.","timeFrame":"Baseline to Week 24"},{"measure":"HADS Total Score, Psychiatric History Cohort","description":"The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.","timeFrame":"Baseline to Week 24"},{"measure":"HADS Total Score (Overall)","description":"The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.","timeFrame":"Baseline to Week 24"},{"measure":"Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Non-psychiatric History Cohort","description":"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from \"wish to be dead\" to \"active suicidal ideation with specific plan and intent\". Answers at screening are for lifetime history. Answers for all other visits are since last visit.The scale is also used to record any completed suicides.","timeFrame":"Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days."},{"measure":"Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Psychiatric History Cohort","description":"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from \"wish to be dead\" to \"active suicidal ideation with specific plan and intent\". Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides.","timeFrame":"Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days."},{"measure":"Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Overall","description":"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from \"wish to be dead\" to \"active suicidal ideation with specific plan and intent\". Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides.","timeFrame":"Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days."},{"measure":"Clinical Global Impression of Improvement (CGI-I), \"No Change\" Rating by Visit","description":"The CGI-I is a clinician rated instrument that measures change in participant's psychiatric condition (or lack thereof in the stratum without psychiatric disorders) on a 7 point scale ranging from 1 (very much improved) to 7 (very much worse), with 4 = no change. The ratings were applicable even to those without psychiatric diagnoses (eg, those with no psychiatric symptoms would be rated as \"normal, not at all ill\" on the CGI-S at baseline and assuming no psychiatric symptoms emerge during the trial, would be rated as \"no change\" on the CGI-I at follow-up visits). For those participants with a psychiatric diagnosis, the clinician should rate the severity of the mental illness with respect to the clinician's experience with the psychiatric population to which the participant belongs.","timeFrame":"Baseline to Week 24"},{"measure":"CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Non-psychiatric History Cohort","description":"A responder to this endpoint requires the answer \"no\" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).","timeFrame":"Week 9 through Week 12"},{"measure":"CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Psychiatric History Cohort","description":"A responder to this endpoint requires the answer \"no\" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).","timeFrame":"Week 9 through Week 12"},{"measure":"CO-Confirmed Continuous Abstinence for Weeks 9 Through 12 (Overall)","description":"A responder to this endpoint requires the answer \"no\" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).","timeFrame":"Week 9 through Week 12"},{"measure":"CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Non-psychiatric History Cohort","description":"A responder to this endpoint requires the answer \"no\" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).","timeFrame":"Week 9 through Week 24"},{"measure":"CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Psychiatric History Cohort","description":"A responder to this endpoint requires the answer \"no\" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).","timeFrame":"Week 9 through Week 24"},{"measure":"CO-confirmed Continuous Abstinence From Week 9 Through Week 24 (Overall)","description":"A responder to this endpoint requires the answer \"no\" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).","timeFrame":"Week 9 through Week 24"},{"measure":"7-Day Point Prevalence of Abstinence, Non-psychiatric History Cohort","description":"A responder to this endpoint requires the answer \"no\" to both questions 3 and 6 on the nicotine use inventory at that specific visit.\n\nNUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?","timeFrame":"24 Weeks"},{"measure":"7-Day Point Prevalence of Abstinence, Psychiatric History Cohort","description":"A responder to this endpoint requires the answer \"no\" to both questions 3 and 6 on the nicotine use inventory at that specific visit.\n\nNUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?","timeFrame":"24 Weeks"},{"measure":"7-Day Point Prevalence of Abstinence (Overall)","description":"A responder to this endpoint requires the answer \"no\" to both questions 3 and 6 on the nicotine use inventory at that specific visit.\n\nNUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?","timeFrame":"24 Weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female cigarette smokers, 18- 75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt.\n* Smoked an average of at least 10 cigarettes per day during past year and during the month prior to the screening visit, and exhaled carbon monoxide (CO) \\>10 ppm at screening.\n* For Neuropsychiatric cohort- subjects must have proper diagnosis as outlined in protocol.\n\nExclusion Criteria:\n\n* Subjects with a past or current diagnosis of one of the following disorders:\n\n  a. Psychotic Disorders:\n* Schizophreniform\n* Delusional Disorder\n* Psychotic Disorder NOS b. All Delirium, Dementia, and Amnestic and Other Cognitive Disorders c. All Substance Induced Disorders (Other than nicotine)","healthyVolunteers":true,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Pfizer CT.gov Call Center","affiliation":"Pfizer","role":"STUDY_DIRECTOR"}],"locations":[{"facility":"Coastal Clinical Research, Inc.","city":"Mobile","state":"Alabama","zip":"36608","country":"United States","geoPoint":{"lat":30.69436,"lon":-88.04305}},{"facility":"NoesisPharma Research","city":"Phoenix","state":"Arizona","zip":"85032","country":"United States","geoPoint":{"lat":33.44838,"lon":-112.07404}},{"facility":"Pharmacology Research Institute","city":"Encino","state":"California","zip":"91316","country":"United States","geoPoint":{"lat":34.15917,"lon":-118.50119}},{"facility":"Synergy Clinical Research of Escondido","city":"Escondido","state":"California","zip":"92025","country":"United 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Do tobacco regulatory and economic factors influence smoking cessation outcomes? A post-hoc analysis of the multinational EAGLES randomised controlled trial. BMJ Open. 2024 Sep 20;14(9):e079092. doi: 10.1136/bmjopen-2023-079092."},{"pmid":"35611069","type":"DERIVED","citation":"Tonnesen P, Lawrence D, Tonstad S. Medication-assisted quit rates in participants with smoking-related diseases in EAGLES: Post hoc analyses of a double-blind, randomized, placebo-controlled clinical trial. Tob Induc Dis. 2022 May 10;20:46. doi: 10.18332/tid/146567. eCollection 2022."},{"pmid":"35535436","type":"DERIVED","citation":"Cinciripini PM, Kypriotakis G, Green C, Lawrence D, Anthenelli RM, Minnix J, Blalock JA, Beneventi D, Morris C, Karam-Hage M. The effects of varenicline, bupropion, nicotine patch, and placebo on smoking cessation among smokers with major depression: A randomized clinical trial. Depress Anxiety. 2022 May;39(5):429-440. doi: 10.1002/da.23259."},{"pmid":"34481605","type":"DERIVED","citation":"Ebbert JO, Jimenez-Ruiz C, Dutro MP, Fisher M, Li J, Hays JT. In Reply: Changing the Culture of Tobacco Dependence Treatment Among Not Only Patients, But Also Prescribers. Mayo Clin Proc. 2021 Sep;96(9):2495. doi: 10.1016/j.mayocp.2021.07.010. No abstract available."},{"pmid":"34112520","type":"DERIVED","citation":"Ebbert J, Jimenez-Ruiz C, Dutro MP, Fisher M, Li J, Hays JT. Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial. Mayo Clin Proc. 2021 Jul;96(7):1801-1811. doi: 10.1016/j.mayocp.2020.10.046. Epub 2021 Jun 8."},{"pmid":"33885203","type":"DERIVED","citation":"Beard E, Jackson SE, Anthenelli RM, Benowitz NL, Aubin LS, McRae T, Lawrence D, Russ C, Krishen A, Evins AE, West R. Estimation of risk of neuropsychiatric adverse events from varenicline, bupropion and nicotine patch versus placebo: secondary analysis of results from the EAGLES trial using Bayes factors. Addiction. 2021 Oct;116(10):2816-2824. doi: 10.1111/add.15440. Epub 2021 Apr 22."},{"pmid":"33788933","type":"DERIVED","citation":"Correa JB, Lawrence D, McKenna BS, Gaznick N, Saccone PA, Dubrava S, Doran N, Anthenelli RM. Psychiatric Comorbidity and Multimorbidity in the EAGLES Trial: Descriptive Correlates and Associations With Neuropsychiatric Adverse Events, Treatment Adherence, and Smoking Cessation. Nicotine Tob Res. 2021 Aug 29;23(10):1646-1655. doi: 10.1093/ntr/ntab056."},{"pmid":"33464316","type":"DERIVED","citation":"Nollen NL, Ahluwalia JS, Sanderson Cox L, Okuyemi K, Lawrence D, Samuels L, Benowitz NL. Assessment of Racial Differences in Pharmacotherapy Efficacy for Smoking Cessation: Secondary Analysis of the EAGLES Randomized Clinical Trial. JAMA Netw Open. 2021 Jan 4;4(1):e2032053. doi: 10.1001/jamanetworkopen.2020.32053."},{"pmid":"33138708","type":"DERIVED","citation":"Evins AE, West R, Benowitz NL, Russ C, Lawrence D, McRae T, Maravic MC, Heffner JL, Anthenelli RM. Efficacy and Safety of Pharmacotherapeutic Smoking Cessation Aids in Schizophrenia Spectrum Disorders: Subgroup Analysis of EAGLES. Psychiatr Serv. 2021 Jan 1;72(1):7-15. doi: 10.1176/appi.ps.202000032. Epub 2020 Nov 3."},{"pmid":"31850603","type":"DERIVED","citation":"Ayers CR, Heffner JL, Russ C, Lawrence D, McRae T, Evins AE, Anthenelli RM. Efficacy and safety of pharmacotherapies for smoking cessation in anxiety disorders: Subgroup analysis of the randomized, active- and placebo-controlled EAGLES trial. Depress Anxiety. 2020 Mar;37(3):247-260. doi: 10.1002/da.22982. Epub 2019 Dec 18."},{"pmid":"31195244","type":"DERIVED","citation":"Heffner JL, Evins AE, Russ C, Lawrence D, Ayers CR, McRae T, Aubin LS, Krishen A, West R, Anthenelli RM. Safety and efficacy of first-line smoking cessation pharmacotherapies in bipolar disorders: Subgroup analysis of a randomized clinical trial. J Affect Disord. 2019 Sep 1;256:267-277. doi: 10.1016/j.jad.2019.06.008. Epub 2019 Jun 3."},{"pmid":"30847828","type":"DERIVED","citation":"Anthenelli RM, Gaffney M, Benowitz NL, West R, McRae T, Russ C, Lawrence D, St Aubin L, Krishen A, Evins AE. Predictors of Neuropsychiatric Adverse Events with Smoking Cessation Medications in the Randomized Controlled EAGLES Trial. J Gen Intern Med. 2019 Jun;34(6):862-870. doi: 10.1007/s11606-019-04858-2. Epub 2019 Mar 7."},{"pmid":"29508470","type":"DERIVED","citation":"West R, Evins AE, Benowitz NL, Russ C, McRae T, Lawrence D, St Aubin L, Krishen A, Maravic MC, Anthenelli RM. Factors associated with the efficacy of smoking cessation treatments and predictors of smoking abstinence in EAGLES. Addiction. 2018 Aug;113(8):1507-1516. doi: 10.1111/add.14208. Epub 2018 Mar 30."},{"pmid":"27116918","type":"DERIVED","citation":"Anthenelli RM, Benowitz NL, West R, St Aubin L, McRae T, Lawrence D, Ascher J, Russ C, Krishen A, Evins AE. Neuropsychiatric safety and efficacy of varenicline, bupropion, and nicotine patch in smokers with and without psychiatric disorders (EAGLES): a double-blind, randomised, placebo-controlled clinical trial. Lancet. 2016 Jun 18;387(10037):2507-20. doi: 10.1016/S0140-6736(16)30272-0. Epub 2016 Apr 22."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Participants were classified into 2 cohorts: participants without diagnosis of psychiatric disorder and participants with a stable diagnosis of psychiatric disorder confirmed by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID) 4th edition conducted at screening.","recruitmentDetails":"A total of 11,186 participants were screened for participation in the study, of which 3042 participants were considered to be screen failures, leaving 8144 participants eligible for study participation (efficacy population). 86 participants (1.1%) did not receive study drug. A total of 8058 participants received study drug (safety population).","groups":[{"id":"FG000","title":"Varenicline","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg daily once (QD) x 3 days, 0.5 mg twice daily (BID) x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"FG001","title":"Bupropion","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"FG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"FG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"2037"},{"groupId":"FG001","numSubjects":"2034"},{"groupId":"FG002","numSubjects":"2038"},{"groupId":"FG003","numSubjects":"2035"}]},{"type":"Randomized and Treated","achievements":[{"groupId":"FG000","numSubjects":"2016"},{"groupId":"FG001","numSubjects":"2006"},{"groupId":"FG002","numSubjects":"2022"},{"groupId":"FG003","numSubjects":"2014"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1598"},{"groupId":"FG001","numSubjects":"1586"},{"groupId":"FG002","numSubjects":"1557"},{"groupId":"FG003","numSubjects":"1552"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"439"},{"groupId":"FG001","numSubjects":"448"},{"groupId":"FG002","numSubjects":"481"},{"groupId":"FG003","numSubjects":"483"}]}],"dropWithdraws":[{"type":"Other reason","reasons":[{"groupId":"FG000","numSubjects":"41"},{"groupId":"FG001","numSubjects":"30"},{"groupId":"FG002","numSubjects":"36"},{"groupId":"FG003","numSubjects":"33"}]},{"type":"No longer meets eligibility criteria","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"6"},{"groupId":"FG003","numSubjects":"5"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"5"},{"groupId":"FG003","numSubjects":"5"}]},{"type":"Pregnancy","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Insufficient clinical response","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"14"},{"groupId":"FG003","numSubjects":"13"}]},{"type":"No longer willing to participate","reasons":[{"groupId":"FG000","numSubjects":"195"},{"groupId":"FG001","numSubjects":"218"},{"groupId":"FG002","numSubjects":"224"},{"groupId":"FG003","numSubjects":"248"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"135"},{"groupId":"FG001","numSubjects":"126"},{"groupId":"FG002","numSubjects":"144"},{"groupId":"FG003","numSubjects":"127"}]},{"type":"Medication error","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Adverse event (study drug)","reasons":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"21"},{"groupId":"FG002","numSubjects":"26"},{"groupId":"FG003","numSubjects":"17"}]},{"type":"Adverse event (study drug unrelated)","reasons":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"9"},{"groupId":"FG003","numSubjects":"9"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"3"}]},{"type":"Randomized but not treated","reasons":[{"groupId":"FG000","numSubjects":"21"},{"groupId":"FG001","numSubjects":"28"},{"groupId":"FG002","numSubjects":"16"},{"groupId":"FG003","numSubjects":"21"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The safety analysis population contained all treated participants i.e. who received at least one partial dose of study medication.","groups":[{"id":"BG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"BG001","title":"Bupropion","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"BG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"BG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"2016"},{"groupId":"BG001","value":"2006"},{"groupId":"BG002","value":"2022"},{"groupId":"BG003","value":"2014"},{"groupId":"BG004","value":"8058"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"46.5","spread":"12.4"},{"groupId":"BG001","value":"46.3","spread":"12.6"},{"groupId":"BG002","value":"46.8","spread":"12.2"},{"groupId":"BG003","value":"46.4","spread":"12.2"},{"groupId":"BG004","value":"46.5","spread":"12.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1114"},{"groupId":"BG001","value":"1116"},{"groupId":"BG002","value":"1141"},{"groupId":"BG003","value":"1138"},{"groupId":"BG004","value":"4509"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"902"},{"groupId":"BG001","value":"890"},{"groupId":"BG002","value":"881"},{"groupId":"BG003","value":"876"},{"groupId":"BG004","value":"3549"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint","description":"The primary safety endpoint is the occurrence of at least one treatment emergent \"severe\" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent \"moderate\" or \"severe\" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide.","populationDescription":"The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2016"},{"groupId":"OG001","value":"2006"},{"groupId":"OG002","value":"2022"},{"groupId":"OG003","value":"2014"}]}],"classes":[{"title":"Non-psychiatric cohort (N= 990, 989, 1006, 999)","categories":[{"measurements":[{"groupId":"OG000","value":"1.3"},{"groupId":"OG001","value":"2.2"},{"groupId":"OG002","value":"2.5"},{"groupId":"OG003","value":"2.4"}]}]},{"title":"Psychiatric cohort (N= 1026, 1017, 1016, 1015)","categories":[{"measurements":[{"groupId":"OG000","value":"6.5"},{"groupId":"OG001","value":"6.7"},{"groupId":"OG002","value":"5.2"},{"groupId":"OG003","value":"4.9"}]}]},{"title":"Overall (N= 2016, 2006, 2022, 2014)","categories":[{"measurements":[{"groupId":"OG000","value":"4.0"},{"groupId":"OG001","value":"4.5"},{"groupId":"OG002","value":"3.9"},{"groupId":"OG003","value":"3.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003"],"groupDescription":"The reduced (final) statistical model included treatment group, cohort and region, plus the 2-way interaction of treatment by cohort. Other interactions not included due to lack of significance. Region reduced to 2-level to address event sparseness issue.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.0652","pValueComment":"An interaction between treatment and cohort was considered significant at 10% level. No multiplicity adjustments were utilized.","statisticalMethod":"Regression, Linear","statisticalComment":"A generalized linear regression analysis based on the safety analysis set was used to evaluate incidence of NPS AE as the primary analysis."}]},{"type":"PRIMARY","title":"Estimated NPS AE Rate (%), by Cohort","description":"The primary safety endpoint is the occurrence of at least one treatment emergent \"severe\" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent \"moderate\" or \"severe\" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Estimated NPS AE rate (%) was calculated based on least-squares means analysis.","populationDescription":"The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.","reportingStatus":"POSTED","paramType":"LEAST_SQUARES_MEAN","dispersionType":"95% Confidence Interval","unitOfMeasure":"percentage of participants","timeFrame":"Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2016"},{"groupId":"OG001","value":"2006"},{"groupId":"OG002","value":"2022"},{"groupId":"OG003","value":"2014"}]}],"classes":[{"title":"Non-psychiatric cohort (N=3984)","categories":[{"measurements":[{"groupId":"OG000","value":"1.25","lowerLimit":"0.60","upperLimit":"1.90"},{"groupId":"OG001","value":"2.44","lowerLimit":"1.52","upperLimit":"3.36"},{"groupId":"OG002","value":"2.31","lowerLimit":"1.37","upperLimit":"3.25"},{"groupId":"OG003","value":"2.52","lowerLimit":"1.58","upperLimit":"3.46"}]}]},{"title":"Psychiatric cohort (N= 4074)","categories":[{"measurements":[{"groupId":"OG000","value":"6.42","lowerLimit":"4.91","upperLimit":"7.93"},{"groupId":"OG001","value":"6.62","lowerLimit":"5.09","upperLimit":"8.15"},{"groupId":"OG002","value":"5.20","lowerLimit":"3.84","upperLimit":"6.56"},{"groupId":"OG003","value":"4.83","lowerLimit":"3.51","upperLimit":"6.16"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"groupDescription":"Non-psychiatric cohort","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Linear","paramType":"Risk Difference (RD)","paramValue":"-1.28","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.40","ciUpperLimit":"-0.15","estimateComment":"Risk difference for varenicline versus placebo from estimation model."},{"groupIds":["OG001","OG003"],"groupDescription":"Non-psychiatric cohort","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Linear","paramType":"Risk Difference (RD)","paramValue":"-0.08","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.37","ciUpperLimit":"1.21","estimateComment":"Risk difference for bupropion 150 mg BID versus placebo from estimation model."},{"groupIds":["OG002","OG003"],"groupDescription":"Non-psychiatric cohort","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Linear","paramType":"Risk Difference (RD)","paramValue":"-0.21","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.54","ciUpperLimit":"1.12","estimateComment":"Risk difference for NRT versus placebo from estimation model."},{"groupIds":["OG000","OG003"],"groupDescription":"Psychiatric cohort","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Linear","paramType":"Risk Difference (RD)","paramValue":"1.59","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.42","ciUpperLimit":"3.59","estimateComment":"Risk difference for varenicline versus placebo from estimation model"},{"groupIds":["OG001","OG003"],"groupDescription":"Psychiatric cohort","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Linear","paramType":"Risk Difference (RD)","paramValue":"1.78","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-0.24","ciUpperLimit":"3.81","estimateComment":"Risk difference for bupropion 150 mg BID versus placebo from estimation model."},{"groupIds":["OG002","OG003"],"groupDescription":"Psychiatric cohort","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","statisticalMethod":"Regression, Linear","paramType":"Risk Difference (RD)","paramValue":"0.37","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.53","ciUpperLimit":"2.26","estimateComment":"Risk difference for NRT versus placebo from estimation model."}]},{"type":"SECONDARY","title":"Occurrence of the Components of the NPS AE Primary Endpoint, Non-psychiatric History Cohort","description":"The safety endpoint is the occurrence of at least one treatment emergent \"severe\" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent \"moderate\" or \"severe\" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below.","populationDescription":"The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"990"},{"groupId":"OG001","value":"989"},{"groupId":"OG002","value":"1006"},{"groupId":"OG003","value":"999"}]}],"classes":[{"title":"Anxiety (severe)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"3"}]}]},{"title":"Depression (severe)","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Feeling abnormal (severe only)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Hostility (severe)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}]},{"title":"Agitation (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"19"},{"groupId":"OG003","value":"11"}]}]},{"title":"Aggression (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"3"}]}]},{"title":"Delusions (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}]},{"title":"Hallucinations (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Mania (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"}]}]},{"title":"Panic (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"3"}]}]},{"title":"Paranoia (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Psychosis (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}]},{"title":"Homicidal ideation (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}]},{"title":"Suicidal behavior (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}]},{"title":"Suicidal ideation (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"3"}]}]},{"title":"Suicide (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]}]},{"type":"SECONDARY","title":"Occurrence of the Components of the NPS AE Primary Endpoint, Psychiatric History Cohort","description":"The safety endpoint is the occurrence of at least one treatment emergent \"severe\" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent \"moderate\" or \"severe\" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Each of these 16 components is reported below.","populationDescription":"The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1026"},{"groupId":"OG001","value":"1017"},{"groupId":"OG002","value":"1016"},{"groupId":"OG003","value":"1015"}]}],"classes":[{"title":"Anxiety (severe)","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"2"}]}]},{"title":"Depression (severe)","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"6"}]}]},{"title":"Feeling abnormal (severe only)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Hostility (severe)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Agitation (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"25"},{"groupId":"OG001","value":"29"},{"groupId":"OG002","value":"21"},{"groupId":"OG003","value":"22"}]}]},{"title":"Aggression (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"14"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"8"}]}]},{"title":"Delusions (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}]},{"title":"Hallucinations (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"}]}]},{"title":"Mania (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"}]}]},{"title":"Panic (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"16"},{"groupId":"OG002","value":"13"},{"groupId":"OG003","value":"7"}]}]},{"title":"Paranoia (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"}]}]},{"title":"Psychosis (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"1"}]}]},{"title":"Homicidal ideation (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Suicidal behavior (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]},{"title":"Suicidal ideation (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"2"}]}]},{"title":"Suicide (moderate and severe)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]}]},{"type":"SECONDARY","title":"Occurrence of the Components of NPS AE Primary Endpoint (Overall)","description":"The NPS AE composite results (as previously described) are for the two cohorts combined and are presented below.","populationDescription":"The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2016"},{"groupId":"OG001","value":"2006"},{"groupId":"OG002","value":"2022"},{"groupId":"OG003","value":"2014"}]}],"classes":[{"title":"Anxiety","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"5"}]}]},{"title":"Depression","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"6"}]}]},{"title":"Feeling Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Hostility","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}]},{"title":"Agitation","categories":[{"measurements":[{"groupId":"OG000","value":"35"},{"groupId":"OG001","value":"40"},{"groupId":"OG002","value":"40"},{"groupId":"OG003","value":"33"}]}]},{"title":"Aggression","categories":[{"measurements":[{"groupId":"OG000","value":"17"},{"groupId":"OG001","value":"12"},{"groupId":"OG002","value":"9"},{"groupId":"OG003","value":"11"}]}]},{"title":"Delusions","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"}]}]},{"title":"Hallucination","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"2"}]}]},{"title":"Mania","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"10"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"8"}]}]},{"title":"Panic Disorder","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"20"},{"groupId":"OG002","value":"14"},{"groupId":"OG003","value":"10"}]}]},{"title":"Paranoia","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"}]}]},{"title":"Psychosis","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"1"}]}]},{"title":"Homicidal Ideation","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}]},{"title":"Suicidal Behavior","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}]}]},{"title":"Suicidal Ideation","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"3"},{"groupId":"OG002","value":"5"},{"groupId":"OG003","value":"5"}]}]},{"title":"Suicide","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]}]},{"type":"SECONDARY","title":"Occurrence of Severe-only NPS AEs in the Primary Endpoint, by Cohort","description":"The primary safety endpoint is the occurrence of at least one treatment emergent \"severe\" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent \"moderate\" or \"severe\" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.","populationDescription":"The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2016"},{"groupId":"OG001","value":"2006"},{"groupId":"OG002","value":"2022"},{"groupId":"OG003","value":"2014"}]}],"classes":[{"title":"Non-psychiatric cohort (N= 990, 989, 1006, 999)","categories":[{"measurements":[{"groupId":"OG000","value":"0.1"},{"groupId":"OG001","value":"0.4"},{"groupId":"OG002","value":"0.3"},{"groupId":"OG003","value":"0.5"}]}]},{"title":"Psychiatric cohort (N= 1026, 1017, 1016, 1015)","categories":[{"measurements":[{"groupId":"OG000","value":"1.4"},{"groupId":"OG001","value":"1.4"},{"groupId":"OG002","value":"1.4"},{"groupId":"OG003","value":"1.3"}]}]},{"title":"Overall (N= 2016, 2006, 2022, 2014)","categories":[{"measurements":[{"groupId":"OG000","value":"0.7"},{"groupId":"OG001","value":"0.9"},{"groupId":"OG002","value":"0.8"},{"groupId":"OG003","value":"0.9"}]}]}]},{"type":"SECONDARY","title":"Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Non-psychiatric History Cohort","description":"The safety endpoint is the occurrence of at least one treatment emergent \"severe\" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent \"moderate\" or \"severe\" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. Only those events rated as severe are reported; this excludes any moderate events in the primary NPS AE endpoint.","populationDescription":"The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"990"},{"groupId":"OG001","value":"989"},{"groupId":"OG002","value":"1006"},{"groupId":"OG003","value":"999"}]}],"classes":[{"title":"Anxiety","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"3"}]}]},{"title":"Depression","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Feeling abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Hostility","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}]},{"title":"Agitation","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"0"}]}]},{"title":"Aggression","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Delusions","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Hallucinations","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Mania","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Panic","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}]}]},{"title":"Paranoia","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Psychosis","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Homicidal ideation","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Suicidal behavior","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Suicidal ideation","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]},{"title":"Suicide","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]}]},{"type":"SECONDARY","title":"Occurrence of the Components of the Observed Severe-only NPS AE Primary Endpoint, Psychiatric History Cohort","description":"The safety endpoint is the occurrence of at least one treatment emergent \"severe\" adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment emergent \"moderate\" or \"severe\" adverse event of: agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide. 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They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. 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They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2016"},{"groupId":"OG001","value":"2006"},{"groupId":"OG002","value":"2022"},{"groupId":"OG003","value":"2014"}]}],"classes":[{"title":"Anxiety","categories":[{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"5"}]}]},{"title":"Depression","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"6"}]}]},{"title":"Feeling Abnormal","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Hostility","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}]},{"title":"Agitation","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"6"},{"groupId":"OG003","value":"2"}]}]},{"title":"Aggression","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]},{"title":"Delusions","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Hallucination","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Mania","categories":[{"measurements":[{"groupId":"OG000","value":"2"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Panic Disorder","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"2"}]}]},{"title":"Paranoia","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"}]}]},{"title":"Psychosis","categories":[{"measurements":[{"groupId":"OG000","value":"4"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"4"},{"groupId":"OG003","value":"1"}]}]},{"title":"Suicidal Behavior","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]},{"title":"Suicidal Ideation","categories":[{"measurements":[{"groupId":"OG000","value":"1"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}]},{"title":"Suicide","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]},{"title":"Homicidal Ideation","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"0"}]}]}]},{"type":"SECONDARY","title":"Hospital Anxiety and Depression Scale (HADS) Total Score, Non-psychiatric History Cohort","description":"The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.","populationDescription":"The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"Baseline to Week 24","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"990"},{"groupId":"OG001","value":"989"},{"groupId":"OG002","value":"1006"},{"groupId":"OG003","value":"999"}]}],"classes":[{"title":"Week 1 (N= 984, 972, 989, 992)","categories":[{"measurements":[{"groupId":"OG000","value":"3.26","spread":"3.92"},{"groupId":"OG001","value":"3.58","spread":"4.25"},{"groupId":"OG002","value":"3.06","spread":"3.87"},{"groupId":"OG003","value":"3.38","spread":"4.20"}]}]},{"title":"Week 2 (N= 961, 954, 963, 970)","categories":[{"measurements":[{"groupId":"OG000","value":"2.91","spread":"3.86"},{"groupId":"OG001","value":"3.07","spread":"3.96"},{"groupId":"OG002","value":"2.84","spread":"3.85"},{"groupId":"OG003","value":"3.20","spread":"4.25"}]}]},{"title":"Week 3 (N= 935, 930, 936, 941)","categories":[{"measurements":[{"groupId":"OG000","value":"2.61","spread":"3.85"},{"groupId":"OG001","value":"2.64","spread":"3.82"},{"groupId":"OG002","value":"2.63","spread":"3.93"},{"groupId":"OG003","value":"2.77","spread":"3.94"}]}]},{"title":"Week 4 (N= 923, 916, 934, 923)","categories":[{"measurements":[{"groupId":"OG000","value":"2.40","spread":"3.66"},{"groupId":"OG001","value":"2.36","spread":"3.57"},{"groupId":"OG002","value":"2.46","spread":"3.80"},{"groupId":"OG003","value":"2.77","spread":"4.21"}]}]},{"title":"Week 5 (N= 911, 897, 906, 902)","categories":[{"measurements":[{"groupId":"OG000","value":"2.29","spread":"3.51"},{"groupId":"OG001","value":"2.24","spread":"3.52"},{"groupId":"OG002","value":"2.32","spread":"3.86"},{"groupId":"OG003","value":"2.48","spread":"3.92"}]}]},{"title":"Week 6 (N= 899, 893, 909, 897)","categories":[{"measurements":[{"groupId":"OG000","value":"2.23","spread":"3.56"},{"groupId":"OG001","value":"2.18","spread":"3.57"},{"groupId":"OG002","value":"2.40","spread":"3.87"},{"groupId":"OG003","value":"2.48","spread":"3.97"}]}]},{"title":"Week 8 (N= 868, 861, 877, 877)","categories":[{"measurements":[{"groupId":"OG000","value":"2.17","spread":"3.60"},{"groupId":"OG001","value":"2.16","spread":"3.70"},{"groupId":"OG002","value":"2.28","spread":"3.60"},{"groupId":"OG003","value":"2.64","spread":"4.29"}]}]},{"title":"Week 10 (N= 853, 844, 852, 846)","categories":[{"measurements":[{"groupId":"OG000","value":"2.29","spread":"3.89"},{"groupId":"OG001","value":"1.96","spread":"3.24"},{"groupId":"OG002","value":"2.33","spread":"3.80"},{"groupId":"OG003","value":"2.57","spread":"4.41"}]}]},{"title":"Week 12 (N= 772, 768, 750, 742)","categories":[{"measurements":[{"groupId":"OG000","value":"2.07","spread":"3.48"},{"groupId":"OG001","value":"1.83","spread":"3.21"},{"groupId":"OG002","value":"2.01","spread":"3.51"},{"groupId":"OG003","value":"2.46","spread":"4.10"}]}]},{"title":"Week 13 (N= 797, 796, 789, 807)","categories":[{"measurements":[{"groupId":"OG000","value":"2.11","spread":"3.74"},{"groupId":"OG001","value":"1.85","spread":"3.22"},{"groupId":"OG002","value":"2.01","spread":"3.47"},{"groupId":"OG003","value":"2.38","spread":"4.27"}]}]},{"title":"Week 16 (N= 784, 797, 775, 789)","categories":[{"measurements":[{"groupId":"OG000","value":"2.05","spread":"3.47"},{"groupId":"OG001","value":"1.90","spread":"3.43"},{"groupId":"OG002","value":"2.09","spread":"3.61"},{"groupId":"OG003","value":"2.34","spread":"3.98"}]}]},{"title":"Week 20 (N= 771, 785, 762, 772)","categories":[{"measurements":[{"groupId":"OG000","value":"2.10","spread":"3.54"},{"groupId":"OG001","value":"1.93","spread":"3.36"},{"groupId":"OG002","value":"1.97","spread":"3.53"},{"groupId":"OG003","value":"2.31","spread":"4.15"}]}]},{"title":"Week 24 (N= 758, 748, 737, 758)","categories":[{"measurements":[{"groupId":"OG000","value":"2.01","spread":"3.49"},{"groupId":"OG001","value":"1.87","spread":"3.47"},{"groupId":"OG002","value":"2.01","spread":"3.45"},{"groupId":"OG003","value":"2.25","spread":"4.04"}]}]}]},{"type":"SECONDARY","title":"HADS Total Score, Psychiatric History Cohort","description":"The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.","populationDescription":"The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"Baseline to Week 24","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1026"},{"groupId":"OG001","value":"1017"},{"groupId":"OG002","value":"1016"},{"groupId":"OG003","value":"1015"}]}],"classes":[{"title":"Week 1 (N= 1026, 1017, 1015, 1015)","categories":[{"measurements":[{"groupId":"OG000","value":"6.76","spread":"6.14"},{"groupId":"OG001","value":"7.58","spread":"6.87"},{"groupId":"OG002","value":"6.82","spread":"6.33"},{"groupId":"OG003","value":"6.70","spread":"5.94"}]}]},{"title":"Week 2 (N= 1005, 1004, 996, 995)","categories":[{"measurements":[{"groupId":"OG000","value":"6.42","spread":"6.36"},{"groupId":"OG001","value":"6.99","spread":"6.47"},{"groupId":"OG002","value":"6.64","spread":"6.55"},{"groupId":"OG003","value":"6.42","spread":"6.17"}]}]},{"title":"Week 3 (N= 947, 961, 945, 926)","categories":[{"measurements":[{"groupId":"OG000","value":"5.99","spread":"6.21"},{"groupId":"OG001","value":"6.51","spread":"6.39"},{"groupId":"OG002","value":"6.30","spread":"6.55"},{"groupId":"OG003","value":"6.02","spread":"6.10"}]}]},{"title":"Week 4 (N= 935, 938, 929, 908)","categories":[{"measurements":[{"groupId":"OG000","value":"5.87","spread":"6.39"},{"groupId":"OG001","value":"6.36","spread":"6.55"},{"groupId":"OG002","value":"6.16","spread":"6.51"},{"groupId":"OG003","value":"6.04","spread":"6.31"}]}]},{"title":"Week 5 (N= 918, 918, 914, 895)","categories":[{"measurements":[{"groupId":"OG000","value":"5.58","spread":"6.32"},{"groupId":"OG001","value":"6.03","spread":"6.41"},{"groupId":"OG002","value":"5.82","spread":"6.44"},{"groupId":"OG003","value":"5.80","spread":"6.31"}]}]},{"title":"Week 6 (N= 917, 914, 912, 874)","categories":[{"measurements":[{"groupId":"OG000","value":"5.39","spread":"6.14"},{"groupId":"OG001","value":"5.87","spread":"6.41"},{"groupId":"OG002","value":"5.62","spread":"6.22"},{"groupId":"OG003","value":"5.75","spread":"6.26"}]}]},{"title":"Week 8 (N= 887, 893, 878, 859)","categories":[{"measurements":[{"groupId":"OG000","value":"5.43","spread":"6.24"},{"groupId":"OG001","value":"5.96","spread":"6.68"},{"groupId":"OG002","value":"5.63","spread":"6.36"},{"groupId":"OG003","value":"5.63","spread":"6.26"}]}]},{"title":"Week 10 (N= 864, 865, 864, 823)","categories":[{"measurements":[{"groupId":"OG000","value":"5.38","spread":"6.35"},{"groupId":"OG001","value":"5.72","spread":"6.50"},{"groupId":"OG002","value":"5.64","spread":"6.30"},{"groupId":"OG003","value":"5.55","spread":"6.38"}]}]},{"title":"Week 12 (N= 790, 803, 798, 749)","categories":[{"measurements":[{"groupId":"OG000","value":"5.17","spread":"6.09"},{"groupId":"OG001","value":"5.66","spread":"6.63"},{"groupId":"OG002","value":"5.44","spread":"6.30"},{"groupId":"OG003","value":"5.42","spread":"6.13"}]}]},{"title":"Week 13 (N= 813, 812, 814, 763)","categories":[{"measurements":[{"groupId":"OG000","value":"5.06","spread":"6.11"},{"groupId":"OG001","value":"5.44","spread":"6.54"},{"groupId":"OG002","value":"5.36","spread":"6.20"},{"groupId":"OG003","value":"5.09","spread":"5.96"}]}]},{"title":"Week 16 (N= 795, 805, 791, 748)","categories":[{"measurements":[{"groupId":"OG000","value":"5.26","spread":"6.35"},{"groupId":"OG001","value":"5.62","spread":"6.68"},{"groupId":"OG002","value":"5.44","spread":"6.34"},{"groupId":"OG003","value":"5.37","spread":"6.38"}]}]},{"title":"Week 20 (N= 784, 784, 763, 737)","categories":[{"measurements":[{"groupId":"OG000","value":"5.17","spread":"6.02"},{"groupId":"OG001","value":"5.54","spread":"6.44"},{"groupId":"OG002","value":"5.46","spread":"6.18"},{"groupId":"OG003","value":"5.26","spread":"6.22"}]}]},{"title":"Week 24 (N= 770, 764, 758, 729)","categories":[{"measurements":[{"groupId":"OG000","value":"5.21","spread":"6.27"},{"groupId":"OG001","value":"5.69","spread":"6.64"},{"groupId":"OG002","value":"5.57","spread":"6.32"},{"groupId":"OG003","value":"5.04","spread":"5.97"}]}]}]},{"type":"SECONDARY","title":"HADS Total Score (Overall)","description":"The HADS is a subject self-reporting scale completed in person at clinic visits at Baseline and Weeks 1 through 6, 8, 10, 12, 13, 16, 20, and 24. It contains 14 individual item responses ranging in increasing severity from 0 (normal) to 3 (most severe) for a total range of 0 to 42. Of the 14 items, 7 assess anxiety and 7 assess depression, providing 2 subscales with ranges of 0 to 21. For each subscale, 0 to 7 is considered normal, while 15 to 21 represents severe symptoms.","populationDescription":"The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Units on a scale","timeFrame":"Baseline to Week 24","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2016"},{"groupId":"OG001","value":"2006"},{"groupId":"OG002","value":"2021"},{"groupId":"OG003","value":"2014"}]}],"classes":[{"title":"Week 1 (N= 1989, 1976, 1985, 1987)","categories":[{"measurements":[{"groupId":"OG000","value":"5.03","spread":"5.45"},{"groupId":"OG001","value":"5.61","spread":"6.07"},{"groupId":"OG002","value":"4.95","spread":"5.58"},{"groupId":"OG003","value":"5.05","spread":"5.41"}]}]},{"title":"Week 2 (N= 1938, 1937, 1931, 1929)","categories":[{"measurements":[{"groupId":"OG000","value":"4.68","spread":"5.55"},{"groupId":"OG001","value":"5.06","spread":"5.73"},{"groupId":"OG002","value":"4.74","spread":"5.70"},{"groupId":"OG003","value":"4.80","spread":"5.53"}]}]},{"title":"Week 3 (N= 1882, 1891, 1881, 1867)","categories":[{"measurements":[{"groupId":"OG000","value":"4.31","spread":"5.44"},{"groupId":"OG001","value":"4.60","spread":"5.63"},{"groupId":"OG002","value":"4.48","spread":"5.71"},{"groupId":"OG003","value":"4.38","spread":"5.37"}]}]},{"title":"Week 4 (N= 1858, 1854, 1863, 1831)","categories":[{"measurements":[{"groupId":"OG000","value":"4.15","spread":"5.50"},{"groupId":"OG001","value":"4.39","spread":"5.65"},{"groupId":"OG002","value":"4.31","spread":"5.64"},{"groupId":"OG003","value":"4.39","spread":"5.60"}]}]},{"title":"Week 5 (N= 1829, 1815, 1820, 1797)","categories":[{"measurements":[{"groupId":"OG000","value":"3.94","spread":"5.37"},{"groupId":"OG001","value":"4.16","spread":"5.52"},{"groupId":"OG002","value":"4.08","spread":"5.59"},{"groupId":"OG003","value":"4.14","spread":"5.51"}]}]},{"title":"Week 6 (N= 1816, 1807, 1821, 1771)","categories":[{"measurements":[{"groupId":"OG000","value":"3.82","spread":"5.27"},{"groupId":"OG001","value":"4.05","spread":"5.52"},{"groupId":"OG002","value":"4.01","spread":"5.42"},{"groupId":"OG003","value":"4.09","spread":"5.48"}]}]},{"title":"Week 8 (N= 1755, 1754, 1755, 1736)","categories":[{"measurements":[{"groupId":"OG000","value":"3.82","spread":"5.36"},{"groupId":"OG001","value":"4.10","spread":"5.75"},{"groupId":"OG002","value":"3.96","spread":"5.43"},{"groupId":"OG003","value":"4.12","spread":"5.56"}]}]},{"title":"Week 10 (N= 1717, 1709, 1716, 1669)","categories":[{"measurements":[{"groupId":"OG000","value":"3.85","spread":"5.49"},{"groupId":"OG001","value":"3.86","spread":"5.48"},{"groupId":"OG002","value":"4.00","spread":"5.47"},{"groupId":"OG003","value":"4.04","spread":"5.67"}]}]},{"title":"Week 12 (N= 1562, 1571, 1548, 1491)","categories":[{"measurements":[{"groupId":"OG000","value":"3.64","spread":"5.21"},{"groupId":"OG001","value":"3.79","spread":"5.58"},{"groupId":"OG002","value":"3.78","spread":"5.42"},{"groupId":"OG003","value":"3.95","spread":"5.42"}]}]},{"title":"Week 13 (N= 1610, 1608, 1603, 1570)","categories":[{"measurements":[{"groupId":"OG000","value":"3.60","spread":"5.29"},{"groupId":"OG001","value":"3.66","spread":"5.47"},{"groupId":"OG002","value":"3.71","spread":"5.32"},{"groupId":"OG003","value":"3.70","spread":"5.34"}]}]},{"title":"Week 16 (N= 1579, 1602, 1566, 1537)","categories":[{"measurements":[{"groupId":"OG000","value":"3.67","spread":"5.37"},{"groupId":"OG001","value":"3.77","spread":"5.63"},{"groupId":"OG002","value":"3.78","spread":"5.44"},{"groupId":"OG003","value":"3.82","spread":"5.50"}]}]},{"title":"Week 20 (N= 1555, 1569, 1525, 1509)","categories":[{"measurements":[{"groupId":"OG000","value":"3.65","spread":"5.18"},{"groupId":"OG001","value":"3.73","spread":"5.44"},{"groupId":"OG002","value":"3.72","spread":"5.33"},{"groupId":"OG003","value":"3.75","spread":"5.47"}]}]},{"title":"Week 24 (N= 1528, 1512, 1495, 1487)","categories":[{"measurements":[{"groupId":"OG000","value":"3.62","spread":"5.33"},{"groupId":"OG001","value":"3.80","spread":"5.64"},{"groupId":"OG002","value":"3.82","spread":"5.41"},{"groupId":"OG003","value":"3.62","spread":"5.27"}]}]}]},{"type":"SECONDARY","title":"Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Non-psychiatric History Cohort","description":"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from \"wish to be dead\" to \"active suicidal ideation with specific plan and intent\". Answers at screening are for lifetime history. Answers for all other visits are since last visit.The scale is also used to record any completed suicides.","populationDescription":"The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants with positive responses","timeFrame":"Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"990"},{"groupId":"OG001","value":"989"},{"groupId":"OG002","value":"1006"},{"groupId":"OG003","value":"999"}]}],"classes":[{"title":"Suicidal Behavior (Screening lifetime)","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"9"},{"groupId":"OG002","value":"7"},{"groupId":"OG003","value":"6"}]}]},{"title":"Suicidal Ideation (Screening lifetime)","categories":[{"measurements":[{"groupId":"OG000","value":"48"},{"groupId":"OG001","value":"43"},{"groupId":"OG002","value":"50"},{"groupId":"OG003","value":"49"}]}]},{"title":"Suicidal Behavior (Baseline)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"0"}]}]},{"title":"Suicidal Ideation (Baseline)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]},{"title":"Suicidal Behavior (treatment emergent 12 weeks)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"1"}]}]},{"title":"Suicidal Ideation (treatment emergent 12 weeks)","categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"4"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"6"}]}]}]},{"type":"SECONDARY","title":"Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Psychiatric History Cohort","description":"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from \"wish to be dead\" to \"active suicidal ideation with specific plan and intent\". Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides.","populationDescription":"The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants with positive responses","timeFrame":"Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1026"},{"groupId":"OG001","value":"1017"},{"groupId":"OG002","value":"1016"},{"groupId":"OG003","value":"1015"}]}],"classes":[{"title":"Suicidal Behavior (Screening lifetime)","categories":[{"measurements":[{"groupId":"OG000","value":"137"},{"groupId":"OG001","value":"143"},{"groupId":"OG002","value":"111"},{"groupId":"OG003","value":"123"}]}]},{"title":"Suicidal Ideation (Screening lifetime)","categories":[{"measurements":[{"groupId":"OG000","value":"338"},{"groupId":"OG001","value":"357"},{"groupId":"OG002","value":"333"},{"groupId":"OG003","value":"349"}]}]},{"title":"Suicidal Behavior (Baseline)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]},{"title":"Suicidal Ideation (Baseline)","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"3"}]}]},{"title":"Suicidal Behavior (treatment emergent 12 weeks)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"2"}]}]},{"title":"Suicidal Ideation (treatment emergent 12 weeks)","categories":[{"measurements":[{"groupId":"OG000","value":"27"},{"groupId":"OG001","value":"15"},{"groupId":"OG002","value":"20"},{"groupId":"OG003","value":"25"}]}]}]},{"type":"SECONDARY","title":"Positive Responses for Suicidal Behavior and/or Ideation by Columbia Suicide Severity Rating Scale (C-SSRS) - Overall","description":"The C-SSRS is a semi-structured interview designed to evaluate an individual's degree of suicidal ideation, preparatory acts or behavior to actual attempt, ranging from \"wish to be dead\" to \"active suicidal ideation with specific plan and intent\". Answers at screening are for lifetime history. Answers for all other visits are since last visit. The scale is also used to record any completed suicides.","populationDescription":"The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants with positive responses","timeFrame":"Lifetime, Baseline and Treatment-Emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2016"},{"groupId":"OG001","value":"2006"},{"groupId":"OG002","value":"2022"},{"groupId":"OG003","value":"2014"}]}],"classes":[{"title":"Suicidal Behavior (Screening lifetime)","categories":[{"measurements":[{"groupId":"OG000","value":"143"},{"groupId":"OG001","value":"152"},{"groupId":"OG002","value":"118"},{"groupId":"OG003","value":"129"}]}]},{"title":"Suicidal Ideation (Screening lifetime)","categories":[{"measurements":[{"groupId":"OG000","value":"386"},{"groupId":"OG001","value":"400"},{"groupId":"OG002","value":"383"},{"groupId":"OG003","value":"398"}]}]},{"title":"Suicidal Behavior (Baseline)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"},{"groupId":"OG003","value":"1"}]}]},{"title":"Suicidal Ideation (Baseline)","categories":[{"measurements":[{"groupId":"OG000","value":"6"},{"groupId":"OG001","value":"6"},{"groupId":"OG002","value":"2"},{"groupId":"OG003","value":"4"}]}]},{"title":"Suicidal Behavior (treatment emergent 12 weeks)","categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"1"},{"groupId":"OG002","value":"1"},{"groupId":"OG003","value":"3"}]}]},{"title":"Suicidal Ideation (treatment emergent 12 weeks)","categories":[{"measurements":[{"groupId":"OG000","value":"34"},{"groupId":"OG001","value":"19"},{"groupId":"OG002","value":"23"},{"groupId":"OG003","value":"31"}]}]}]},{"type":"SECONDARY","title":"Clinical Global Impression of Improvement (CGI-I), \"No Change\" Rating by Visit","description":"The CGI-I is a clinician rated instrument that measures change in participant's psychiatric condition (or lack thereof in the stratum without psychiatric disorders) on a 7 point scale ranging from 1 (very much improved) to 7 (very much worse), with 4 = no change. The ratings were applicable even to those without psychiatric diagnoses (eg, those with no psychiatric symptoms would be rated as \"normal, not at all ill\" on the CGI-S at baseline and assuming no psychiatric symptoms emerge during the trial, would be rated as \"no change\" on the CGI-I at follow-up visits). For those participants with a psychiatric diagnosis, the clinician should rate the severity of the mental illness with respect to the clinician's experience with the psychiatric population to which the participant belongs.","populationDescription":"The safety dataset included all participants who had received at least one partial dose of study medication (N=8058) and was used to analyze all safety endpoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline to Week 24","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2016"},{"groupId":"OG001","value":"2006"},{"groupId":"OG002","value":"2022"},{"groupId":"OG003","value":"2014"}]}],"classes":[{"title":"Week 1 (N= 1986, 1974, 1986, 1982)","categories":[{"measurements":[{"groupId":"OG000","value":"94.2"},{"groupId":"OG001","value":"93.2"},{"groupId":"OG002","value":"94.6"},{"groupId":"OG003","value":"95.1"}]}]},{"title":"Week 2 (N= 1934, 1936, 1927, 1926)","categories":[{"measurements":[{"groupId":"OG000","value":"90.8"},{"groupId":"OG001","value":"90.8"},{"groupId":"OG002","value":"90.5"},{"groupId":"OG003","value":"91.2"}]}]},{"title":"Week 3 (N= 1880, 1892, 1880, 1863)","categories":[{"measurements":[{"groupId":"OG000","value":"88.3"},{"groupId":"OG001","value":"89.8"},{"groupId":"OG002","value":"88.7"},{"groupId":"OG003","value":"87.9"}]}]},{"title":"Week 4 (N= 1860, 1856, 1858, 1834)","categories":[{"measurements":[{"groupId":"OG000","value":"86.6"},{"groupId":"OG001","value":"88.0"},{"groupId":"OG002","value":"87.1"},{"groupId":"OG003","value":"86.3"}]}]},{"title":"Week 5 (N= 1828, 1816, 1822, 1802)","categories":[{"measurements":[{"groupId":"OG000","value":"85.7"},{"groupId":"OG001","value":"86.5"},{"groupId":"OG002","value":"85.5"},{"groupId":"OG003","value":"85.4"}]}]},{"title":"Week 6 (N= 1816, 1808, 1820, 1773)","categories":[{"measurements":[{"groupId":"OG000","value":"85.2"},{"groupId":"OG001","value":"86.5"},{"groupId":"OG002","value":"85.1"},{"groupId":"OG003","value":"84.1"}]}]},{"title":"Week 8 (N= 1758, 1756, 1755, 1738)","categories":[{"measurements":[{"groupId":"OG000","value":"82.4"},{"groupId":"OG001","value":"83.6"},{"groupId":"OG002","value":"82.8"},{"groupId":"OG003","value":"81.9"}]}]},{"title":"Week 10 (N= 1717, 1707, 1715, 1675)","categories":[{"measurements":[{"groupId":"OG000","value":"80.6"},{"groupId":"OG001","value":"81.7"},{"groupId":"OG002","value":"80.4"},{"groupId":"OG003","value":"79.2"}]}]},{"title":"Week 12 (N= 1558, 1572, 1540, 1492)","categories":[{"measurements":[{"groupId":"OG000","value":"72.9"},{"groupId":"OG001","value":"75.1"},{"groupId":"OG002","value":"72.2"},{"groupId":"OG003","value":"71.3"}]}]},{"title":"Week 13 (N= 1612, 16081602, 1575)","categories":[{"measurements":[{"groupId":"OG000","value":"75.9"},{"groupId":"OG001","value":"76.7"},{"groupId":"OG002","value":"75.2"},{"groupId":"OG003","value":"74.9"}]}]},{"title":"Week 16 (N= 1586, 1606, 1568, 1541)","categories":[{"measurements":[{"groupId":"OG000","value":"74.2"},{"groupId":"OG001","value":"76.7"},{"groupId":"OG002","value":"73.9"},{"groupId":"OG003","value":"73.4"}]}]},{"title":"Week 20 (N= 1563, 1573, 1523, 1510)","categories":[{"measurements":[{"groupId":"OG000","value":"73.4"},{"groupId":"OG001","value":"75.0"},{"groupId":"OG002","value":"72.2"},{"groupId":"OG003","value":"71.7"}]}]},{"title":"Week 24 (N= 1533, 1515, 1499, 1497)","categories":[{"measurements":[{"groupId":"OG000","value":"71.8"},{"groupId":"OG001","value":"72.3"},{"groupId":"OG002","value":"71.1"},{"groupId":"OG003","value":"71.1"}]}]}]},{"type":"SECONDARY","title":"CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Non-psychiatric History Cohort","description":"A responder to this endpoint requires the answer \"no\" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).","populationDescription":"The full analysis set was defined under the intent-to-treat (ITT) principle as all randomized participants (N=8144) and was used for all efficacy endpoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 9 through Week 12","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1005"},{"groupId":"OG001","value":"1001"},{"groupId":"OG002","value":"1013"},{"groupId":"OG003","value":"1009"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"38.0"},{"groupId":"OG001","value":"26.1"},{"groupId":"OG002","value":"26.4"},{"groupId":"OG003","value":"13.7"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"groupDescription":"The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"No multiplicity adjustment.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"4.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.20","ciUpperLimit":"5.00"},{"groupIds":["OG001","OG003"],"groupDescription":"The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"No multiplicity adjustment.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.26","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.80","ciUpperLimit":"2.85"},{"groupIds":["OG002","OG003"],"groupDescription":"The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"No multiplicity adjustment.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.30","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.83","ciUpperLimit":"2.90"}]},{"type":"SECONDARY","title":"CO-Confirmed Continuous Abstinence for Weeks 9 Through 12, Psychiatric History Cohort","description":"A responder to this endpoint requires the answer \"no\" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).","populationDescription":"The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 9 through Week 12","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1032"},{"groupId":"OG001","value":"1033"},{"groupId":"OG002","value":"1025"},{"groupId":"OG003","value":"1026"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"29.2"},{"groupId":"OG001","value":"19.3"},{"groupId":"OG002","value":"20.4"},{"groupId":"OG003","value":"11.4"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"groupDescription":"The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"No multiplicity adjustment.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"3.24","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.56","ciUpperLimit":"4.11"},{"groupIds":["OG001","OG003"],"groupDescription":"The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"No multiplicity adjustment.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.87","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.46","ciUpperLimit":"2.39"},{"groupIds":["OG002","OG003"],"groupDescription":"The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"No multiplicity adjustment.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.56","ciUpperLimit":"2.55"}]},{"type":"SECONDARY","title":"CO-Confirmed Continuous Abstinence for Weeks 9 Through 12 (Overall)","description":"A responder to this endpoint requires the answer \"no\" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 12 (inclusive).","populationDescription":"The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 9 through Week 12","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2037"},{"groupId":"OG001","value":"2034"},{"groupId":"OG002","value":"2038"},{"groupId":"OG003","value":"2035"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"33.5"},{"groupId":"OG001","value":"22.6"},{"groupId":"OG002","value":"23.4"},{"groupId":"OG003","value":"12.5"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"groupDescription":"The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"No multiplicity adjustment.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"3.61","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"3.07","ciUpperLimit":"4.24"},{"groupIds":["OG001","OG003"],"groupDescription":"The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"No multiplicity adjustment.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.07","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.75","ciUpperLimit":"2.45"},{"groupIds":["OG002","OG003"],"groupDescription":"The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"No multiplicity adjustment.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.15","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.82","ciUpperLimit":"2.54"}]},{"type":"SECONDARY","title":"CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Non-psychiatric History Cohort","description":"A responder to this endpoint requires the answer \"no\" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).","populationDescription":"The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 9 through Week 24","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1005"},{"groupId":"OG001","value":"1001"},{"groupId":"OG002","value":"1013"},{"groupId":"OG003","value":"1009"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"25.5"},{"groupId":"OG001","value":"18.8"},{"groupId":"OG002","value":"18.5"},{"groupId":"OG003","value":"10.5"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"groupDescription":"The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"No multiplicity adjustment.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.99","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.33","ciUpperLimit":"3.83"},{"groupIds":["OG001","OG003"],"groupDescription":"The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"No multiplicity adjustment.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.00","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.54","ciUpperLimit":"2.59"},{"groupIds":["OG002","OG003"],"groupDescription":"The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"No multiplicity adjustment.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.96","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.51","ciUpperLimit":"2.54"}]},{"type":"SECONDARY","title":"CO-confirmed Continuous Abstinence From Week 9 Through Week 24, Psychiatric History Cohort","description":"A responder to this endpoint requires the answer \"no\" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).","populationDescription":"The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 9 through Week 24","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1032"},{"groupId":"OG001","value":"1033"},{"groupId":"OG002","value":"1025"},{"groupId":"OG003","value":"1026"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"18.3"},{"groupId":"OG001","value":"13.7"},{"groupId":"OG002","value":"13.0"},{"groupId":"OG003","value":"8.3"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"groupDescription":"The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"No multiplicity adjustment.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.50","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.90","ciUpperLimit":"3.29"},{"groupIds":["OG001","OG003"],"groupDescription":"The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"No multiplicity adjustment.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.77","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.33","ciUpperLimit":"2.36"},{"groupIds":["OG002","OG003"],"groupDescription":"The analysis was done using a logistic regression with terms treatment, cohort, region, treatment by cohort interaction, and region by cohort interaction. Region reduced to 2-level for consistency with primary safety model.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"No multiplicity adjustment.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.65","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.24","ciUpperLimit":"2.20"}]},{"type":"SECONDARY","title":"CO-confirmed Continuous Abstinence From Week 9 Through Week 24 (Overall)","description":"A responder to this endpoint requires the answer \"no\" to both questions 1 and 2 on the Nicotine Use Inventory at every visit from Week 9 to Week 24 (inclusive).","populationDescription":"The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Week 9 through Week 24","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2037"},{"groupId":"OG001","value":"2034"},{"groupId":"OG002","value":"2038"},{"groupId":"OG003","value":"2035"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"21.8"},{"groupId":"OG001","value":"16.2"},{"groupId":"OG002","value":"15.7"},{"groupId":"OG003","value":"9.4"}]}]}],"analyses":[{"groupIds":["OG000","OG003"],"groupDescription":"The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"No multiplicity adjustment.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"2.74","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"2.28","ciUpperLimit":"3.30"},{"groupIds":["OG001","OG003"],"groupDescription":"The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"No multiplicity adjustment.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.89","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.56","ciUpperLimit":"2.29"},{"groupIds":["OG002","OG003"],"groupDescription":"The analysis was done using a logistic regression with terms treatment and region. Region reduced to 2-level for consistency with primary safety model.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.0001","pValueComment":"No multiplicity adjustment.","statisticalMethod":"Regression, Logistic","paramType":"Odds Ratio (OR)","paramValue":"1.81","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"1.49","ciUpperLimit":"2.19"}]},{"type":"SECONDARY","title":"7-Day Point Prevalence of Abstinence, Non-psychiatric History Cohort","description":"A responder to this endpoint requires the answer \"no\" to both questions 3 and 6 on the nicotine use inventory at that specific visit.\n\nNUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?","populationDescription":"The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"24 Weeks","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1005"},{"groupId":"OG001","value":"1001"},{"groupId":"OG002","value":"1013"},{"groupId":"OG003","value":"1009"}]}],"classes":[{"title":"Week 1","categories":[{"measurements":[{"groupId":"OG000","value":"1.7"},{"groupId":"OG001","value":"1.0"},{"groupId":"OG002","value":"1.2"},{"groupId":"OG003","value":"1.5"}]}]},{"title":"Week 2","categories":[{"measurements":[{"groupId":"OG000","value":"20.9"},{"groupId":"OG001","value":"21.3"},{"groupId":"OG002","value":"15.5"},{"groupId":"OG003","value":"11.4"}]}]},{"title":"Week 3","categories":[{"measurements":[{"groupId":"OG000","value":"30.0"},{"groupId":"OG001","value":"26.6"},{"groupId":"OG002","value":"22.1"},{"groupId":"OG003","value":"13.6"}]}]},{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"34.3"},{"groupId":"OG001","value":"27.7"},{"groupId":"OG002","value":"25.9"},{"groupId":"OG003","value":"14.5"}]}]},{"title":"Week 5","categories":[{"measurements":[{"groupId":"OG000","value":"38.4"},{"groupId":"OG001","value":"29.8"},{"groupId":"OG002","value":"27.8"},{"groupId":"OG003","value":"14.9"}]}]},{"title":"Week 6","categories":[{"measurements":[{"groupId":"OG000","value":"41.0"},{"groupId":"OG001","value":"31.4"},{"groupId":"OG002","value":"30.4"},{"groupId":"OG003","value":"15.9"}]}]},{"title":"Week 7","categories":[{"measurements":[{"groupId":"OG000","value":"44.4"},{"groupId":"OG001","value":"35.2"},{"groupId":"OG002","value":"35.1"},{"groupId":"OG003","value":"19.2"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"42.3"},{"groupId":"OG001","value":"31.0"},{"groupId":"OG002","value":"31.4"},{"groupId":"OG003","value":"16.7"}]}]},{"title":"Week 9","categories":[{"measurements":[{"groupId":"OG000","value":"47.1"},{"groupId":"OG001","value":"34.9"},{"groupId":"OG002","value":"34.8"},{"groupId":"OG003","value":"19.0"}]}]},{"title":"Week 10","categories":[{"measurements":[{"groupId":"OG000","value":"42.4"},{"groupId":"OG001","value":"31.0"},{"groupId":"OG002","value":"31.1"},{"groupId":"OG003","value":"16.9"}]}]},{"title":"Week 11","categories":[{"measurements":[{"groupId":"OG000","value":"46.6"},{"groupId":"OG001","value":"34.1"},{"groupId":"OG002","value":"34.9"},{"groupId":"OG003","value":"20.8"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"44.4"},{"groupId":"OG001","value":"30.5"},{"groupId":"OG002","value":"30.4"},{"groupId":"OG003","value":"17.8"}]}]},{"title":"Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"41.1"},{"groupId":"OG001","value":"30.7"},{"groupId":"OG002","value":"29.9"},{"groupId":"OG003","value":"17.2"}]}]},{"title":"Week 14","categories":[{"measurements":[{"groupId":"OG000","value":"44.5"},{"groupId":"OG001","value":"33.5"},{"groupId":"OG002","value":"32.0"},{"groupId":"OG003","value":"20.4"}]}]},{"title":"Week 15","categories":[{"measurements":[{"groupId":"OG000","value":"43.8"},{"groupId":"OG001","value":"33.2"},{"groupId":"OG002","value":"32.4"},{"groupId":"OG003","value":"21.3"}]}]},{"title":"Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"37.2"},{"groupId":"OG001","value":"28.5"},{"groupId":"OG002","value":"28.1"},{"groupId":"OG003","value":"18.2"}]}]},{"title":"Week 17","categories":[{"measurements":[{"groupId":"OG000","value":"40.7"},{"groupId":"OG001","value":"31.9"},{"groupId":"OG002","value":"31.4"},{"groupId":"OG003","value":"20.1"}]}]},{"title":"Week 18","categories":[{"measurements":[{"groupId":"OG000","value":"40.9"},{"groupId":"OG001","value":"31.3"},{"groupId":"OG002","value":"31.7"},{"groupId":"OG003","value":"20.8"}]}]},{"title":"Week 19","categories":[{"measurements":[{"groupId":"OG000","value":"39.9"},{"groupId":"OG001","value":"31.2"},{"groupId":"OG002","value":"31.2"},{"groupId":"OG003","value":"20.8"}]}]},{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"35.1"},{"groupId":"OG001","value":"27.5"},{"groupId":"OG002","value":"26.3"},{"groupId":"OG003","value":"18.2"}]}]},{"title":"Week 21","categories":[{"measurements":[{"groupId":"OG000","value":"38.1"},{"groupId":"OG001","value":"30.3"},{"groupId":"OG002","value":"29.3"},{"groupId":"OG003","value":"20.1"}]}]},{"title":"Week 22","categories":[{"measurements":[{"groupId":"OG000","value":"38.7"},{"groupId":"OG001","value":"29.9"},{"groupId":"OG002","value":"29.0"},{"groupId":"OG003","value":"20.3"}]}]},{"title":"Week 23","categories":[{"measurements":[{"groupId":"OG000","value":"37.6"},{"groupId":"OG001","value":"30.6"},{"groupId":"OG002","value":"28.3"},{"groupId":"OG003","value":"20.3"}]}]},{"title":"Week 24","categories":[{"measurements":[{"groupId":"OG000","value":"33.6"},{"groupId":"OG001","value":"26.0"},{"groupId":"OG002","value":"27.0"},{"groupId":"OG003","value":"17.4"}]}]}]},{"type":"SECONDARY","title":"7-Day Point Prevalence of Abstinence, Psychiatric History Cohort","description":"A responder to this endpoint requires the answer \"no\" to both questions 3 and 6 on the nicotine use inventory at that specific visit.\n\nNUI Question 3 (Baseline through Week 24): Has the subject smoked any cigarettes (even a puff) in the last 7 days? NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?","populationDescription":"The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"24 Weeks","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"1032"},{"groupId":"OG001","value":"1033"},{"groupId":"OG002","value":"1025"},{"groupId":"OG003","value":"1026"}]}],"classes":[{"title":"Week 1","categories":[{"measurements":[{"groupId":"OG000","value":"1.0"},{"groupId":"OG001","value":"1.2"},{"groupId":"OG002","value":"0.7"},{"groupId":"OG003","value":"0.5"}]}]},{"title":"Week 2","categories":[{"measurements":[{"groupId":"OG000","value":"16.8"},{"groupId":"OG001","value":"14.6"},{"groupId":"OG002","value":"13.0"},{"groupId":"OG003","value":"9.2"}]}]},{"title":"Week 3","categories":[{"measurements":[{"groupId":"OG000","value":"22.7"},{"groupId":"OG001","value":"18.1"},{"groupId":"OG002","value":"17.9"},{"groupId":"OG003","value":"10.7"}]}]},{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"26.6"},{"groupId":"OG001","value":"21.3"},{"groupId":"OG002","value":"21.1"},{"groupId":"OG003","value":"11.8"}]}]},{"title":"Week 5","categories":[{"measurements":[{"groupId":"OG000","value":"28.5"},{"groupId":"OG001","value":"21.8"},{"groupId":"OG002","value":"22.4"},{"groupId":"OG003","value":"12.4"}]}]},{"title":"Week 6","categories":[{"measurements":[{"groupId":"OG000","value":"30.8"},{"groupId":"OG001","value":"22.7"},{"groupId":"OG002","value":"23.3"},{"groupId":"OG003","value":"13.4"}]}]},{"title":"Week 7","categories":[{"measurements":[{"groupId":"OG000","value":"34.8"},{"groupId":"OG001","value":"25.4"},{"groupId":"OG002","value":"27.5"},{"groupId":"OG003","value":"16.6"}]}]},{"title":"Week 8","categories":[{"measurements":[{"groupId":"OG000","value":"32.7"},{"groupId":"OG001","value":"22.1"},{"groupId":"OG002","value":"24.6"},{"groupId":"OG003","value":"15.0"}]}]},{"title":"Week 9","categories":[{"measurements":[{"groupId":"OG000","value":"36.2"},{"groupId":"OG001","value":"26.0"},{"groupId":"OG002","value":"29.4"},{"groupId":"OG003","value":"17.2"}]}]},{"title":"Week 10","categories":[{"measurements":[{"groupId":"OG000","value":"35.1"},{"groupId":"OG001","value":"24.3"},{"groupId":"OG002","value":"25.0"},{"groupId":"OG003","value":"14.0"}]}]},{"title":"Week 11","categories":[{"measurements":[{"groupId":"OG000","value":"38.6"},{"groupId":"OG001","value":"27.4"},{"groupId":"OG002","value":"29.4"},{"groupId":"OG003","value":"17.2"}]}]},{"title":"Week 12","categories":[{"measurements":[{"groupId":"OG000","value":"35.0"},{"groupId":"OG001","value":"23.9"},{"groupId":"OG002","value":"24.9"},{"groupId":"OG003","value":"14.2"}]}]},{"title":"Week 13","categories":[{"measurements":[{"groupId":"OG000","value":"32.7"},{"groupId":"OG001","value":"22.6"},{"groupId":"OG002","value":"24.0"},{"groupId":"OG003","value":"14.8"}]}]},{"title":"Week 14","categories":[{"measurements":[{"groupId":"OG000","value":"34.7"},{"groupId":"OG001","value":"25.0"},{"groupId":"OG002","value":"26.8"},{"groupId":"OG003","value":"17.8"}]}]},{"title":"Week 15","categories":[{"measurements":[{"groupId":"OG000","value":"33.4"},{"groupId":"OG001","value":"25.3"},{"groupId":"OG002","value":"26.0"},{"groupId":"OG003","value":"18.3"}]}]},{"title":"Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"29.1"},{"groupId":"OG001","value":"21.9"},{"groupId":"OG002","value":"21.8"},{"groupId":"OG003","value":"13.9"}]}]},{"title":"Week 17","categories":[{"measurements":[{"groupId":"OG000","value":"32.3"},{"groupId":"OG001","value":"24.0"},{"groupId":"OG002","value":"24.8"},{"groupId":"OG003","value":"17.4"}]}]},{"title":"Week 18","categories":[{"measurements":[{"groupId":"OG000","value":"31.7"},{"groupId":"OG001","value":"24.5"},{"groupId":"OG002","value":"24.7"},{"groupId":"OG003","value":"18.2"}]}]},{"title":"Week 19","categories":[{"measurements":[{"groupId":"OG000","value":"31.6"},{"groupId":"OG001","value":"24.7"},{"groupId":"OG002","value":"25.1"},{"groupId":"OG003","value":"17.6"}]}]},{"title":"Week 20","categories":[{"measurements":[{"groupId":"OG000","value":"26.6"},{"groupId":"OG001","value":"20.4"},{"groupId":"OG002","value":"25.1"},{"groupId":"OG003","value":"17.6"}]}]},{"title":"Week 21","categories":[{"measurements":[{"groupId":"OG000","value":"29.7"},{"groupId":"OG001","value":"23.2"},{"groupId":"OG002","value":"23.7"},{"groupId":"OG003","value":"17.5"}]}]},{"title":"Week 22","categories":[{"measurements":[{"groupId":"OG000","value":"29.1"},{"groupId":"OG001","value":"22.9"},{"groupId":"OG002","value":"23.6"},{"groupId":"OG003","value":"16.5"}]}]},{"title":"Week 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NUI Question 6 (Baseline through Week 12): Has the subject used any other nicotine containing products in the last 7 days? NUI Question 6 (Week 13 through Week 24): Has the subject used any other tobacco products in the last 7 days?","populationDescription":"The full analysis set was defined under the ITT principle as all randomized participants (N=8144) and was used for all efficacy endpoints.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"24 Weeks","groups":[{"id":"OG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication."},{"id":"OG001","title":"Bupropion 150 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication."},{"id":"OG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication."},{"id":"OG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2037"},{"groupId":"OG001","value":"2034"},{"groupId":"OG002","value":"2038"},{"groupId":"OG003","value":"2035"}]}],"classes":[{"title":"Week 1","categories":[{"measurements":[{"groupId":"OG000","value":"1.3"},{"groupId":"OG001","value":"1.1"},{"groupId":"OG002","value":"0.9"},{"groupId":"OG003","value":"1.0"}]}]},{"title":"Week 2","categories":[{"measurements":[{"groupId":"OG000","value":"18.8"},{"groupId":"OG001","value":"17.9"},{"groupId":"OG002","value":"14.2"},{"groupId":"OG003","value":"10.3"}]}]},{"title":"Week 3","categories":[{"measurements":[{"groupId":"OG000","value":"26.3"},{"groupId":"OG001","value":"22.3"},{"groupId":"OG002","value":"20.0"},{"groupId":"OG003","value":"12.1"}]}]},{"title":"Week 4","categories":[{"measurements":[{"groupId":"OG000","value":"30.4"},{"groupId":"OG001","value":"24.4"},{"groupId":"OG002","value":"23.5"},{"groupId":"OG003","value":"13.1"}]}]},{"title":"Week 5","categories":[{"measurements":[{"groupId":"OG000","value":"33.4"},{"groupId":"OG001","value":"25.7"},{"groupId":"OG002","value":"25.1"},{"groupId":"OG003","value":"13.6"}]}]},{"title":"Week 6","categories":[{"measurements":[{"groupId":"OG000","value":"35.8"},{"groupId":"OG001","value":"26.9"},{"groupId":"OG002","value":"26.8"},{"groupId":"OG003","value":"14.6"}]}]},{"title":"Week 7","categories":[{"measurements":[{"groupId":"OG000","value":"39.5"},{"groupId":"OG001","value":"30.2"},{"groupId":"OG002","value":"31.3"},{"groupId":"OG003","value":"17.9"}]}]},{"title":"Week 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13","categories":[{"measurements":[{"groupId":"OG000","value":"36.8"},{"groupId":"OG001","value":"26.5"},{"groupId":"OG002","value":"26.9"},{"groupId":"OG003","value":"16.0"}]}]},{"title":"Week 14","categories":[{"measurements":[{"groupId":"OG000","value":"39.5"},{"groupId":"OG001","value":"29.2"},{"groupId":"OG002","value":"29.4"},{"groupId":"OG003","value":"19.1"}]}]},{"title":"Week 15","categories":[{"measurements":[{"groupId":"OG000","value":"38.5"},{"groupId":"OG001","value":"29.2"},{"groupId":"OG002","value":"29.2"},{"groupId":"OG003","value":"19.8"}]}]},{"title":"Week 16","categories":[{"measurements":[{"groupId":"OG000","value":"33.1"},{"groupId":"OG001","value":"25.1"},{"groupId":"OG002","value":"24.9"},{"groupId":"OG003","value":"16.1"}]}]},{"title":"Week 17","categories":[{"measurements":[{"groupId":"OG000","value":"36.4"},{"groupId":"OG001","value":"27.9"},{"groupId":"OG002","value":"28.1"},{"groupId":"OG003","value":"18.8"}]}]},{"title":"Week 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Treatment emergent is first dose date to last dose date (up to 12 weeks) plus 30 days.","description":"AEs were reported from the time the informed consent was signed throughout the study including 30 days after the last dose of study medication. In addition to the the standard collection of volunteered and observed AEs, neuropsychiatric AEs of interest were solicited using the Neuropsychiatric Adverse Event Interview.","eventGroups":[{"id":"EG000","title":"Varenicline 1.0 mg BID","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.","seriousNumAffected":39,"seriousNumAtRisk":2016,"otherNumAffected":1158,"otherNumAtRisk":2016},{"id":"EG001","title":"Bupropion","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.","seriousNumAffected":48,"seriousNumAtRisk":2006,"otherNumAffected":1033,"otherNumAtRisk":2006},{"id":"EG002","title":"NRT Patch","description":"Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.","seriousNumAffected":45,"seriousNumAtRisk":2022,"otherNumAffected":1003,"otherNumAtRisk":2022},{"id":"EG003","title":"Placebo","description":"Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.","seriousNumAffected":41,"seriousNumAtRisk":2014,"otherNumAffected":884,"otherNumAtRisk":2014}],"seriousEvents":[{"term":"Acute myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (v18.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2016},{"groupId":"EG001","numAffected":0,"numAtRisk":2006},{"groupId":"EG002","numAffected":0,"numAtRisk":2022},{"groupId":"EG003","numAffected":1,"numAtRisk":2014}]},{"term":"Atrial fibrillation","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (v18.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2016},{"groupId":"EG001","numAffected":1,"numAtRisk":2006},{"groupId":"EG002","numAffected":4,"numAtRisk":2022},{"groupId":"EG003","numAffected":0,"numAtRisk":2014}]},{"term":"Cardiac failure","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (v18.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2016},{"groupId":"EG001","numAffected":0,"numAtRisk":2006},{"groupId":"EG002","numAffected":0,"numAtRisk":2022},{"groupId":"EG003","numAffected":1,"numAtRisk":2014}]},{"term":"Coronary artery disease","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (v18.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2016},{"groupId":"EG001","numAffected":1,"numAtRisk":2006},{"groupId":"EG002","numAffected":0,"numAtRisk":2022},{"groupId":"EG003","numAffected":0,"numAtRisk":2014}]},{"term":"Myocardial infarction","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (v18.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2016},{"groupId":"EG001","numAffected":0,"numAtRisk":2006},{"groupId":"EG002","numAffected":1,"numAtRisk":2022},{"groupId":"EG003","numAffected":1,"numAtRisk":2014}]},{"term":"Ulcerative keratitis","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (v18.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2016},{"groupId":"EG001","numAffected":0,"numAtRisk":2006},{"groupId":"EG002","numAffected":1,"numAtRisk":2022},{"groupId":"EG003","numAffected":0,"numAtRisk":2014}]},{"term":"Vitreous detachment","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (v18.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2016},{"groupId":"EG001","numAffected":0,"numAtRisk":2006},{"groupId":"EG002","numAffected":0,"numAtRisk":2022},{"groupId":"EG003","numAffected":0,"numAtRisk":2014}]},{"term":"Colitis ulcerative","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (v18.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2016},{"groupId":"EG001","numAffected":0,"numAtRisk":2006},{"groupId":"EG002","numAffected":1,"numAtRisk":2022},{"groupId":"EG003","numAffected":0,"numAtRisk":2014}]},{"term":"Diverticulum","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (v18.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2016},{"groupId":"EG001","numAffected":0,"numAtRisk":2006},{"groupId":"EG002","numAffected":0,"numAtRisk":2022},{"groupId":"EG003","numAffected":0,"numAtRisk":2014}]},{"term":"Gastritis","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (v18.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2016},{"groupId":"EG001","numAffected":1,"numAtRisk":2006},{"groupId":"EG002","numAffected":0,"numAtRisk":2022},{"groupId":"EG003","numAffected":1,"numAtRisk":2014}]},{"term":"Small intestinal obstruction","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (v18.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2016},{"groupId":"EG001","numAffected":0,"numAtRisk":2006},{"groupId":"EG002","numAffected":0,"numAtRisk":2022},{"groupId":"EG003","numAffected":1,"numAtRisk":2014}]},{"term":"Chest pain","organSystem":"General disorders","sourceVocabulary":"MedDRA (v18.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2016},{"groupId":"EG001","numAffected":0,"numAtRisk":2006},{"groupId":"EG002","numAffected":4,"numAtRisk":2022},{"groupId":"EG003","numAffected":2,"numAtRisk":2014}]},{"term":"Hernia","organSystem":"General disorders","sourceVocabulary":"MedDRA (v18.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2016},{"groupId":"EG001","numAffected":1,"numAtRisk":2006},{"groupId":"EG002","numAffected":0,"numAtRisk":2022},{"groupId":"EG003","numAffected":0,"numAtRisk":2014}]},{"term":"Bile duct stone","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 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(v18.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2016},{"groupId":"EG001","numAffected":0,"numAtRisk":2006},{"groupId":"EG002","numAffected":0,"numAtRisk":2022},{"groupId":"EG003","numAffected":1,"numAtRisk":2014}]},{"term":"Humerus fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (v18.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2016},{"groupId":"EG001","numAffected":0,"numAtRisk":2006},{"groupId":"EG002","numAffected":1,"numAtRisk":2022},{"groupId":"EG003","numAffected":0,"numAtRisk":2014}]},{"term":"Laceration","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (v18.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2016},{"groupId":"EG001","numAffected":0,"numAtRisk":2006},{"groupId":"EG002","numAffected":1,"numAtRisk":2022},{"groupId":"EG003","numAffected":0,"numAtRisk":2014}]},{"term":"Lower limb fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (v18.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2016},{"groupId":"EG001","numAffected":0,"numAtRisk":2006},{"groupId":"EG002","numAffected":0,"numAtRisk":2022},{"groupId":"EG003","numAffected":0,"numAtRisk":2014}]},{"term":"Road traffic accident","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (v18.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2016},{"groupId":"EG001","numAffected":1,"numAtRisk":2006},{"groupId":"EG002","numAffected":0,"numAtRisk":2022},{"groupId":"EG003","numAffected":0,"numAtRisk":2014}]},{"term":"Spinal fracture","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (v18.0)","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2016},{"groupId":"EG001","numAffected":0,"numAtRisk":2006},{"groupId":"EG002","numAffected":1,"numAtRisk":2022},{"groupId":"EG003","numAffected":0,"numAtRisk":2014}]},{"term":"Electrocardiogram abnormal","organSystem":"Investigations","sourceVocabulary":"MedDRA 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Investigator may not disclose previously undisclosed confidential other than study results."},"pointOfContact":{"title":"Pfizer ClinicalTrials.gov Call Center","organization":"Pfizer, Inc.","email":"ClinicalTrials.gov_Inquiries@pfizer.com","phone":"1-800-718-1021"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13","removedCountries":["France","Puerto Rico"]},"conditionBrowseModule":{"meshes":[{"id":"D016540","term":"Smoking Cessation"},{"id":"D001523","term":"Mental Disorders"}],"ancestors":[{"id":"D015438","term":"Health Behavior"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D000068580","term":"Varenicline"},{"id":"D016642","term":"Bupropion"}],"ancestors":[{"id":"D001552","term":"Benzazepines"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D011810","term":"Quinoxalines"},{"id":"D011427","term":"Propiophenones"},{"id":"D007659","term":"Ketones"},{"id":"D009930","term":"Organic Chemicals"}]}},"hasResults":true}