{"protocolSection":{"identificationModule":{"nctId":"NCT00285584","orgStudyIdInfo":{"id":"NIDA-15303-1"},"secondaryIdInfos":[{"id":"R01DA015303","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01DA015303"},{"id":"DPMC"}],"organization":{"fullName":"NYU Langone Health","class":"OTHER"},"briefTitle":"Bupropion For Reducing High-Risk Behaviors in Depressed Men Who Have Sex With Men (MSM)","officialTitle":"Drug Abuse, Depression and Responses to HIV Counseling"},"statusModule":{"statusVerifiedDate":"2017-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2002-09"},"primaryCompletionDateStruct":{"date":"2004-03","type":"ACTUAL"},"completionDateStruct":{"date":"2004-09","type":"ACTUAL"},"studyFirstSubmitDate":"2006-01-31","studyFirstSubmitQcDate":"2006-01-31","studyFirstPostDateStruct":{"date":"2006-02-02","type":"ESTIMATED"},"resultsFirstSubmitDate":"2012-03-13","resultsFirstSubmitQcDate":"2012-05-17","resultsFirstPostDateStruct":{"date":"2012-06-20","type":"ESTIMATED"},"lastUpdateSubmitDate":"2017-11-14","lastUpdatePostDateStruct":{"date":"2017-12-12","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"NYU Langone Health","class":"OTHER"},"collaborators":[{"name":"National Institute on Drug Abuse (NIDA)","class":"NIH"},{"name":"GlaxoSmithKline","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"The primary purpose of this study was to test the whether high-risk, HIV-seronegative persons with mild-to-moderate depression would be more likely to adopt protective behavior change when provided with pharmacotherapy for their depression than when treated with placebo. High-risk behaviors include using illegal drugs and participating in unprotected sexual intercourse. The specific pharmacotherapy used in this study was the anti-depressant, bupropion. The subject population consisted of HIV negative men who have sex with men (MSM) with mild-to-moderate depression.","detailedDescription":"Depression in men is often masked by high-risk behaviors such as alcohol and drug abuse. Common symptoms among depressed men include feelings of hopelessness and helplessness, irritability, and anger. MSM are among those at highest for HIV acquisition due to high-risk behaviors, including unprotected sexual intercourse and drug abuse. Bupropion is an antidepressant medication commonly used to treat depression. The purpose of this study thus was whether bupropion could help MSM with mild-to-moderate depression reduce their high-risk behaviors.\n\nParticipants in this trial were randomly assigned to receive either bupropion or placebo for 6 months. Study visits lasting approximately 2 hours each occurred at Day 0, and at Months 4, 6, and 9; included in these visits were physical examination, testing for HIV and sexually transmitted disease (STD), depression screening, and an interview-administered questionnaire inquiring into sexual activity and drug use. Shorter study visits, lasting 15 - 30 minutes each occurred at Day 15, and Months 1, 2, 4, 5, and 7, and included depression screening and physical exam."},"conditionsModule":{"conditions":["HIV Infections","Depression"],"keywords":["HIV infection","Depression","Men who have sex with men","Drug abuse"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"PREVENTION","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":41,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Bupropion","type":"ACTIVE_COMPARATOR","description":"Participants in this arm received bupropion.","interventionNames":["Drug: Bupropion"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Participants in this arm received placebo that looked identical to the active comparator medication.","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Bupropion","description":"Participants initially received bupropion, 150 mg, once daily, to be taken in the morning. Dosage was increased to 150 mg twice daily within one month. Return visits were conducted monthly from study Months 1 through 6 to review medication dosage, ascertain side effects and evaluate depression severity. At the end of Moth 6, subjects were tapered to 150 mg/day over a period of 4 - 7 days. The final 150 mg/day dosage of bupropion allowed referral for pharmacotherapy without unblinding subjects or staff regarding bupropion/placebo assignment. Subjects were followed through Month 9 to permit evaluation of the durability of intervention effects.","armGroupLabels":["Bupropion"],"otherNames":["Brand name of bupropion used in the trial: Wellbutrin SR"]},{"type":"DRUG","name":"Placebo","description":"Participants initially received placebo, 150 mg, once daily, to be taken in the morning. Dosage was increased to 150 mg twice daily within one month. Return visits were conducted monthly from study Months 1 through 6 to review medication dosage, ascertain side effects and evaluate depression severity. At the end of Moth 6, subjects were tapered to 150 mg/day over a period of 4 - 7 days. The final 150 mg/day dosage allowed referral for pharmacotherapy without unblinding subjects or staff regarding bupropion/placebo assignment. Subjects were followed through Month 9 to permit evaluation of the durability of intervention effects.","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment.","description":"The self-reported number of partners in unprotected anal intercourse during the 3 months prior to interview as reported at the Month 6 visit minus reported at the enrollment visit.","timeFrame":"Enrollment to Month 6"}],"secondaryOutcomes":[{"measure":"Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire.","description":"Within-individual changes in the frequency of use of recreational drugs per month in the 3 months prior to interview reported at the Month 6 visit minus that reported at the enrollment visit.","timeFrame":"Month 6 compared to Month 0 (enrollment)"},{"measure":"Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing)","description":"Number of participants with incident sexually transmitted disease between enrollment the Month 6 interview.","timeFrame":"Enrollment to Month 6"},{"measure":"Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6.","description":"The BDI-II is a self-administered, multiple-choice questionnaire inquiring into the presence and severity of symptoms associated with depression. BDI-II scores range from 0 to 63, with 10-19 interpreted as mild-to-moderate; 20-29 as moderate-to-severe, and ≥ 30 as severe depression. The study outcome measure was the BDI-II score at Month 6 minus the BDI score at enrollment","timeFrame":"Month 6 compared to enrollment (Month 0)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Available for at least 9 months, or the duration of the study\n* Willing to complete HIV testing and counseling\n* History of HIV testing and counseling\n* At high risk of HIV infection, indicated by more than one male sexual partner in the 3 months prior to study entry\n* Meets criteria for either (a) major depression or dysthymia within a mild-to-moderate level according to standard criteria DSM-IV, or (b) minor depression as defined by one or more of the following symptoms at any time and for any duration during the past 12 months: significant weight loss or gain, or significant decrease or increase in appetite; poor sleep pattern; noticeable irritability or slowness; fatigue or lack of energy; inappropriate feelings of worthlessness or guilt; inability to concentrate; indecisiveness; and recurrent thoughts of death or suicide.\n\nExclusion Criteria:\n\n* HIV infected\n* Sexual intercourse in the 3 months prior to study entry with only one partner, and in a monogamous relationship\n* Currently enrolled in another study involving repeated HIV testing and counseling\n* Receiving treatment for depression with antidepressant medication for any length of time within the year prior to study entry\n* Currently in psychotherapy, psychoanalysis, or any other form of talk therapy for any reason\n* Severe depression or at suicidal risk\n* No evidence or prior history of depression\n* Homicidal or other similar problem that, in the opinion of the investigator, may endanger study staff and participants\n* Currently taking monoamine oxidase inhibitors (MAOIs). Participants may be allowed to enroll 14 days after discontinuing use of a MAOI.\n* History of seizures\n* History or current symptoms of bipolar disorder","healthyVolunteers":false,"sex":"MALE","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Michael Marmor, PhD","affiliation":"Department of Environmental Medicine, New York University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Bellevue Hospital Center","city":"New York","state":"New York","zip":"10016-3240","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"New York University School of Medicine","city":"New York","state":"New York","zip":"10016-3240","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}}]},"referencesModule":{"references":[{"pmid":"16954729","type":"BACKGROUND","citation":"Thomas SM, Tse DB, Ketner DS, Rochford G, Meyer DA, Zade DD, Halkitis PN, Nadas A, Borkowsky W, Marmor M. CCR5 expression and duration of high risk sexual activity among HIV-seronegative men who have sex with men. AIDS. 2006 Sep 11;20(14):1879-83. doi: 10.1097/01.aids.0000244207.49123.ff."},{"pmid":"16736351","type":"BACKGROUND","citation":"Marmor M, Hertzmark K, Thomas SM, Halkitis PN, Vogler M. Resistance to HIV infection. J Urban Health. 2006 Jan;83(1):5-17. doi: 10.1007/s11524-005-9003-8."},{"pmid":"15491956","type":"BACKGROUND","citation":"Halkitis PN, Zade DD, Shrem M, Marmor M. Beliefs about HIV non-infection and risky sexual behavior among MSM. AIDS Educ Prev. 2004 Oct;16(5):448-58. doi: 10.1521/aeap.16.5.448.48739."},{"pmid":"15135709","type":"BACKGROUND","citation":"Marmor M, Penn A, Widmer K, Levin RI, Maslansky R. Coronary artery disease and opioid use. Am J Cardiol. 2004 May 15;93(10):1295-7. doi: 10.1016/j.amjcard.2004.01.072."}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"Recruitment: Sept. 2002 - March 2004. High-risk, HIV-seronegative, New York City men who have sex with men (MSM) were informed of the study by field workers at MSM-oriented bars, clubs and community events; advertisements in magazines distributed at such venues; and e-mails to persons offering sexual services for MSM on the Internet.","groups":[{"id":"FG000","title":"Bupropion","description":"Participants in this arm received bupropion."},{"id":"FG001","title":"Placebo","description":"Participants in this arm received placebo."}],"periods":[{"title":"Enrollment (Month 0)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"21"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"21"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Month 3","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"20"},{"groupId":"FG001","numSubjects":"21"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"18"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"3"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Month 6","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"18"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"17"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}]},{"title":"Month 9","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"16"},{"groupId":"FG001","numSubjects":"17"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"14"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"3"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Bupropion","description":"Participants in this arm received bupropion."},{"id":"BG001","title":"Placebo","description":"Participants in this arm received placebo."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"41"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEDIAN","dispersionType":"FULL_RANGE","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"32.5","lowerLimit":"23","upperLimit":"48"},{"groupId":"BG001","value":"32","lowerLimit":"20","upperLimit":"48"},{"groupId":"BG002","value":"32","lowerLimit":"20","upperLimit":"48"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"41"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"7"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"18"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"34"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"3"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"10"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"16"},{"groupId":"BG002","value":"26"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"2"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"41"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"The Number of Sexual Partners in Unprotected Anal Intercourse Reported at 6 Months Minus the Number Reported at Enrollment.","description":"The self-reported number of partners in unprotected anal intercourse during the 3 months prior to interview as reported at the Month 6 visit minus reported at the enrollment visit.","populationDescription":"Subjects remaining in study through 6-Month study visit.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"Sexual partners","timeFrame":"Enrollment to Month 6","groups":[{"id":"OG000","title":"Bupropion","description":"6 months"},{"id":"OG001","title":"Placebo","description":"6 months"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-2.5","lowerLimit":"-50","upperLimit":"0"},{"groupId":"OG001","value":"-4","lowerLimit":"-10","upperLimit":"4"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.9","statisticalMethod":"Wilcoxon (Mann-Whitney)","paramType":"Median Difference (Final Values)","paramValue":"1.5"}]},{"type":"SECONDARY","title":"Change in the Frequency Per Month of Use of Recreational Drugs Between Enrollment and Month 6 Measured by Questionnaire.","description":"Within-individual changes in the frequency of use of recreational drugs per month in the 3 months prior to interview reported at the Month 6 visit minus that reported at the enrollment visit.","populationDescription":"All subjects who were randomized, met study inclusion/exclusion criteria and were followed through Month 6","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"Drug-using occasions per month","timeFrame":"Month 6 compared to Month 0 (enrollment)","groups":[{"id":"OG000","title":"Bupropion"},{"id":"OG001","title":"Placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.5","lowerLimit":"-7.5","upperLimit":"23"},{"groupId":"OG001","value":"0","lowerLimit":"-15","upperLimit":"15"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Wilcoxon rank test","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.3","statisticalMethod":"Wilcoxon (Mann-Whitney)","paramType":"Median Difference (Net)","paramValue":"0.5"}]},{"type":"SECONDARY","title":"Incidence of Sexually Transmitted Infections Between Study Entry and Month 6 (Measured by Questionnaire and Laboratory Testing)","description":"Number of participants with incident sexually transmitted disease between enrollment the Month 6 interview.","populationDescription":"Self-reported and laboratory identified sexually transmitted infections","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"participants","timeFrame":"Enrollment to Month 6","groups":[{"id":"OG000","title":"Bupropion","description":"Participants in this arm received bupropion."},{"id":"OG001","title":"Placebo","description":"Participants in this arm received placebo."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"20"},{"groupId":"OG001","value":"21"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"1"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Comparison of cumulative incidence proportions","nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.3","statisticalMethod":"Fisher Exact","paramType":"Risk Ratio (RR)","paramValue":"3.15","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"0.4","ciUpperLimit":"27.8"}]},{"type":"SECONDARY","title":"Change in Beck Depression Inventory - II (BDI-II) Scores Between Enrollment and Month 6.","description":"The BDI-II is a self-administered, multiple-choice questionnaire inquiring into the presence and severity of symptoms associated with depression. BDI-II scores range from 0 to 63, with 10-19 interpreted as mild-to-moderate; 20-29 as moderate-to-severe, and ≥ 30 as severe depression. The study outcome measure was the BDI-II score at Month 6 minus the BDI score at enrollment","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Full Range","unitOfMeasure":"units on a scale","timeFrame":"Month 6 compared to enrollment (Month 0)","groups":[{"id":"OG000","title":"Bupropion"},{"id":"OG001","title":"Placebo"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"16"},{"groupId":"OG001","value":"17"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-11.5","lowerLimit":"-31","upperLimit":"8"},{"groupId":"OG001","value":"-9","lowerLimit":"-19","upperLimit":"5"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.19","statisticalMethod":"Wilcoxon (Mann-Whitney)","paramType":"Median Difference (Final Values)","paramValue":"-2.5"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From enrollment through the 9-month follow-up.","eventGroups":[{"id":"EG000","title":"Bupropion","description":"Participants in this arm received bupropion.","seriousNumAffected":1,"seriousNumAtRisk":20,"otherNumAffected":18,"otherNumAtRisk":20},{"id":"EG001","title":"Placebo","description":"Participants in this arm received placebo.","seriousNumAffected":0,"seriousNumAtRisk":21,"otherNumAffected":18,"otherNumAtRisk":21}],"seriousEvents":[{"term":"Hospitalization with acute HIV infection","organSystem":"Infections and infestations","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Note that both SAEs occurred in a single individual enrolled in the bupropion arm of the study.","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":20},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":21}]},{"term":"Hospitalization with left-sided chest pain radiating the left arm","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Note that both SAEs occurred in a single individual enrolled in the bupropion arm of the study.","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":20},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":21}]}],"otherEvents":[{"term":"Elevated diastolic pressure (>= 80 mm Hg) at Months 3, 6 or 9","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":16,"numAffected":10,"numAtRisk":16},{"groupId":"EG001","numEvents":10,"numAffected":6,"numAtRisk":14}]},{"term":"Elevated systolic pressure (>= 140 mm Hg) at Months 3, 6 or 9","organSystem":"Cardiac disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":16},{"groupId":"EG001","numEvents":4,"numAffected":3,"numAtRisk":17}]},{"term":"Weight loss","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":21}]},{"term":"Dry mouth","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":8,"numAffected":5,"numAtRisk":20},{"groupId":"EG001","numEvents":4,"numAffected":4,"numAtRisk":21}]},{"term":"Diarrhea","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":6,"numAffected":4,"numAtRisk":20},{"groupId":"EG001","numEvents":8,"numAffected":5,"numAtRisk":21}]},{"term":"Insomnia","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":11,"numAffected":7,"numAtRisk":20},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":21}]},{"term":"Headache","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":10,"numAffected":6,"numAtRisk":20},{"groupId":"EG001","numEvents":6,"numAffected":4,"numAtRisk":21}]},{"term":"Dizziness","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":20},{"groupId":"EG001","numEvents":4,"numAffected":2,"numAtRisk":21}]},{"term":"Agitation","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":20},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":21}]},{"term":"Somnolence","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":20},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":21}]},{"term":"Fatigue","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":5,"numAffected":5,"numAtRisk":20},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":21}]},{"term":"Pharyngitis","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":8,"numAffected":6,"numAtRisk":20},{"groupId":"EG001","numEvents":11,"numAffected":5,"numAtRisk":21}]},{"term":"Sinus problem","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":4,"numAffected":3,"numAtRisk":20},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":21}]},{"term":"Cough","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":20},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":21}]},{"term":"Nasal congestion","organSystem":"Respiratory, thoracic and mediastinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":20},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":21}]},{"term":"Rash","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":7,"numAffected":3,"numAtRisk":20},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":21}]},{"term":"Excessive sweating","organSystem":"Skin and subcutaneous tissue disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":20},{"groupId":"EG001","numEvents":3,"numAffected":2,"numAtRisk":21}]},{"term":"Fever","organSystem":"Infections and infestations","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":20},{"groupId":"EG001","numEvents":2,"numAffected":2,"numAtRisk":21}]},{"term":"Chlamydia trachomatis infection","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":20},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":21}]},{"term":"Streptococcal infection of throat","organSystem":"Infections and infestations","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numEvents":2,"numAffected":2,"numAtRisk":20},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":21}]},{"term":"Upper 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