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No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123. This study is an extension protocol for study A3051123. No treatment is provided during this study. This study is to monitor for cardiovascular events 28 weeks after completion of A3051123."},"conditionsModule":{"conditions":["Smoking Cessation"],"keywords":["smoking cessation","psychiatric disease","cardiovascular events"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"SINGLE_GROUP","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":4595,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"placebo","type":"EXPERIMENTAL","interventionNames":["Drug: placebo"]},{"label":"varenicline","type":"EXPERIMENTAL","interventionNames":["Drug: varenicline tartrate"]},{"label":"bupropion","type":"EXPERIMENTAL","interventionNames":["Drug: bupropion hydrochloride"]},{"label":"Nicotine Replacement Therapy Patch","type":"EXPERIMENTAL","interventionNames":["Drug: Nicotine Replacement Therapy Patch"]}],"interventions":[{"type":"DRUG","name":"placebo","description":"All dosing to have taken place per study A3051123","armGroupLabels":["placebo"]},{"type":"DRUG","name":"varenicline tartrate","description":"All dosing to have taken place per study A3051123","armGroupLabels":["varenicline"],"otherNames":["Chantix; Champix"]},{"type":"DRUG","name":"bupropion hydrochloride","description":"All dosing to have taken place per study A3051123","armGroupLabels":["bupropion"],"otherNames":["Zyban"]},{"type":"DRUG","name":"Nicotine Replacement Therapy Patch","description":"All dosing to have taken place per study A3051123","armGroupLabels":["Nicotine Replacement Therapy Patch"],"otherNames":["NRT"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.","description":"This is an adjudicated endpoint. 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The measure type mentioned in the outcome data table is Hazard Ratio.","timeFrame":"Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days."},{"measure":"Time to MACE Until the End of Study NCT01574703.","description":"This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study. The measure type mentioned in the outcome data table is Hazard Ratio.","timeFrame":"Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703)."},{"measure":"Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.","description":"This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug).","timeFrame":"Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks)."},{"measure":"Incidence of MACE + Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.","description":"This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening peripheral vascular disease (PVD) requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.","timeFrame":"Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks)."},{"measure":"Incidence of MACE Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.","description":"This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up.","timeFrame":"Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up."},{"measure":"Incidence of MACE+ Assessed up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.","description":"This is an adjudicated endpoint. MACE + is defined as any MACE or a new onset or worsening PVD requiring intervention, a need for coronary revascularization, or hospitalization for unstable angina.","timeFrame":"Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days follow-up."},{"measure":"Incidence of MACE Assessed Until End of Study NCT01574703.","description":"This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated until end of study.","timeFrame":"Baseline until end of study (end of study is defined as last visit in study NCT01574703 [up to Week 52], or in study NCT01456936 [up to 24 Weeks] for those participants not enrolled into study NCT01574703)."},{"measure":"Incidence of MACE+ Assessed Until End of Study NCT01574703.","description":"This is an adjudicated endpoint. 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Cardiovascular Safety of Varenicline, Bupropion, and Nicotine Patch in Smokers: A Randomized Clinical Trial. JAMA Intern Med. 2018 May 1;178(5):622-631. doi: 10.1001/jamainternmed.2018.0397."}],"seeAlsoLinks":[{"label":"To obtain contact information for a study center near you, click here.","url":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3051148&StudyName=Study%20To%20Evaluate%20Cardiac%20Assessments%20Following%20Different%20Treatments%20Of%20Smoking%20Cessation%20Medications%20In%20Subjects%20With%20And%20without%20Psychiatr"}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"This is a non-treatment extension study of parent study NCT01456936. No study drug was provided in this extension phase. However, cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline(N=2016), bupropion(N=2006),NRT(N=2022), or placebo(N=2014) in a triple-dummy design were analyzed in this study.","recruitmentDetails":"Of the 6293 participants who completed the parent study NCT01456936 as per protocol, a total of 4595 participants enrolled into this study NCT01574703 from 132 centers in 16 countries.","groups":[{"id":"FG000","title":"Varenicline","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study."},{"id":"FG001","title":"Bupropion","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study."},{"id":"FG002","title":"Nicotine Replacement Therapy (NRT) Patch","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study."},{"id":"FG003","title":"Placebo","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"1192"},{"groupId":"FG001","numSubjects":"1166"},{"groupId":"FG002","numSubjects":"1116"},{"groupId":"FG003","numSubjects":"1121"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1067"},{"groupId":"FG001","numSubjects":"1054"},{"groupId":"FG002","numSubjects":"1011"},{"groupId":"FG003","numSubjects":"1007"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"125"},{"groupId":"FG001","numSubjects":"112"},{"groupId":"FG002","numSubjects":"105"},{"groupId":"FG003","numSubjects":"114"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Protocol Violation","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}]},{"type":"Unspecified Reason","reasons":[{"groupId":"FG000","numSubjects":"27"},{"groupId":"FG001","numSubjects":"15"},{"groupId":"FG002","numSubjects":"20"},{"groupId":"FG003","numSubjects":"16"}]},{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"53"},{"groupId":"FG001","numSubjects":"52"},{"groupId":"FG002","numSubjects":"36"},{"groupId":"FG003","numSubjects":"61"}]},{"type":"Met Withdrawal Criteria","reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"41"},{"groupId":"FG002","numSubjects":"46"},{"groupId":"FG003","numSubjects":"35"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"The term Baseline visit refers to the Baseline (Week 0) visit of the parent study NCT01456936. The safety population included all participants who received at least one dose of study drug in NCT01456936 parent study. The below Baseline characteristics (age, gender) are presented for all participants who entered study NCT01574703.","groups":[{"id":"BG000","title":"Varenicline","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study."},{"id":"BG001","title":"Bupropion","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study."},{"id":"BG002","title":"NRT Patch","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study."},{"id":"BG003","title":"Placebo","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"1192"},{"groupId":"BG001","value":"1166"},{"groupId":"BG002","value":"1116"},{"groupId":"BG003","value":"1121"},{"groupId":"BG004","value":"4595"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"Years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"48.1","spread":"12.2"},{"groupId":"BG001","value":"47.7","spread":"12.5"},{"groupId":"BG002","value":"48.3","spread":"11.9"},{"groupId":"BG003","value":"47.5","spread":"12.2"},{"groupId":"BG004","value":"47.9","spread":"12.2"}]}]}]},{"title":"Gender","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"659"},{"groupId":"BG001","value":"648"},{"groupId":"BG002","value":"623"},{"groupId":"BG003","value":"621"},{"groupId":"BG004","value":"2551"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"533"},{"groupId":"BG001","value":"518"},{"groupId":"BG002","value":"493"},{"groupId":"BG003","value":"500"},{"groupId":"BG004","value":"2044"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Time to Occurrence of Major Adverse Cardiovascular Event (MACE) During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.","description":"This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug). The measure type mentioned in the outcome data table is Hazard Ratio relative to Placebo.","populationDescription":"The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.","reportingStatus":"POSTED","paramType":"NUMBER","dispersionType":"95% Confidence Interval","unitOfMeasure":"Unitless","timeFrame":"Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).","groups":[{"id":"OG000","title":"Varenicline","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study."},{"id":"OG001","title":"Bupropion","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study."},{"id":"OG002","title":"NRT Patch","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study."},{"id":"OG003","title":"Placebo","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2016"},{"groupId":"OG001","value":"2006"},{"groupId":"OG002","value":"2022"},{"groupId":"OG003","value":"2014"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.29","lowerLimit":"0.05","upperLimit":"1.68"},{"groupId":"OG001","value":"0.50","lowerLimit":"0.10","upperLimit":"2.50"},{"groupId":"OG002","value":"0.29","lowerLimit":"0.05","upperLimit":"1.70"},{"groupId":"OG003","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Hazard ratio relative to Placebo."}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003"],"groupDescription":"Statistical analysis for overall treatment comparison.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.37","pValueComment":"P-value for the treatment effect from the Log-Rank test stratified by Cohort.","statisticalMethod":"Log Rank"}]},{"type":"SECONDARY","title":"Time to MACE up to Date of Last Dose of Study Drug Plus 30 Days Follow-up in Study NCT01456936.","description":"This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug) plus 30 days follow-up. The measure type mentioned in the outcome data table is Hazard Ratio.","populationDescription":"The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.","reportingStatus":"POSTED","paramType":"NUMBER","dispersionType":"95% Confidence Interval","unitOfMeasure":"Unitless","timeFrame":"Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks) plus 30 days.","groups":[{"id":"OG000","title":"Varenicline","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study."},{"id":"OG001","title":"Bupropion","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study."},{"id":"OG002","title":"NRT Patch","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study."},{"id":"OG003","title":"Placebo","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2016"},{"groupId":"OG001","value":"2006"},{"groupId":"OG002","value":"2022"},{"groupId":"OG003","value":"2014"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.29","lowerLimit":"0.05","upperLimit":"1.70"},{"groupId":"OG001","value":"0.51","lowerLimit":"0.10","upperLimit":"2.51"},{"groupId":"OG002","value":"0.50","lowerLimit":"0.10","upperLimit":"2.48"},{"groupId":"OG003","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Hazard ratio relative to Placebo."}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003"],"groupDescription":"Statistical analysis for overall treatment comparison.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.53","pValueComment":"P-value for the treatment effect from the Log-Rank test stratified by Cohort.","statisticalMethod":"Log Rank"}]},{"type":"SECONDARY","title":"Time to MACE Until the End of Study NCT01574703.","description":"This is an adjudicated endpoint. 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However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study."},{"id":"OG001","title":"Bupropion","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study."},{"id":"OG002","title":"NRT Patch","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study."},{"id":"OG003","title":"Placebo","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2016"},{"groupId":"OG001","value":"2006"},{"groupId":"OG002","value":"2022"},{"groupId":"OG003","value":"2014"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.39","lowerLimit":"0.12","upperLimit":"1.27"},{"groupId":"OG001","value":"1.09","lowerLimit":"0.42","upperLimit":"2.83"},{"groupId":"OG002","value":"0.75","lowerLimit":"0.26","upperLimit":"2.13"},{"groupId":"OG003","value":"NA","lowerLimit":"NA","upperLimit":"NA","comment":"Hazard ratio relative to Placebo."}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003"],"groupDescription":"Statistical analysis for overall treatment comparison.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.34","pValueComment":"P-value for the treatment effect from the Log-Rank test stratified by Cohort.","statisticalMethod":"Log Rank"}]},{"type":"SECONDARY","title":"Incidence of MACE Assessed During Treatment Period (up to Date of Last Dose of Study Drug) in Study NCT01456936.","description":"This is an adjudicated endpoint. MACE is defined as a cardiovascular death, a non-fatal myocardial infarction or a non-fatal stroke evaluated during the treatment phase (up to date of last dose of study drug).","populationDescription":"The safety analysis set is defined as all participants that received at least one partial dose of study drug during the parent study NCT01456936.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of participants","timeFrame":"Baseline to last dose of study drug in parent study NCT01456936 (up to 12 weeks).","groups":[{"id":"OG000","title":"Varenicline","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study."},{"id":"OG001","title":"Bupropion","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study."},{"id":"OG002","title":"NRT Patch","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study."},{"id":"OG003","title":"Placebo","description":"This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. 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However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"2016"},{"groupId":"OG001","value":"2006"},{"groupId":"OG002","value":"2022"},{"groupId":"OG003","value":"2014"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.50"},{"groupId":"OG001","value":"0.75"},{"groupId":"OG002","value":"0.49"},{"groupId":"OG003","value":"0.60"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"Statistical analysis between Varenicline and Bupropion.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6105","pValueComment":"P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"-0.59","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.84","ciUpperLimit":"1.67"},{"groupIds":["OG000","OG002"],"groupDescription":"Statistical analysis between Varenicline and NRT patch.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.7895","pValueComment":"P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"-0.32","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.65","ciUpperLimit":"2.01"},{"groupIds":["OG000","OG003"],"groupDescription":"Statistical analysis between Varenicline and Placebo.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.6804","pValueComment":"P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"-0.48","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.75","ciUpperLimit":"1.80"},{"groupIds":["OG001","OG002"],"groupDescription":"Statistical analysis between Bupropion and NRT patch.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.8127","pValueComment":"P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"0.27","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-1.95","ciUpperLimit":"2.49"},{"groupIds":["OG001","OG003"],"groupDescription":"Statistical analysis between Bupropion and Placebo.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.9218","pValueComment":"P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"0.11","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.04","ciUpperLimit":"2.25"},{"groupIds":["OG002","OG003"],"groupDescription":"Statistical analysis between NRT patch and Placebo.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"0.8841","pValueComment":"P-values are for the risk differences of pairwise comparisons based on the logistic regression model with terms Baseline Cardiovascular Risk, treatment, cohort, region, and treatment by cohort interaction.","statisticalMethod":"Regression, Logistic","paramType":"Risk Difference (RD)","paramValue":"-0.16","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-2.32","ciUpperLimit":"2.00"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"Adverse events were collected from Week 24 visit of study NCT01456936 until the end of study (i.e. Week 52 or date of discontinuation, as applicable).","description":"Safety analysis set: Participants that received at least one dose of study drug during the parent study (i.e., NCT01456936). 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