Conditions: Smoking Cessation
Keywords: smoking cessation psychiatric disease cardiovascular events
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 4595
Healthy volunteers: yes

Brief summary:
Non-treatment extension to study A3051123, aimed at collecting data on cardiovascular safety for all participants in the A3051123 trial for an additional 28 weeks, allowing for a total of 52 weeks of cardiovascular safety data collection.

Detailed description:
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. 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.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: placebo intervention 2: varenicline tartrate intervention 3: bupropion hydrochloride intervention 4: Nicotine Replacement Therapy Patch
Intervention descriptions: intervention 1: All dosing to have taken place per study A3051123 intervention 2: All dosing to have taken place per study A3051123 intervention 3: All dosing to have taken place per study A3051123 intervention 4: All dosing to have taken place per study A3051123

Protocol document: