{"eventGroups":[{"description":"Patients receive oral varenicline once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.\n\nvarenicline: Given orally","id":"EG000","otherNumAffected":0,"otherNumAtRisk":137,"seriousNumAffected":4,"seriousNumAtRisk":137,"title":"Arm I"},{"description":"Patients receive oral varenicline placebo once daily on days 1-3 and twice daily thereafter for a total of 6 months or when a comfortable level of smoking abstinence is reached.\n\nplacebo: Given orally","id":"EG001","otherNumAffected":0,"otherNumAtRisk":45,"seriousNumAffected":2,"seriousNumAtRisk":45,"title":"Arm II"},{"description":"Patients receive a nicotine patch, with doses tapering over time for a total of 26 weeks. Patients also receive nicotine gum to quell breakthrough urges. Patients may stop treatment when a comfortable level of smoking abstinence is reached.\n\nnicotine: Given transdermally and orally","id":"EG002","otherNumAffected":0,"otherNumAtRisk":133,"seriousNumAffected":2,"seriousNumAtRisk":133,"title":"Arm III"}],"frequencyThreshold":"0","seriousEvents":[{"notes":"Participant described hearing voices","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":133,"numEvents":0}],"term":"Neurobehavioral Adverse Effects"},{"notes":"Participant reported mood disturbance","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":137,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":133,"numEvents":0}],"term":"Neurobehavioral Adverse Events"},{"notes":"Participant died during study participation","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":137,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":45,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":133,"numEvents":1}],"term":"Participant Death"},{"notes":"Participant was hospitalized with symptoms of heat attack","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":137,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":133,"numEvents":1}],"term":"Heart Attack"},{"notes":"Participants complained of skin rashes","organSystem":"Skin and subcutaneous tissue disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":137,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":45,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":133,"numEvents":0}],"term":"Skin Rash"}]}