{"description":"Administered a checklist of side effects from NRT and collected any additional information on adverse events.","eventGroups":[{"description":"Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.","id":"EG000","otherNumAffected":0,"otherNumAtRisk":321,"seriousNumAffected":4,"seriousNumAtRisk":321,"title":"Arm I"},{"description":"Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).","id":"EG001","otherNumAffected":0,"otherNumAtRisk":321,"seriousNumAffected":7,"seriousNumAtRisk":321,"title":"Arm II"}],"frequencyThreshold":"1","seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":321,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":321,"numEvents":0}],"term":"Stroke"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":321,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":321,"numEvents":1}],"term":"Seizure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":321,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":321,"numEvents":0}],"term":"killed in car accident"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":321,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":321,"numEvents":1}],"term":"Heart disease"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":321,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":321,"numEvents":1}],"term":"ulcer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":321,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":321,"numEvents":1}],"term":"appendicitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":321,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":321,"numEvents":1}],"term":"heart attack"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":321,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":321,"numEvents":1}],"term":"cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Surgical and medical procedures","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":321,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":321,"numEvents":1}],"term":"Abcessed tooth"}],"timeFrame":"6 months"}