{"groups":[{"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":"FG000","title":"Nicotine Patch"},{"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":"FG001","title":"Nicotine Lozenge"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"139"},{"groupId":"FG001","numSubjects":"154"}],"type":"Lost to Follow-up"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"321"},{"groupId":"FG001","numSubjects":"321"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"182"},{"groupId":"FG001","numSubjects":"167"}],"type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"139"},{"groupId":"FG001","numSubjects":"154"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"1299 individuals were screened for this trial over 4 years; 454 individuals were ineligible, 194 refused enrollment, and 651 were randomized. Nine individuals either withdrew from the study prior to treatment or were found to be ineligible after randomization and were removed from the intent-to-treat sample. The final ITT sample was 642 (321/arm).","recruitmentDetails":"Participants were recruited through ads/physician referral at: FCCC, Geisinger Medical Center, Hematology Oncology Associates of Central NY, Howard University, LSU, Main Line Health System, Medical College of GA, Meharry Medical College, Mount Sinai Medical Center (Miami), North Shore University, SUNY Downstate Medical Center, and Virtua Health."}