Schnoll 2010b.

Study characteristics
Methods	Study design: parallel RCT Country: USA Recruitment: community volunteers and physician referrals
Participants	642 treatment‐seeking smokers smoking ≥ 10 cigarettes per day 43% men, average age 45, average cigarettes per day 20.3, average FTND 5.1; average years smoking 26.7
Interventions	Direct comparison of patch versus lozenge 1) Patch: 21 mg/day for first 6 weeks, 14 mg/day for weeks 7 and 8, 7 mg/day for weeks 9 to 12 2) Lozenge: 4 mg for participants who smoked first cigarette of day within 30 minutes of waking; 2 mg for all other participants. Asked to use 9/day for first 6 weeks, 5/day for weeks 7 to 9, 3/day for weeks 10 to 12
Outcomes	24‐hour PPA at 6 months Validation: CO ≤ 10 ppm   Adverse events: measured at end of treatment (12 weeks) and at 6‐month follow‐up
Notes	This study was supported by grant RSGPB‐05‐240‐01‐CPPB to Dr. Schnoll from the American Cancer Society and National Institutes of Health grant U10 101178 to Dr. Paul Engstrom. This work was also supported in part by grants: P50 CA143187, R01 CA126969, R01 DA025078, and R21 DA026889. Conflicts of interest: "Dr. Ferris has received grant funding through his institution to conduct research trials for GSK and Novartis during the past 3 years".
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Randomization was coordinated by Fox Chase Cancer Center and was stratified at each site."
Allocation concealment (selection bias)	Unclear risk	Not specified
Blinding (performance bias and detection bias) All outcomes	High risk	Open‐label trial and although both treatments were active, 2/3 participants had preference for patch
Incomplete outcome data (attrition bias) All outcomes	Low risk	46% loss to follow‐up by 6 months, similar between groups. Missing data reported as smokers