Paoletti 1996.

Study characteristics
Methods	Study design: parallel RCT Country: Italy Recruitment: community volunteers
Participants	297 smokers (≥ 10 cigarettes per day), motivated to quit Stratified according to baseline cotinine levels 60% men, average age 43, average cigarettes per day 24 in low cotinine group (n = 120), 30 in high group (n = 177)
Interventions	Stratum A (baseline cotinine < 250 ng/mL) 1) Nicotine patch (15 mg/16‐hour, 18 weeks including taper) 2) Placebo patch Stratum B (baseline cotinine > 250 ng/mL) 3) Nicotine patch 15 mg 4) Nicotine patch 25 mg
Outcomes	PPA at 12 months Validation: CO and plasma cotinine Adverse events: measured at visits. Note: participants were only asked about particular symptoms (none of which were cardiac)
Notes	This study was supported by a grant from Pharmacia. Conflicts of interest: AC and FM were recipients of a fellowship at the University of Pisa, sponsored by Pharmacia
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation stratified on plasma cotinine levels. No detail on methods used
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Described as double‐blind. All participants got 2 patches, to ensure maintenance of blinding
Incomplete outcome data (attrition bias) All outcomes	Low risk	Losses to follow‐up fully reported