2 Fiore 1994B.

Study characteristics
Methods	Country: USA Recruitment: community volunteers Study start date: Not specified; Study end date: Not specified
Participants	112 smokers, av age 43 ‐ 45 yrs, av weight 72 ‐ 73 kg
Interventions	Nicotine patch (22 mg/24‐hr, 6 wks incl weaning) Placebo patch All participants received x 8 weekly 10 ‐ 20 min individual counselling
Outcomes	Mean (SD) weight change (kg) in point prevalence abstainers at end of treatment (email communication) (validation: CO < 10 ppm)
Study funding	"This study was supported by a research grant provided by Elan Pharmaceutical Research Corporation, Gainesville, Ga, and Athlone, Ireland"
Author declarations	Not specified
Notes	PPA was defined as validated self‐report abstinence for 7 days prior to measurement Different participants to 2 Fiore 1994A added in separately in the main comparison
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Pregenerated computer sequence
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Double‐blind, placebo‐controlled. No further information given
Blinding of outcome assessment (detection bias) Smoking	Low risk	Quote “a CO level >= 10 ppm indicated smoking”
Blinding of outcome assessment (detection bias) Weight	Unclear risk	Unclear how weight was measured and also unclear if participants were blinded to treatment allocation
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Quote: “Of the 112 subjects who were enrolled and randomized, 79 completed the active treatment phase of the study. Of the 33 who failed to complete the treatment phase (first 6 weeks on study), 18 had placebo patches and 15 active treatment. 72 were interviewed at the 6‐month follow‐up mark.”