Bohadana 2000.

Study characteristics
Methods	Study design: parallel RCT Country: France Recruitment: community volunteers
Participants	400 smokers, 18 to 70 years, > 10 cigarettes per day, > 1 previous quit attempt, motivated 49% men, average cigarettes per day: Group 1: 26.1, Group 2: 23.5; FTND > 6 Participants required to be motivated to quit
Interventions	1) Nicotine inhaler, 26 weeks, combined with nicotine patch (15 mg/16‐hour) for first 6 weeks, placebo patch for next 6 weeks 2) Nicotine inhaler, 26 weeks, placebo patch for first 12 weeks
Outcomes	Sustained abstinence at 12 months (prolonged from week 2, no slips allowed) Validation: CO < 10 ppm at each visit (2 weeks, 6 weeks, 6 months, 12 months) (Study also reports respiratory symptoms and pulmonary function tests for completely abstinent participants) Adverse events: measured to 1‐year follow‐up (treatment ceased at 6 months)
Notes	Gender subgroup results reported 2003 This study was supported by a grant from Pharmacia and Upjohn Consumer Healthcare. Conflicts of interest: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "computer‐generated randomization code"
Allocation concealment (selection bias)	Low risk	Quote: "sealed randomization envelopes were provided for each subject and were held by the hospital pharmacy, which was responsible for dispensing medication"
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Described as double‐blind
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Losses over 12 months were steep but similar in both groups, i.e. 148 from NRT group and 155 from placebo group. Losses counted as continuing smokers