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. 2023 Jun 19;2023(6):CD013308. doi: 10.1002/14651858.CD013308.pub2

Tønnesen 2000.

Study characteristics
Methods Study design: parallel RCT
Country: Denmark
Recruitment: referrals to lung clinic
Participants 446 smokers ≥ 10 cigarettes per day
48% men, average age 49, average cigarettes per day 18
Interventions 1) 5 mg nicotine patch (placebo)
2) 15 mg (16‐hour) nicotine patch for 12 weeks (up to 9 months on request)
3) Nicotine inhaler (4 to 12/day ad lib)
4) Combination, 15 mg patch and inhaler
Outcomes Sustained abstinence at 12 months, (from week 2, paper also reports PPA and with slips rates)
Validation: CO < 10 ppm at all visits
Adverse events: measured at every follow‐up to 12 months (note: treatment could continue to 12 months)
Notes This study was supported by a grant from Pharmacia & Upjohn, Helsingborg, Sweden and the Danish Lung Foundation.
Conflicts of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "a computer‐generated list with random numbers"
Allocation concealment (selection bias) Unclear risk Not stated
Blinding (performance bias and detection bias)
All outcomes Unclear risk Not used ‐ open‐label trial
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Non‐attenders or lost to follow‐up were included as smokers