Rose 2009.

Study characteristics
Methods	Study design: factorial RCT Country: USA Recruitment: community volunteers
Participants	379 participants, smoking > 15 cigarettes per day for ≥ 3 years, motivated to quit 43% men, average age 42, average cigarettes per day 23, average FTND 6
Interventions	1) Usual brand of cigarette plus 21 mg/24‐hour patch for 2 weeks pre‐quit 2) Usual brand of cigarette plus placebo patch for 2 weeks pre‐quit 3) Low tar and nicotine cigarette plus 21 mg/24‐hour patch for 2 weeks pre‐quit 4) Low tar and nicotine cigarette plus placebo patch for 2 weeks pre‐quit All groups received same treatment post‐quit: 6 weeks 21 mg/24‐hour patch, following 2 weeks 14 mg/24‐hour patch, remaining 2 weeks 7 mg/24‐hour patch
Outcomes	Continuous abstinence at 6 months Validation: CO ≤ 8 ppm Adverse events: not measured
Notes	Treatment had greater effect for those with low FTND Funding provided through grant to Duke University by Philip Morris, USA Conflicts of interest: Dr. Rose has received royalties from sales of certain nicotine patches and is named as inventor on nicotine skin patch patents that expired in 2008.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "a total of 400 subjects were randomly assigned to one of four treatment groups"
Allocation concealment (selection bias)	Unclear risk	Not specified
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote: "two members of the study team…placed the required number of active or placebo patches into individual plastic bags labelled with subject number and session number… In order to maintain blinding, these members of the study team did not interact with study participants."
Incomplete outcome data (attrition bias) All outcomes	High risk	High number lost to follow‐up (169/379)