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. 2017 Sep 7;2017(9):CD011823. doi: 10.1002/14651858.CD011823.pub2

Killen 2010.

Methods 8‐Week double‐blind randomized placebo‐controlled clinical trial
Setting: community‐based, USA
Recruitment: community recruitment through radio, newspapers, community website, and notices distributed via local organisations
Study period: May 2006 to July 2008
Participants N = 243
Inclusion criteria: 18 to 65 years of age; smoked 10 or more cigarettes a day
Males: 70%; average age: 45; average cigarettes/d: 19
Interventions Selegiline patch for 8 weeks, 6 mg/24 hours, starting on TQD vs identical placebo patch on same schedule
Both groups received 9 sessions of individual cognitive‐behavioural therapy.
Outcomes Primary outcome: point prevalence abstinence (PPA) at week 25 and week 52 (i.e. report of non‐smoking (not even a puff) for 7 consecutive days before contact and an expired air carbon monoxide level < 10 ppm)
Secondary outcomes: time to relapse; occurrence, duration, and severity of adverse events
Funding source National Institute on Drug Abuse; medication and matching placebo were provided by Somerset Pharmaceuticals, Inc.
Declaration of interest Dr Schatzberg served as a consultant for Somerset Pharmaceuticals.
Notes Analyses of pharmacogenomics are reported in Sarginson 2015 (N = 231 with DNA samples; 77.1% Caucasian, 9.1% Hispanic, 3.9% Asian, 1.3% black, 0.4% other, and 8.2% mixed ancestry).
All analyses of pharmacogenomics were performed in both the full cohort and the Caucasian‐only cohort.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Use of random number generator
Allocation concealment (selection bias) Low risk Participants were assigned sequential ID numbers corresponding to drugs used. Also: “The drug (active or placebo) associated with each ID was pre‐packaged and labelled by ID only at an off‐site location by an individual who had no association with the participants.”
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk “Treatment assignment was concealed from staff and both research staff and participants were blind to week 52.”
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk “Treatment assignment was concealed from staff and both research staff and participants were blind to week 52.”
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Follow‐up at 12 months: 87% (same in both arms)
Selective reporting (reporting bias) Low risk Registered in clinicaltrials.gov under NCT01330030; no deviation from prespecified outcomes
Other bias Low risk 12 people did not provide DNA for analyses of pharmacogenomics; use of PCA was included in analyses of pharmacogenomics.