Winst 2006.

Methods	Double‐blind parallel‐group placebo‐controlled randomised clinical trial Study period: June 2006 to February 2008
Participants	N = 420 Participants included hospitalised smokers who needed to stop smoking at admission. Participants were approached by information presented in the general hospital admission leaflet and/or on the intranet and by active recruitment by smoking consults in specific departments of the hospital. Inclusion criteria: over 18 years of age; daily consumption of ≥ 15 cigarettes in the past 3 years and average daily consumption of 10 cigarettes the week before study inclusion; life expectancy of ≥ 1 year; conscious and approachable; able to read and sign an informed consent form; Dutch‐ or French‐speaking; expected duration of hospitalisation ≥ 72 hours; treating physician and anaesthetist agree on the patient’s study inclusion Exclusion criteria: already using NS within 14 days before study inclusion; use of tobacco products other than cigarettes; alcohol abuse of > 5 U/d; simultaneous use of psychoactive drugs or hallucinogens; referred from other hospitals; existing contraindications for NS use; predicted postoperative ICU stay longer than 48 hours; pregnant or lactating
Interventions	15 minutes counseling + placebo patch (n = 210) 15 minutes counseling + nicotine transdermal patch (n = 210) Participants received a nicotine transdermal patch at a 15 mg/16 hours dose, daily, for maximum 7 days after hospital admission (study inclusion), or a placebo patch for the same study duration.
Outcomes	Primary outcome: total addiction score, calculated from the Minnesota questionnaires, taken up at randomisation, after ≥ 72 hours of hospital admission and after a maximum of 7 treatment days Additional outcomes: point prevalence of quit rate at short (7 days) and long term (6 months)
Funding source	Study was conducted through a grant from the Foundation of Scientific Research (FWO number G.0604.06), Vlaamse Liga tegen Kanker, and an independent research grant from McNeil AB, Helsingborg, Sweden.
Declaration of interest	Apart from the funding source, study authors report no other relevant affiliations or financial involvement with any organisation or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript, apart from those disclosed.
Notes	All information from this study is extracted from the study protocol; thus information regarding sample size should be interpreted as the initial target rather than the actual number of recruited participants. Analysis of pharmacogenetics is reported in De Ruyck 2010.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was performed via an online‐available registration and randomisation website.
Allocation concealment (selection bias)	Unclear risk	Randomisation occurred online, but it is unclear whether allocation was properly concealed.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Active and placebo medications were identical in appearance, and the study is labeled as double‐blind. No additional details are presented.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Outcome is subjective and can be influenced by study participants.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Final study report not available
Selective reporting (reporting bias)	Unclear risk	Final study report not available
Other bias	Unclear risk	Final study report not available

BUP: bupropion; CBTD: cognitive‐behavioural treatment for depression; CES‐D: Center for Epidemiologic Studies Depression Scale; CO: carbon monoxide; DSM‐IV: Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition; DSM‐IV‐TR, Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition, Text Revision; EOT: end of therapy; FTND: Fagerstrom Test of Nicotine Dependence; GHC: Group Health Cooperative; HE: health education; ITT: intention‐to‐treat analysis; MAO: monoamine oxidase; MAOI: monoamine oxidase inhibitor; MI: myocardial infarction; MINI: Mini‐International Neuropsychiatric Interview; NARSAD: National Alliance for Research on Schizophrenia and Depression; NIAAA: National Institute on Alcohol Abuse and Alcoholism; NIDA: National Institute on Drug Abuse; NIHR: National Institute on Health Research; NRT: nicotine replacement therapy; NST: nicotine sublingual tablet; PCA: Principal Component Analysis; PLAC: placebo; PPA: point prevalence abstinence; ppm: parts per million; SR: sustained‐release; ST: standard treatment; TQD: target quit date; UKCRC: UK Clinical Research Collaboration; UKCTCS: UK Centre for Tobacco Control Studies.