Berlin 2014.

Methods	Country: France Recruitment: multicentre, advertisements and letters from participating healthcare settings
Participants	403 pregnant smokers (≥ 5 cpd) at 9 to 20 weeks amenorrhoea, motivated to quit 100% female, average age 29, average cpd 11, median FTND 4.5, median gestational age 17 weeks
Interventions	1. Nicotine patch, 16 h, from TQD to delivery. Daily dose 10 to 30 mg/day based on salivary cotinine, adjusted at 6 and 12 weeks post‐randomization 2. Placebo on same schedule Level of support: high (1 h behavioural counselling at baseline, at least 10 mins counselling at following 6 visits)
Outcomes	Continuous abstinence at 20 weeks post‐TQD Validation: CO ≤ 8 ppm
Notes	New for 2017 update 2‐month cessation data post‐delivery also collected but not reported. Data at 20 weeks post‐TQD included in Analysis 5.1.1. Not included in main analysis because follow‐up was less than 6 months Funding: Ministry of Health, France and Assistance publique‐Hôpitaux de Paris
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “A computer generated randomisation list (allocation ratio 1:1) in blocks of four was prepared and kept double blinded.”
Allocation concealment (selection bias)	Low risk	Quote: “…the randomisation number was attributed automatically at the completion of the randomisation visit. A statistician…who was fully independent of the trial, prepared the random, computer generated allocation sequence. The randomisation code was kept in a sealed envelope in a safe. A copy of the randomisation code was kept separately in case of a serious adverse event necessitating exposure of a participant’s group assignment. Investigators, members of the coordination centre, hospital pharmacists, and the study statistician were kept blinded until the code was opened before witnesses on 19 February 2013.”
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote: “All study staff (investigators, pharmacists, members of the coordination centre and of the drug safety monitoring board, laboratory staff, statistician) were double blinded to treatment allocation.” “The placebo patches were manufactured by the same company, with specific quality control guidelines to ensure double blinding.” “Determinations of saliva cotinine levels were carried out blinded. The investigators were not aware of the results” “Data were analysed blinded to treatment”
Incomplete outcome data (attrition bias) All outcomes	High risk	92/203 and 113/199 withdrew, 107/203 and 123/199 not followed up at every visit (needed for strictest measure) (> 50% attrition overall)