1 Shanahan 2017.

Study characteristics
Methods	Country: USA Recruitment: Not specified Setting:30 clinical research sites in the USA experienced in smoking cessation trials Study start date: 28 February 2014; Study end date: 15 May 2014
Participants	Total N: 603 smokers, 18 ‐ 65 years, smoking ≥ 10 cpd for the past year with no period of abstinence > 3 months, motivated to quit smoking, BMI 18.5 – 38.0 and at least 50 kg N per arm: Placebo = 200; Lorcaserin 10 mg daily = 202; Lorcaserin 10 mg twice a day = 201 54.4% female, av age 45.6, av baseline BMI 27.8, av baseline weight 80.4 kg, av cpd 18, av FTND 5.6.
Interventions	Placebo for 12 weeks Lorcaserin 10 mg once daily (daily) for 12 weeks Lorcaserin 10 mg twice daily (twice a day) for 12 weeks. All participants received standard smoking cessation counselling by a trained counsellor. Counselling sessions were individual, face‐to‐face and 10 mins long
Outcomes	Mean (SD) weight change (kg) in abstainers at EOT Adverse events by intervention arm at EOT
Study funding	“This study was funded by Arena Pharmaceuticals, Inc. and Eisai, Inc.”
Author declarations	“JER is a consultant to Arena Pharmaceuticals. All other authors (WRS, AG, SS, and MS‐K) were full‐time employees of Arena Pharmaceuticals, Inc. at the time of trial design and execution, data analysis, and manuscript preparation and are shareholders.”
Notes	This study is new to the 2021 update
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “The contract research organization created the randomization codes using a random number generator.”
Allocation concealment (selection bias)	Low risk	Quote: “Qualifying participants were centrally randomized in a 1:1:1 ratio to the three treatment options.”
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: “The contract research organization maintained the database and the treatment blind until after database lock. All site, contract, and sponsor personnel involved with conduct or analysis of the trial remained blinded until after database lock.”
Blinding of outcome assessment (detection bias) Smoking	Low risk	Quote: “…weekly exhaled carbon monoxide measurements (MicroCO™/Carefusion)…” "The prespecified primary endpoint was the continuous abstinence rate for the last 4 weeks of the trial, weeks 9–12 (month 3) in the modified Intent‐to‐Treat (mITT) population. Secondary endpoints included continuous abstinence for weeks 5–8 (month 2) and for weeks 3–12, the weekly point prevalence of abstinence for weeks 3–12. To meet abstinence endpoints, participants had to specify no nicotine use, not even one puff, during the evaluated period, confirmed by weekly exhaled carbon monoxide values of ≤10 ppm.“
Blinding of outcome assessment (detection bias) Weight	Low risk	Quote: “Weight was measured in the fasting state post voiding in the morning, in patient gown and undergarments using certified scales sensitive to within 100 grams supplied by the sponsor.”
Incomplete outcome data (attrition bias) All outcomes	Low risk	“Week 12 completion rates were 70.0% for placebo, 72.8% for lorcaserin QD, and 85.1% for lorcaserin BID participants”