RIO‐North America.

Methods	DURATION OF INTERVENTION: 24 months DURATION OF FOLLOW‐UP: 0 RUN‐IN PERIOD: 1 ‐ 4 weeks LANGUAGE OF PUBLICATION: English
Participants	WHO PARTCIPATED: INCLUSION CRITERIA: 18 years or older; BMI of 30 or 27 with treated or untreated dyslipidemia or hypertension EXCLUSION CRITERIA: weight fluctuation of more than 5 Kg in the previous 3 months; clinically significant cardiac, renal, hepatic, gastrointestinal tract, neuropsychiatric or endocrine disorders, drug‐treated or diagnosed type 1 or 2 diabetes, use of medications that alter body weight or appetite, a history of current substance abuse; changes in smoking habits or smoking cessation within the past 6 months DIAGNOSTIC CRITERIA:
Interventions	NUMBER OF STUDY CENTRES: 72 (64 ‐ USA and 8 ‐ Canada) COUNTRY/LOCATION: USA and Canada SETTING: INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY): Placebo or rimonabant 20 mg or rimonabant 5 mg ‐ once/day in addition to a hypocaloric diet and stimulus for exercising
Outcomes	PRIMARY: weight change in 1 year prevention of weight regain between the first and second years SECONDARY: changes in HDL in 1 year and the prevalence of metabolic syndrom ADDITIONAL: changes in BP, levels of glucose and insulin, lipids, and insulin resistence TIMING OF OUTCOME MEASURES: in the end of year 1 and 2 ALL‐CAUSE MORTALITY. 0 DISEASE SPECIFIC MORTALITY: 0 MORBIDITY/COMPLICATIONS: 1 QUALITY OF LIFE: 0 ADVERSE EFFECTS: 1 COSTS: 0
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

BMI ‐ body mass index; hgA1c ‐ hemoglobinaA1c; HDL ‐ high density lipoprotein; TG ‐ triglycerides; BP ‐ blood pressure; LDL ‐ low density lipoprotein; chol/HDL ‐ ratio total cholesterol / HDL; VLCD ‐ very low calory diet