RIO‐Europe.

Methods	DURATION OF INTERVENTION: 12 months DURATION OF FOLLOW‐UP: 0 RUN‐IN PERIOD: 1 ‐ 4 weeks LANGUAGE OF PUBLICATION: English
Participants	WHO PARTCIPATED: INCLUSION CRITERIA: BMI > 30 or 27 with hypertension or dyslipidaemia patients had less than 5 Kg variation within 3 months before EXCLUSION CRITERIA: clinical disorders (endocrine disease, diabetes, cardiovascular, pulmonary, hepatic, renal, neurological, psychological, severe depression); previous history of surgical procedures for weight loss; concomitant use of medications known to alter body weight or appetite was not allowed; marijuana or hashish use. DIAGNOSTIC CRITERIA:
Interventions	NUMBER OF STUDY CENTRES: 60 (40 ‐ Europe and 20 ‐ USA) COUNTRY/LOCATION: Europe and USA 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 SECONDARY: waist circumference, glucose and insuline in serum when fasting, HDL and TG and the prevalence of metabolic syndrome ADDICIONAL changes in total cholesterol and LDL, changes in insulin resistance TIMING OF OUTCOME MEASURES: body weight, waist circumference, BP ‐ monthly fasting glucose and insulin ‐ every 3 months other measures ‐ 12 months ALL‐CAUSE MORTALITY. 0 DISEASE SPECIFIC MORTALITY: 0 MORBIDITY/COMPLICATIONS: 1 QUALITY OF LIFE: 1, but not analysed ADVERSE EFFECTS: 1 COSTS: 0
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate