RIO‐Lipids.

Methods	DURATION OF INTERVENTION: 12 months DURATION OF FOLLOW‐UP: 0 months RUN‐IN PERIOD: 1 LANGUAGE OF PUBLICATION: English
Participants	WHO PARTCIPATED: INCLUSION CRITERIA: Age: 18 to 70 years old; BMI of 27 to 40 kg/m2; TG of 1,7 to 7,9 mmol/L chol/HDL >5 (men) and >4,5 (women) variation in body weight within the previous three months < 5kg EXCLUSION CRITERIA: history of pharmacologic treatment for dyslipidemia 6 weeks before or treatment with VLCD 6 months before; type 1 or 2 diabetes; clinically significant findings indicating cardiovascular disease, endocrine, pulmonary, neurologic, psychiatric, gastrointestinal, hepatic, hematologic, renal or dermatologic disease; + test for hepatitis B surface antigen or hepatitis C antibody, abnormal thyrotropin level; levels of alanine aminotransferase or aspartate aminotransferase > 2,5 times the upper limit; haemoglobin levels < 11g/dl; neutrophil levels < 1500 ml3; platelet levels < 100,000 ml3; creatinine levels > 150mmol/L; a history of marijuana or hashish use; severe depression; treatment for epilepsy, an eating disorder; malignant disease; BP > than 165 or 105 mm Hg; pregnancy; or lactation; < 80% compliance with a hypocaloric diet and placebo during the post‐screening four week single blind run in period. DIAGNOSTIC CRITERIA: ?
Interventions	NUMBER OF STUDY CENTRES: 67 COUNTRY/LOCATION: 8 countries ‐ ? SETTING: ? INTERVENTION (ROUTE, TOTAL DOSE/DAY, FREQUENCY): Placebo or rimonabant 20 mg or rimonabant 5 mg ‐ daily in addition to a hypocaloric diet
Outcomes	PRIMARY: weight change SECONDARY: changes in HDL, TG, Glucose and insulin during an oral glucose‐tolerance test and the prevalence of metabolic syndrom ADDITIONAL: waist circumference, leptin and adiponectin levels and relevant biochemical cardiovascular markers TIMING OF OUTCOME MEASURES: body weigh, BP, waist circumference ‐ monthly, the other measures only 12 months 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