ODYSSEY MONO

Methods	Type of RCT: 1:1 1:1 parallel‐group, double‐blind RCT Settings: outpatient care Duration: 24 weeks Start and stop dates: 07/2012 and 07/2013
Participants	Number of participants: 103 Number lost to follow‐up: 0 Women: 48 (47%) Age (SD), years: 60 (5) History of CVD: 103 (100%) Participants with FH: 0 Participants with 10‐year risk of fatal CV events between 1% and < 5%
Interventions	Background therapy: National Cholesterol Education Program Adult Treatment Panel III therapeutic lifestyle changes diet Randomized therapy: alirocumab and placebo ezetimibe daily vs 10 mg ezetimibe daily plus alirocumab biweekly placebo Alirocumab dose: 24 weeks 75 mg alirocumab every 2 weeks, at 12 weeks LDL‐C dependent uptitration of alirocumab occurred to 150 mg biweekly. Resulting in a 2‐week equivalent dose of 75 mg to 150 mg
Outcomes	CVD, lipids, any adverse events
Notes	· LDL‐C was calculated using the Friedewald formula · NCT01644474
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not reported
Allocation concealment (selection bias)	Low risk	Permuted‐block design
Blinding of participants and personnel (performance bias) LDL‐C	Low risk	Participants were blinded for treatment allocation and self‐administered treatments
Blinding of outcome assessment (detection bias) LDL‐C	Low risk	Central laboratory
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants were available at 24 weeks of follow‐up
Selective reporting (reporting bias)	Low risk	Reports on protocol‐defined endpoints
Other bias	High risk	Funded by Sanofi and Regeneron