ODYSSEY MONO.

Study characteristics
Methods	Type of RCT: 1:1 parallel‐group, double‐blind RCT Settings: outpatient care Duration: 24 weeks Start and stop dates: July 2012 and July 2013
Participants	Number of participants: 103 Number lost to follow‐up: 0 Women: 48 (47%) Mean 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 Randomised therapy: alirocumab and placebo ezetimibe daily vs ezetimibe 10 mg daily plus alirocumab biweekly placebo Alirocumab dose: 24 weeks 75 mg every 2 weeks, at 12 weeks LDL‐C‐dependent uptitration occurred to 150 mg biweekly. Resulting in a 2‐week equivalent dose of 75–150 mg
Outcomes	CVD, adverse events
Notes	LDL‐C calculated using Friedewald formula NCT01644474 Funded by Sanofi and Regeneron
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) All outcomes	Low risk	Participants were blinded for treatment allocation and self‐administered treatments.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Endpoint adjudication was blinded and 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	Reported protocol‐defined endpoints.
Other bias	Low risk	No concerns outside the assessed risk of bias domains.