ODYSSEY CHOICE I.

Study characteristics
Methods	Type of RCT: 1:2 parallel‐group, double‐blind, stratified RCT Settings: outpatient care Duration: 24 weeks Start and stop dates: October 2013 and May 2015
Participants	Number of participants: 803 Number lost to follow‐up: NA Women: 341 (42%) Mean age (SD), years: 60 (10) History of CVD: NA Participants with FH: 45 (6%) Participants with poorly controlled hypercholesterolaemia and moderate CV risk with or without muscle‐related statin intolerance, or with high CV risk receiving maximally tolerated dose. No definition of poorly controlled or moderate/high CV risk was provided.
Interventions	Background therapy: statin therapy Randomised therapy: alirocumab vs placebo. At 12 weeks, participants could switch to 150 mg every 2 weeks Alirocumab dose: 48 weeks 75 mg every 2 weeks or 300 mg every 4 weeks. Resulting in a 2‐week equivalent dose of 75–150 mg. Treatment was allocated stratified on statin use or not
Outcomes	Adverse events, all‐cause mortality
Notes	All results based on an abstract Results presented as alirocumab vs placebo NCT01926782 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)	Unclear risk	Not reported.
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Placebo controlled trial.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Clinical events committee and blinded assessment using a central laboratory.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No details of missing data provided.
Selective reporting (reporting bias)	Low risk	Reported protocol‐defined endpoints.
Other bias	Low risk	No concerns outside the assessed risk of bias domains.