ODYSSEY CHOICE I

Methods	Type of RCT: 1:2 parallel‐group, double‐blind, stratified RCT Settings: outpatient care. Duration: 24 weeks Start and stop dates: 10/2013 and 05/2015
Participants	Number of participants: 803 Number lost to follow‐up: NA Women: 341 (42%) 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. Randomized therapy: alirocumab vs placebo. At 12 weeks, participants could switch to 150 mg every 2 weeks Alirocumab dose: 48 weeks 75 mg alirocumab every 2 weeks or 300 mg alirocumab every 4 weeks. Resulting in a 2‐week equivalent dose of 75 mg to 150 mg. Treatment was allocated stratified on statin use or not
Outcomes	Lipids, any adverse events, all‐cause mortality
Notes	All results based on an abstract Results presented as alirocumab vs placebo NCT01926782
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) LDL‐C	Unclear risk	Described as double‐blind, but no details provided on who was blinded. However, taking account of the other Odyssey trials, seems likely both participants and personal were blinded
Blinding of outcome assessment (detection bias) LDL‐C	Low risk	No details are provided. However, LDL‐C and other biomarkers are unlikely biased by any lack of blinded assessment. Furthermore, all other Odyssey trials implemented blinded assessment using a central laboratory
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No details of missing data are provided
Selective reporting (reporting bias)	Unclear risk	Full paper has not yet been published
Other bias	High risk	Funded by Sanofi and Regeneron