ODYSSEY CHOICE II

Methods	Type of RCT: 1:2 parallel group, double‐blind RCT. Settings: outpatient care. Duration: 24 weeks Start and stop dates: 12/2013; 06/2017
Participants	Number of participants: 233 Number lost to follow‐up: NA Women: 103 (44%) Age(SD): 63 (10) History of CVD: NA FH participants: 29 (12%) Participants with primary hypercholesterolaemia (heFH or non‐FH) with high CV risk with muscle related statin intolerance, or moderate CV risk without muscle related statin intolerance.
Interventions	Background therapy: ezetimibe, fenofibrate or diet alone. Randomized therapy: alirocumab versus placebo. Alirocumab dose: 24 weeks of 75 mg alirocumab every 2 weeks or 150 mg Alirocumab every 4 weeks. At 12 weeks participants could switch to 150 mg every 2 weeks. Resulting in a two week equivalent dose of 75‐150mg.
Outcomes	lipids, any adverse events, all‐cause mortality.
Notes	All results based on an abstract. Results presented as Alirocumab versus placebo. NCT0203879
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 however no details are provided on who was blinded. However, taking account of the other Odyssey trials seems likely both patients 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 trails implemented blinded assessment.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	No details are provided on missing data.
Selective reporting (reporting bias)	Unclear risk	The full paper has not yet been published.
Other bias	High risk	Funded by Sanofi and Regeneron.