ODYSSEY HIGH FH

Methods	Type of RCT: 2:1 parallel‐group, double‐blind, stratified RCT Settings: outpatient care Duration: 78 weeks Start and stop dates: 12/2012 and 01/2015
Participants	Number of participants: 107 Number lost to follow‐up: 1 Women: NA Age (SD), years: NA History of CVD: 64 (60%) Participants with FH: 107 (100%) Participants with heterozygous familial hypercholesterolaemia on a maximally tolerated dose of statin with LDL‐C ≥ 160 mg/dL
Interventions	Background therapy: both add‐on to maximal tolerated dose of statin and possible addition of other lipid‐lowering therapies Randomized therapy: alirocumab vs placebo Alirocumab dose: 78 weeks of 150 mg alirocumab every 2 weeks
Outcomes	CVD, lipids, any adverse events, all‐cause mortality
Notes	LDL‐C was calculated using the Friedewald formula Reports on influenza Subgroup analyses are provided for FH I and FH II combined NCT01617655
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Centralised interactive voice‐response system or interactive Web‐response system
Allocation concealment (selection bias)	Low risk	Central allocation
Blinding of participants and personnel (performance bias) LDL‐C	Low risk	Both were blinded
Blinding of outcome assessment (detection bias) LDL‐C	Low risk	Central laboratory
Incomplete outcome data (attrition bias) All outcomes	Low risk	1 (1.38%) participant in the alirocumab arm had missing lipid measurements compared with 0 in the comparator arm. Additionally, mixed‐effects (ANCOVA) models were used
Selective reporting (reporting bias)	Unclear risk	Full paper has not yet been published
Other bias	High risk	Funded by Sanofi and Regeneron