OSLER‐2.

Study characteristics
Methods	Type of RCT: 1:2 parallel‐group, open‐label stratified trial Settings: outpatient care Duration: 2 years Start and stop dates: April 2014 and June 2018 (including single‐arm extension)
Participants	Number of participants: 3681 Number lost to follow‐up: 169 Women: 1736 (47%) Mean age (SD), years: 59 (11) History of CVD: NA FH participants: NA Participants with and without a history of CVD or FH; all were previously enrolled in phase 2 PCSK9 inhibitor trials and completed these trials without serious adverse events
Interventions	Background therapy: SOC Randomised therapy: evolocumab vs SOC Evolocumab dose: 420 mg every 4 weeks or 140 mg every 2 weeks
Outcomes	CVD, adverse events, all‐cause mortality
Notes	Funded by Amgen
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomisation was performed centrally using an interactive voice‐response or web‐response system.
Allocation concealment (selection bias)	Low risk	Central allocation.
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding.
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Unclear.
Selective reporting (reporting bias)	Low risk	Traditional endpoints.
Other bias	Low risk	No concerns outside the assessed risk of bias domains.