Study Design and Treatment
ORION-5 (URL: The study had 2 sequential parts. Part 1 consisted of a 6-month double-blind placebo-controlled phase in which eligible patients were randomized 2:1 to receive either 300 mg of inclisiran sodium (equivalent to 284 mg of inclisiran) subcutaneously or placebo at day 1 and day 90. Part 2 consisted of an 18-month open-label, single-arm phase in which patients already receiving inclisiran continued treatment, and placebo-treated patients from part 1 were transitioned to inclisiran and received their first dose of inclisiran subcutaneously on day 180. All patients in part 2 received subsequent doses of inclisiran on days 270, 450, and 630, with an end-of-study visit on day 720. The study design of ORION-5 is presented in 