The study protocol was amended once prior to first participant first visit. • This amendment incorporated continued efforts to measure endpoints for all participants until Day 180, even for those who prematurely discontinued study treatment, to avoid missing data. • Included a “Treatment-policy Estimand” that assessed the efficacy of inclisiran in LDL-C lowering irrespective of the addition of other LLTs, in parallel to the original estimand, referred to as “Monotherapy Estimand”. • Included additional guidance for the Investigator on lifestyle instructions to be given to the participants as recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease (Arnett et al 2019). • Updated discontinuation from study treatment criteria to provide additional guidance to the Investigator on specific reasons for discontinuation of study treatment, including liver enzyme elevation and CK criteria, severe and persistent (> 14 days despite appropriatetreatment) reactions at the injection site and any anaphylactic reactions, and intolerable adverse events. • To avoid unnecessary study treatment discontinuations, the action taken in response to addition of other LLTs had been updated so that study treatment was not automatically discontinued when other LLTs were taken after randomization (except for those targeting PCSK9, and RNAi-based therapies).