The Belgian REAL (BE.REAL) Registry

This is an observational non-interventional study. The visit schedule is according to the
routine clinical practice. Only data corresponding to study variables within the
specified study period will be collected.

The study will recruit patients into one single cohort: Inclisiran in combination with
other LLTs. The patients will receive Inclisiran therapy as per the approved label and
Belgian reimbursement conditions. The study aims to assess the effectiveness, safety and adherence for Inclisiran in
combination with lipid-lowering therapy (LLT) under conditions of routine clinical
practice. The Inclisiran cohort will include patients receiving Inclisiran therapy as per
the approved label independently of background Standard of Care (SoC) therapy. This study
will include both primary data collection and secondary use of data.

- Prospective data collection: Patients will be enrolled over a period of 6 months
between 01-December-2022 and 31-May-2023 and will have a maximum follow-up of 39
months or 8 injection visits.

- Retrospective data collection: Retrospective data will also be captured for patients
with a first prescription between 01-May-2022 and study start and will be followed
up for a maximum of 39 months to assess for study outcomes. In this case, baseline
data and data of the first injection visits will be retrieved by the physician and
captured in the Clinical Report Form (CRF), followed by prospective data collection
during the rest of the follow-up period.