Following changes were made: i) updated the statistical section. Based on study design, inferential approach and/or plans regarding generalisability of the results obtained, all pairwise comparisons did not need to reach statistical significance for a study success. The statistical analysis remained unchanged, only the strategy/interpretation of the results was updated. ii) updated study description to clarify the definition of HR and VHR cardiovascular risk subjects. If Systematic Coronary Risk Evaluation (SCORE) was used as assessment criteria for HR or VHR, the value measured before the starting of LMT was to be taken into consideration. In addition, the definition of screening failure was added. iii) added exclusion criteria to prohibit red yeast rice (RYR) products for at least 6 weeks prior to the Screening Visit and/or plan to take these products before the EOT Visit; it was reported that there was up to a 20% reduction in LDL-C with RYR products at a daily dose of ~2.5-10 mg monacolin (2016 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) Guidelines for the Management of Dyslipidemias). iv) added eGFR <30 mL/min/1.73m^2 and eGFR >=30 and <=59 mL/min/1.73m^2 for VHR subjects as reasons for permanent treatment discontinuation taking into consideration the IMP contraindications and the subjects’ profile. v) added definition of AEs of special interest (AESI). Pregnancy occurring in a female partner of a male subject included in the study was added as an AESI. vi) the IMP was to be discontinued only in case of pregnancy occurred in female subject included in the study. vii) changes related to the retaining of the records and the study documents by the Investigators for 25 years after the signature of the final study report. viii) clarified fasting conditions by adding the information that the subjects should not drink anything other than water for 10-12 hours before the blood samples collection.

Following changes were made: i) amended inclusion criterion to reflect the decrease in the LDL-C lower thresholds at screening for the HR and VHR subjects to allow the recruitment of subjects with better controlled hypercholesterolemia already treated with rosuvastatin that might benefit from the treatment with escalated doses of rosuvastatin or FDC. ii) added an exploratory endpoint in reference to the attaining of the new LDL-C targets, as recommended by the ESC and the EAS 2019 Guidelines for the Management of Dyslipidemias (i.e., an LDL-C reduction of >=50% from baseline and an LDL-C goal of <1.8 mmol/L (<70 mg/dL) for HR subjects and an LDL-C reduction of >=50% from baseline and an LDL-C goal of <1.4 mmol/L (<55 mg/dL) for VHR subjects). iii) aligned the general guidance for the follow-up of laboratory abnormalities and IMP discontinuation in case of alanine aminotransferase or creatine kinase increase with Section 7 “Summary of data and guidance for the Investigator” of the Investigator’s Brochure. iv) updated timing of IMP administration to clarify that in the particular situation when the subjects were treated before V2 with statins in the evening, the first run-in rosuvastatin tablet could be taken in the evening. Similarly, in the particular situation when the subjects had taken the run-in rosuvastatin in the evening, the double-blind IMP could be taken in the evening. The Investigator was to instruct the subjects regarding the IMP administration and to report any AE that they might experience.