2.1. Trial design
hypercholesterolemia
HYPERCHOLESTEROLEMIA
This randomized, double-blind, placebo-controlled trial comparing the effects of A5E combination therapy to E, A5, and A10 monotherapy on lipid levels and their safety profiles in patients with hypercholesterolemia was conducted at 19 centers in Korea (ClinicalTrials.gov identifier: NCT05131997). The institutional review board at each site approved the study protocol, and all subjects provided written informed consent.Patients who met the inclusion/exclusion criteria at Visit 1 received a placebo to check for drug compliance and discontinued lipid medications for at least 4 weeks (4 weeks for statins and omega-3 supplements and 6 weeks for fibrates) (Supplementary Table 1, 