2.1. Ethics
HEART
The present study was designed as a 12-week, randomized, multicenter, double-blind, placebo-controlled clinical trial with two parallel groups receiving either MED-01 or placebo capsules. The study was performed from January 2021 to April 2022 at Chung-Ang University Hospital, Hallym University Kangnam Sacred Heart Hospital, and Soonchunhyang University Hospital in Seoul, Korea. Prior to the implementation of the trial, the study protocol and consent form were reviewed and approved by the independent clinical trial review board (IRB) of each institution (IRB No. 2091-003-436, HKS 2020-09-005-001, and SCHUH 2021-04-017-002). The information about a clinical trial was registered at the Clinical Research Information Service, the Republic of Korea (accessed on 6 January 2023, 