5.1. Study Design
This study was designed as a randomized, double-blind, active-drug-controlled, multicenter, phase 3 trial conducted in six university hospitals (Asan Medical Center, Gangnam Severance Hospital, Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, Kyung Hee University Hospital at Gangdong, Sinchon Severance Hospital) in Seoul, Korea between September 2021 and March 2023. This research adhered to the study protocol, followed the Good Clinical Practice guidelines, and complied with all relevant regulatory prerequisites. It received approval from the Ministry of Food and Drug Safety and the Institutional Review Boards of the participating institutions. Additionally, written informed consent was obtained from all participants prior to their enrollment. After the subject had voluntarily consented in writing to participate in this clinical trial, the investigator conducted a screening of the subject. After that, only test subjects who met the selection/exclusion criteria were enrolled.