2. Methods
RECRUITMENT
The Institutional Review Board of the Seoul National University College of Medicine approved this study (number: H-2107-220-1240, date: August 24, 2021). The study was registered at ClinicalTrials.gov before patient recruitment (NCT05043844, September 13, 2021, principal investigator: Hee-Soo Kim). Only patients who provided written informed consent were enrolled to participate in this study. We conducted this study in compliance with the Good Clinical Practice guidelines and the Helsinki Declaration, and the report was written based on the applicable Consolidated Standards of Reporting Trials guidelines.