Trial design
This study was an open-label, randomized, controlled clinical trial conducted at two large tertiary academic medical centers (Severance Hospital and Seoul National University Hospital) in Korea between January 2019 and October 2021. This study was approved by the Institutional Review Board (IRB) of Yonsei University Health System (IRB No. 4–2018-0359) and Seoul National University Hospital (IRB No. H-1712–158-912). The protocol was registered on ClinicalTrials.gov (Identifier: NCT04033276, first trial registration 26/07/2019) and conducted in accordance with the principles of the Declaration of Istanbul and the Declaration of Helsinki. All patients provided informed consent. The requirement for informed consent of patients who were retrospectively recruited from Severance Hospital was waived by IRB of Yonsei University Health System (IRB No. 4–2022-1125) because of the retrospective nature of the study.