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Article History

Received: 11 October 2025

Accepted: 20 January 2026

First Online: 24 February 2026

Declarations

:

: This study was approved by the Institutional Ethics Review Board of Seoul National University Hospital (No. H-2211–115-1380) (Latest version 2.3). The ethics approval for this study has been obtained from all participating institutions. In Australia, approval was granted by Epworth Hospital (EH2022-940; IRB approval date: Jan 08, 2024; latest version 1.5). In Taiwan, approvals were obtained from the following institutions: National Taiwan University Hospital (IRB approval date: Aug 14, 2025; version 3.8), Linkou Chang Gung Memorial Hospital and Kaohsiung Chang Gung Memorial Hospital (IRB approval date: May 15, 2025; version 3.6), Taipei Veterans General Hospital (IRB approval date: May 21, 2025; version 3.6), Taichung Veterans General Hospital (IRB approval date: Aug 13, 2025; version 2.0), China Medical University Hospital (IRB approval date: Apr 02, 2025; version 3.1), Kaohsiung Medical University Chung-Ho Memorial Hospital (IRB approval date: Jan 21, 2025; version 2.0), Tri-Service General Hospital (IRB approval date: Aug 08, 2025; version 3.7), and National Cheng Kung University Hospital (coordinating center in Taiwan) (IRB approval date: Feb 25, 2025; version 3.6; B-BR-113–070). This study was conducted in compliance with the Declaration of Helsinki as amended in 2013.The patients treating physicians, local investigator, or research nurse of the participating centers follow Good Clinical Practice (GCP) and other applicable regulations in informing the patient and obtaining consent. Before informed consent may be obtained, the investigator should provide the patient ample time and opportunity to inquire about details of the trial and to decide whether or not to participate in the trial. All questions about the trial should be answered to the satisfaction of the patient. Patients are well informed that participation in voluntary and that they may withdraw at any point during the study. Informed consent includes consent for collection and use of biological specimens (i.e. blood and tissue). Written informed consent of patients is required before enrollment in the trial or study related procedures take place. All data are handled with strict confidentiality, assuring anonymity of patients.Any proposed amendments to the project including any changes will be submitted to the Ministry of Food and Drug Safety (KFDA) for approval prior to implementation. These changes will be provided to the trial participants immediately by the main research team and re-consent for participation in the research will be collected if required.

: Not applicable.

: The authors declare no competing interests.