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Article History

Received: 9 August 2022

Accepted: 7 February 2023

First Online: 14 February 2023

Declarations

:

: Institutional review board or independent ethics committee approval was obtained at each participating site (as follows) and the study was conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent has been obtained from the participants involved. This trial was registered at the Clinical Research Information Service of Korea, a member of the WHO International Clinical Trials Registry Platform (ICTRP) with the identification number of KCT0004847.

: Seoul National University Hospital (1905-175-1036), Seoul National University Bundang Hospital (E-1909-564-406), Seoul Metropolitan Government Seoul National University Boramae Medical Center (20-2019-61), Dankook University Hospital (2019-09-001), Chung-Ang University Hospital (1982-004-384), Hallym University Kangnam Sacred Heart Hospital (2019-08-009), National Cancer Center (NCC2019-0298), Myongji Hospital (2019-09-010), Hanyang University Hospital (2019-09-011), Catholic University of Korea Seoul St. Mary's Hospital, College of Medicine (KC19TDDI0796), Korea University Anam Hospital (2020AN0088), Korea University Guro Hospital (2020GR0119) and Gyeongsang National University Hospital (2020-01-030).

: All informed consent was obtained. This manuscript does not contain any individual person’s information.

: This study was supported by the Bertis Inc. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. HM and HS reported being Outside Director; receiving consulting fees as a member of Bertis Inc.;holding stock options of the Bertis Inc. YK reported receiving consulting fees from Bertis Inc. during the conduct of the study; holding stock options of the Bertis Inc. HS reported his family members hold stocks of the Bertis Inc. DN reported being a member of Bertis Inc.;holding equity in Bertis Inc. EL reported receiving honoraria for consultation or advisory board participation from Bertis Inc. No other disclosures were reported.