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Article History

Received: 29 April 2024

Accepted: 20 January 2025

First Online: 3 February 2025

Declarations

:

: The study protocol and informed consent documentation were reviewed and approved by the institutional review boards for all four studies: Seoul National University Hospital Institutional Review Board, Seoul, Republic of Korea (Chinese/Japanese SRD study); Ethik-Kommission der Landesärztekammer Baden-Württemberg, Stuttgart, Germany (European SRD and MRD studies); and SOUSEIKAI Hakata Clinic, Fukuoka, Japan (Japanese MRD study). The studies were conducted in accordance with the principles of the Declaration of Helsinki, the International Conference on Harmonization–Good Clinical Practice, and applicable regulatory requirements and standard operating procedures of the study sponsor.

: All participants provided signed and dated informed consent prior to participation.

: Not applicable.

: F. S., J. S., M. G., Y. T. and K. H. are employees of Boehringer Ingelheim. A. S. is an employee of CRS Clinical Research Services Mannheim GmbH. I-J. J. has no conflicts of interest to declare.