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Article History

Received: 17 December 2024

Accepted: 24 June 2025

First Online: 9 July 2025

Declarations

:

: Shigenori Kadowaki has received research funding from Ono Pharmaceutical Co. Ltd., MSD K.K., Janssen Pharmaceutical K.K., Eli Lilly Japan K.K., DAIICHI SANKYO COMPANY, LIMITED, AstraZeneca K.K., TAIHO PHARMACEUTICAL, CO., LTD., Nobelpharma Co., Ltd., Bayer Yakuhin, Ltd., Chugai Pharmaceutical Co., Ltd., and AbbVie GK; and honoraria from Ono Pharmaceutical Co. Ltd., MSD K.K., Merck KgaA, Eli Lilly Japan K.K., Bayer Yakuhin, Ltd., Novartis Pharma K.K., TAIHO PHARMACEUTICAL, CO., LTD., DAIICHI SANKYO COMPANY, LIMITED, Bristol Myers Squibb, Chugai Pharmaceutical Co., Ltd., and Eisai Co., Ltd. Tomoyuki Otsuka has received honoraria from Bristol Myers Squibb and Ono Pharmaceutical Co. Ltd. Keiko Minashi has received research funding from Bristol Myers Squibb, Ono Pharmaceutical Co. Ltd., TAIHO PHARMACEUTICAL, CO., LTD., DAIICHI SANKYO COMPANY, LIMITED, and MSD K.K.; and honoraria from Bristol Myers Squibb and Ono Pharmaceutical Co. Ltd. Shinichi Nishina has received from Bristol Myers Squibb and Ono Pharmaceutical Co. Ltd. Hiroshi Yabusaki has no conflict of interest. Chiaki Inagaki has received honoraria from Bristol Myers Squibb, Ono Pharmaceutical Co. Ltd., DAIICHI SANKYO COMPANY, LIMITED, Takeda Pharmaceutical Co., Ltd., and Astellas Pharma Inc. Tomohiro Nishina has received honoraria from Bristol Myers Squibb, Ono Pharmaceutical Co. Ltd., TAIHO PHARMACEUTICAL, CO., LTD., Eli Lilly Japan K.K., DAIICHI SANKYO COMPANY, LIMITED, Astellas Pharma Inc., and MSD K.K. Hisateru Yasui has received research funding from Ono Pharmaceutical Co. Ltd.; and honoraria from Bristol Myers Squibb, TAIHO PHARMACEUTICAL, CO., LTD., Chugai Pharmaceutical Co., Ltd., and Yakult Honsha Co., Ltd. Hiroshi Matsuoka has received honoraria from Bristol Myers Squibb and DAIICHI SANKYO COMPANY, LIMITED. Nozomu Machida has received honoraria from Bristol Myers Squibb and Ono Pharmaceutical Co. Ltd. Masahiro Tsuda has received honoraria from Eli Lilly Japan K.K., Ono Pharmaceutical Co. Ltd., Bristol Myers Squibb, and MSD K.K. Fumio Nagashima has received honoraria from TAIHO PHARMACEUTICAL, CO., LTD., Ono Pharmaceutical Co. Ltd., Chugai Pharmaceutical Co., Ltd., Yakult Honsha Co., Ltd., DAIICHI SANKYO COMPANY, LIMITED, Merck Biopharma Co., Ltd., Janssen Pharmaceutical K.K., and Takeda Pharmaceutical Co., Ltd. Hisashi Hosaka has no conflict of interest. Junichi Matsubara has no conflict of interest. Hiroyuki Arai has received research funding from Novartis Pharma K.K. and honoraria from Bristol Myers Squibb. Satoshi Ida has no conflict of interest. Yuya Kimijima is an employee of Bristol Myers Squibb. Yuko Matsuda is an employee of Ono Pharmaceutical Co. Ltd. Manabu Muto has received research funding from Ono Pharmaceutical Co. Ltd. and Meiji Seika Pharma Co., Ltd.; and honoraria from Chugai Pharmaceutical Co., Ltd., MSD K.K., AstraZeneca K.K., Ono Pharmaceutical Co. Ltd., and Meiji Seika Pharma Co., Ltd. Kei Muro has received research funding from Amgen Inc., Ono Pharmaceutical Co. Ltd., Astellas Pharma Inc., Sanofi K.K., TAIHO PHARMACEUTICAL, CO., LTD., PRA Health Sciences, Inc., Parexel International Inc., Novartis Pharma K.K., Chugai Pharmaceutical Co., Ltd., and MSD K.K.; consulting fees from Amgen Inc., AstraZeneca K.K., Ono Pharmaceutical Co. Ltd., Astellas Pharma Inc., and Chugai Pharmaceutical Co., Ltd.; honoraria from Ono Pharmaceutical Co. Ltd., TAIHO PHARMACEUTICAL, CO., LTD., Bristol Myers Squibb, Eli Lilly Japan K.K., MSD K.K., Takeda Pharmaceutical Co., Ltd., and DAIICHI SANKYO COMPANY, LIMITED; and served as a member of the Data Safety Monitoring Board or Advisory Board for Astellas Pharma Inc., Amgen Inc., AstraZeneca K.K., and Takeda Pharmaceutical Co., Ltd.

: This study was approved by Non-Profit Organization MINS Research Ethics Committee (MINS-REC-220205) and was conducted in compliance with the Japanese Ethical Guidelines for Medical and Health Research Involving Human Subjects and the Act on the Protection of Personal Information. All study procedures were conducted in accordance with the principles of the World Medical Association Declaration of Helsinki.

: The authors thank the patients and families who are making the study possible and the investigators at the centers participating in the study. The authors also thank the clinical study teams. The data system was provided by Prime Research Institute for Medical RWD, Inc. Writing and editorial assistance was provided by Mebix, Inc., funded by Bristol Myers Squibb and Ono Pharmaceutical Co., Ltd.