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Article History

Received: 11 April 2025

Accepted: 15 June 2025

First Online: 24 June 2025

Declarations

:

: The study protocol was approved by the Nagoya University Certified Review Board (2021–0079) and registered in the Japanese Registry of Clinical Trials (jRCT s041210024). The study was conducted in compliance with the principles of the Declaration of Helsinki and Ministry of Health, Labour and Welfare regulations.

: All participants agreed to the purpose and procedures of this study and provided written consent prior to the starting.

: All participants agreed to the publish of this study and provided written consent prior to the starting.

: AF and YK are employees of Eisai Co., Ltd. KI reports personal fees from Eisai, Lundbeck Japan, MSD, Otsuka, Sumitomo Pharma, Takeda, Viatris, and DAIICHI SANKYO, outside the submitted work. NO has received research support or speaker honoraria from, or has served as a joint researcher with, or a consultant to, Otsuka Pharmaceutical Co., Ltd., Sumitomo Pharma Co., Ltd., Viatris Inc., Eisai Co., Ltd., The KAITEKI Institute, Inc., Ricoh Co., Ltd., and Mitsubishi Tanabe Pharma Co.; reports personal fees/grants from Eli Lilly, DAIICHI SANKYO, TSUMURA, Takeda, Mochida, Meiji Seika Pharma, EA Pharma, Viatris, Ricoh, Nippon Boehringer Ingelheim, Lundbeck Japan, Nihon Medi-Physics, and Nippon Chemiphar, outside the submitted work. MI has received speaker’s honoraria from Meiji Seika Pharma, Otsuka Pharmaceutical, Takeda Pharmaceuticals, Lundbeck Japan KK, Mochida Pharmaceutical, Jansen Pharmaceutica KK, Tanabe Mitsubishi Pharma, MSD, Eisai, Kyowa Pharma Chemical, Towa Pharmaceutical, and Viatris. The other authors report no other conflicts of interest in this work.