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Article History

Received: 24 July 2025

Accepted: 21 October 2025

First Online: 25 November 2025

Declarations

:

: T. Kobayashi has participated in consulting or advisory roles for Astellas Pharma, AstraZeneca, Bayer, Chugai, Janssen, Medicaroid, MSD, and Nippon Kayaku; has participated in speakers bureau for Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Chugai, Janssen, Kissei, Merck, MSD, Nippon Kayaku, Nippon Shinyaku, Ono Pharmaceutical, Pfizer, Sanofi, and Takeda; and has received institutional research funding from Astellas, AstraZeneca, Bayer, and Chugai. H. Kitamura has participated in consulting or advisory roles for Astellas, AstraZeneca, Bristol Myers Squibb, Chugai, Eisai, Ferring, J&J/Janssen, Kissei Pharmaceutical, MSD, Pfizer, and Takeda; has participated in speakers bureaus for Astellas, AstraZeneca, Bristol Myers Squibb, J&J/Janssen, Merck, MSD, Nippon Shinyaku, Sanofi, and Takeda; and has received institutional research funding from J&J/Janssen. Y. Furukawa has nothing to disclose. M. Shono and T. Ito are employees of Merck Biopharma Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA. E. Kikuchi has participated in consulting or advisory roles for Astellas, AstraZeneca, Chugai, Ferring, Janssen, Merck, and MSD; has participated in speakers bureaus for Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Chugai, Eisai, Janssen, Kyorin, Merck, MSD, Nippon Kayaku, and Takeda; and has received institutional research funding from Astellas, AstraZeneca, Bristol Myers Squibb, Chugai, Kyorin, Merck, MSD, and Nippon Kayaku.

: The study was approved by the nonprofit organization MINS. Approval number: MINS-REC-240212. .

: The study was registered on jRCT (Japan Registry of Clinical Trials). Registration number: jRCT1031240122. .