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Article History

Received: 26 March 2025

Accepted: 22 June 2025

First Online: 18 July 2025

Declarations

:

: The study was registered under UMIN-CTR as UMIN000051639, on July 19, 2023. The study protocol was approved by Non-Profit Organization MINS IRB, on June 22 (Registration number: 230216).

: Informed consent was obtained from all subjects involved in the study.

: Y.U. reports consultancy for Alexion, Asahi Kasei, Chugai, Janssen, Novartis, Ono, and Sanofi; speakers’ bureau fees from Alexion, Incyte Biosciences Japan, Janssen, Sanofi, and Sobi; advisor for Alexion, Janssen, and Novartis; research funding from Chugai; honoraria from Chugai, Kaken, and Nippon Shinyaku. N.O. reports honoraria from Alexion, Novartis, Sobi, Chugai/F. Hoffmann-La Roche Ltd, and Kyowa Kirin; research funding from Alexion. S.U. reports speakers’ bureau fees from Chugai, Sobi Japan, Asahi Kasei, Alexion and Novartis. K.H. has no disclosures to declare. M.S. reports honoraria from Chugai, Alexion, Asahi Kasei, and Novartis. T.M. and Y.F. are employees at CRECON Medical Assessment Inc. N.H. and M.Y. are employees at Chugai. Y.O. reports research funding from Mochida and FUJIFILM; honoraria from AstraZeneca, Chugai, SymBio, Pfizer Japan, Kyowa Kirin, Novartis, Novo Nordisk, Meiji Seika, Otsuka, CSL Behring, Sanofi, Daiichi Sankyo, Nippon Kayaku, Bristol Myers Squibb, Bayer Yakuhin, Takeda, Zeria, Eisai, AbbVie, Alexion, Nipro, and PharmaEssentia Japan; other support (clinical trials) from Novartis, Mochida, Janssen, Bristol Myers Squibb, MSD, Shionogi, Meiji Seika, AbbVie, Labcorp Development Japan, Chugai, Kyowa Kirin, Astellas, Shionogi Healthcare Clinical, Otsuka, IQVIA Services Japan, Parexel International, Incyte Biosciences Japan, Sumitomo, ICON Japan, Ono, and Daiichi Sankyo. K.U. has received research funding from Agios, Astellas, AbbVie, Alexion, Aperis, Asahi Kasei, Bristol Myers Squibb, Celgene, Chugai, Daiichi Sankyo, Eisai, Gilead, Incyte, Kyowa Kirin, MSD, Nippon Shinyaku, Novartis, Ohara, Ono, Otsuka, PharmaEssentia, Pfizer, Sanofi, Takeda, and Yakult; speakers’ bureau fees from AbbVie, Alexion, Amgen, Astellas, Asahi Kasei Pharma, AstraZeneca, Bristol Myers Squibb, Chugai, Eisai, Incyte, Kyowa Kirin, Meiji Seika Pharma, Novartis, Sanofi, Nippon Shinyaku, Ono, Otsuka, Pfizer, Sando, PharmaEssentia, Sanofi, Takeda, and Janssen; consulting bureau fees from Alnylam Japan, Ohara, and Chugai. T.I. reports consultancy for Chugai, Nippon Shinyaku, Asahi Kasei, and Alexion; honoraria from Asahi Kasei, Alexion, Sanofi, and Nippon; research funding from Asahi Kasei; scholarship donations from Asahi Kasei, Nippon Shinyaku, Astellas, AbbVie, Otsuka, Takeda, Novartis, and Janssen. T.K. reports honoraria from Alexion and Chugai. N.H. reports honoraria from Chugai, Janssen, Bristol Myers Squibb, Takeda, and Novartis; research funding from Otsuka, Chugai, and Shionogi. Y.K. reports scholarship donations from Chugai, Kyowa Kirin, Shionogi, Asahi Kasei, Otsuka, and Takeda. A.G. reports honoraria from Novartis, Alexion, Eisai, Ono, Taiho, Takeda, Nippon Shinyaku, Chugai, Otsuka, Sumitomo Dainippon, Daiichi Sankyo, Nihon, Kyowa Kirin, Janssen, Pfizer Japan, Sanofi, Asahi Kasei, and PharmaEssentia Japan; consulting fees from PharmaEssentia Japan, Chugai, Alexion, and Asahi Kasei; advisor for PharmaEssentia Japan, Chugai, Alexion, and Asahi Kasei; research funding from Asahi Kasei, Ono, Taiho, Chugai, and Otsuka. J.N. reports honoraria from Chugai, F. Hoffmann-La Roche Ltd, Alexion, Novartis, Sobi, and Sanofi.