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Article History

Received: 13 September 2025

Accepted: 7 November 2025

First Online: 5 December 2025

Declarations

:

: The study protocol was approved centrally by the Certified Review Board of Fukushima Medical University (no. F2023001), and the trial adhered to the principles of the Declaration of Helsinki and the Clinical Trial Act in Japan. Written informed consent was obtained from all participants.

: Not applicable.

: A.T. has received honoraria from Boehringer Ingelheim Japan, Mochida, and Amgen and research funding from Bristol Myers Squibb; A.T. is an Editorial Board member of the journal and not involved in handling this manuscript during the submission and review processes. M.V. has received research grant support, served on advisory boards or had speaker engagements with American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Bristol Myers Squibb, Boehringer Ingelheim, Chiesi, Cytokinetics, Fresenius Medical Care, Idorsia Pharmaceuticals, Lexicon Pharmaceuticals, Merck, Milestone Pharmaceuticals, Novartis, Novo Nordisk, Pharmacosmos, Relypsa, Roche Diagnostics, Sanofi and Tricog Health and participates on clinical trial committees for studies sponsored by Amgen, AstraZeneca, Galmed, Novartis, Bayer AG, Occlutech and Impulse Dynamics. T.I. has received lecture fees from Kyowa Kirin and Eizai Pharmaceutical and has served as a statistician in the Organization for Clinical Medicine Promotion. S.Suwa. has received honoraria from Abbott Medical Japan and Daiichi Sankyo. H.T. has received honoraria from Abbott Medical Japan, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Kowa, Medtronic, and Nihon Medi-Physics. M.Miyazono. has received honoraria from Chugai Pharmaceutical, Astellas, Kyowa Kirin, Mitsubishi Tanabe, Mochida Pharmaceutical, AstraZeneca, Bayer Yakuhin, Torii Pharmaceutical, Fuso Pharmaceutical Industries, Daiichi Sankyo Company, Limited, Teijin Pharma, Eli Lilly Japan K.K., Nippon Boehringer Ingelheim Co., Ltd., and Kissei Pharmaceutical; research funding from Chugai Pharmaceutical and Kyowa Kirin; and scholarships from Kyowa Kirin, Torii Pharmaceutical, Fuso Pharmaceutical Industries, and Kissei Pharmaceutical. N.T. received honoraria from Daiichi Sankyo, Novartis Pharma, Bristol Myers Squibb, Pfizer, Otsuka Pharmaceutical, Medtronic, Toa Eiyo, and Nippon Boehringer-Ingelheim. M.S. has received honoraria from Bayer Yakuhin, Ltd. MMoroi has received honoraria from Sanofi, Amicus Therapeutics, Takeda, Otsuka, Kowa, Mitsubishi Tanabe Pharma, Daiichi Sankyo, Astra Zeneca, Nihon Medi-physics, and Bayer and research funding from Taisho Pharmaceutical. K.K. received honorariums from AstraZeneca K.K., Ono Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Bayer Yakuhin, Ltd., Otsuka Pharmaceutical Co., Ltd., and Novartis Pharmaceuticals Co., Ltd. D.F. received research funding from AMGEN Inc. and BIOTRONIK Japan, Inc.; honoraria from Novartis Pharma K.K., Otsuka Pharmaceutical Co., Ltd., and Kowa Company, Ltd. K.Tanabe. has received honoraria from Kowa, Boehringer-Ingelheim, Daiichi Sankyo, Toa Eiyo, Eli Lilly, Novartis, Novo Nordisk, Bayer, Pfizer, AstraZeneca, Ono pharma, Otsuka, and Takeda. Y.Horiuchi. has received honoraria from Bayer Pharmaceuticals and research funding from Asahi Intecc. H.Y. has received outsourcing fees from the organization for Clinical Medicine Promotion. T.M. has received honoraria from Kowa, Novartis Japan and AstraZeneca and research funding from Kowa. M.N. has received honoraria and advisory fees from Boehringer Ingelheim, Kyowa Kirin, Astellas, Astra Zeneca, GSK, Daiichi Sankyo, Tanabe-Mitsubishi, Chugai, Torii, JT, and Novo Nordisk and research funding from Kyowa-Kirin, Daiichi Sankyo, Astellas, Ono, Tanabe-Mitsubishi, JT, Chugai, Bayer, Torii, and Takeda. H.S. has received honoraria from Bayer and Daiichi Sankyo, Japan. K.N. has received honoraria from AstraZeneca, Bayer, Boehringer Ingelheim Japan, Daiichi Sankyo, Kowa, Mochida, MSD, Novartis, Novo Nordisk, and Otsuka; research grants from Astellas, Bayer, ðFujiyakuhin, Mochida, Novartis; scholarship from Abbott, Boehringer Ingelheim Japan, and Teijin. All other authors declare no competing interests.