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Article History

Received: 20 October 2024

Accepted: 19 February 2025

First Online: 26 February 2025

Declarations

:

: This study was approved by the Ethics Committee of Hokkaido University Hospital (approval number: 022–0109). It has been registered in the Japan Registry of Clinical Trials as jRCT1010220025 since November 7, 2022. All researchers involved in this study will comply with the Declaration of Helsinki and the Ethical Guidelines for Medical Research Involving Human Subjects. For retrospective observation (Fig. A), participants have the opportunity to opt out of the study. Information regarding the study is disclosed on the webpage of each participating facility. For the prospective observation (Fig. B C), written informed consent was obtained from all patients before prospective study procedures were performed.

: Study participants are informed that their anonymized data will be published in academic journals and provide the written consent form for publication.

: This study will be conducted fairly by the principal researcher (and group) of this university and will be funded by Janssen Pharmaceutical K.K. Approval for conflicts of interest in this study has been obtained from the Conflict-of-Interest Committee of Hokkaido University Hospital, ensuring fairness. H Hanaoka has received speaking fees from Asahi-Kasei, Chugai, Astellas, and Eli Lilly. A Hashimoto has received speaking fees from Eisai, Janssen, Mochida Pharmaceutical, Nippon Shinyaku, Daiichi Sankyo Company. M Kuwana has received research grants from MBL, consultant/speaking fees from Asahi-Kasei, AstraZeneca, Boehringer-Ingelheim, Chugai, GSK, Janssen, Kissei, MBL, Mochida, and Ono Pharmaceuticals. T Higuchi has received speaking fees or consulting fees from Chugai, Pfizer, Boehringer, Asahi Kasei, Gilead, Eli Lilly, Janssen, and RIBOMIC, and belongs to an endowment department that is supported with an unrestricted grant from Ayumi, Asahi Kasei, Taisho, Mochida, Chugai, and AbbVie. YM Ito is a member of Independent Data Monitoring Committee of Janssen Pharmaceutical K.K. R. Hisada has received speaking fees from AbbVie Inc., Asahi-Kasei Co., Astellas Pharma Inc., Ayumi Pharmaceutical Co., Bristol-Myers Squibb Co., Chugai Pharmaceutical Co., Ltd.; Daiichi Sankyo Co., Ltd., Eisai Co. Ltd., Janssen Pharmaceutical K.K., Nippon Boehringer Ingelheim Co., Mitsubishi Tanabe Pharma Co., Otsuka Pharmaceutical Co., Ltd., Pfizer Inc. T Atsumi has received research grants from Astellas, Takeda, Mitsubishi Tanabe, Chugai, Daiichi-Sankyo, Otsuka, Pfizer, Alexion, Bayer, Otsuka, Chugai, Takeda, Eisai, Bristol-Myers Squibb, Daiichi Sankyo, Mitsubishi Tanabe, and Asahi Kasei; consultant fees from Ono, Sanofi, Daiichi Sankyo, and Pfizer; and speaking fees from Mitsubishi Tanabe, Chugai, Astellas, Takeda, Pfizer, Daiichi Sankyo, Bristol-Myers Squibb, and Eli Lilly. M Kato has received research grants from AbbVie, Actelion, GlaxoSmithKline, Janssen, Nippon Shinyaku, and Novartis, and speaking fees from Astellas, Boehringer, Eisai, Eli Lilly, Janssen, Mitsubishi Tanabe, and Pfizer. The other authors have nothing to declare.