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Article History

Received: 3 March 2025

Accepted: 23 July 2025

First Online: 24 September 2025

Declarations

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: Yoshio Tsuboi received consulting fees and support for attending meetings and/or travel from Kyowa Kirin; and has received payments or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from Sumitomo Pharma, Takeda Pharmaceutical, and Eisai. Yasushi Shimo received honoraria from Kyowa Kirin; and has received honoraria from Takeda Pharmaceutical, AbbVie, Otsuka Pharmaceutical, Sumitomo Pharma, Boston Scientific, Medtronic, FP Pharmaceutical, and Ono Pharmaceutical. Kenichi Kashihara received consulting fees and honoraria from Kyowa Kirin; and has received honoraria from Sumitomo Pharma and Takeda Pharmaceutical. Shih-Wei Chiu received support for the present manuscript from Kyowa Kirin. Takuhiro Yamaguchi received support for the present manuscript from Kyowa Kirin; and has received grants from AC Medical, A2 Healthcare, ClinChoice, Japan Tobacco, Japan Media, Medidata Solutions, Ono Pharmaceutical, Medrio, NIPRO, intellim, Welby, 3H Medi Solution, Baseconnect, NOBORI, Puravida Technologies, Hemp Kitchen, Tsumura & Co., Daiichi Sankyo, Otsuka Pharmaceutical, Solasia Pharma, Cordis, and NTT DOCOMO; consulting fees from Public Health Research Foundation, EPS, Japan Tobacco, Medidata Solutions, Ono Pharmaceutical, Kowa Company, Chugai Pharmaceutical, Daiichi Sankyo, Eisai, 3H Clinical Trial, intellim, AstraZeneca, Sonire Therapeutics, Seikagaku, Merck & Co., Mebix, and Nippon Boehringer Ingelheim; and participated on an advisory board for Incyte Biosciences Japan. Takafumi Hasegawa, Satoshi Kaneko, and Masahiko Tomiyama have nothing to declare.

: This RCT was performed in compliance with the Declaration of Helsinki and the Clinical Research Act of Japan (Act No. 16 of 2017). It was approved by the Fukuoka University Medical Ethics Review Board (December 1, 2016, approval ID 2016M020), the Clinical Research Network Fukuoka Certified Review Board (October 31, 2018, approval ID 18-C08), and the responsible ethics committee/institutional review board at all of the participating sites listed in the Supplementary Materials. The RCT was registered on the University hospital Medical Information Network clinical trials registry (identifier UMIN000024536; ; October 25, 2016) and Japan Registry of Clinical Trials (identifier jRCTs071180014; ; January 29, 2019). All data were collected and processed anonymously at a central site (Clinical Trial Data Center, Tohoku University Hospital). Written informed consent to participate was provided by the patients or by their representative once the patient had provided oral consent. We confirm that we have read the Journal’s position on issues involved in ethical publication and affirm that this work is consistent with those guidelines.