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Authors
Son, Raku
Fujimaru, Takuya https://orcid.org/0000-0002-6825-3456
Kagimura, Tatsuo
Sofue, Tadashi
Masaki, Takao
Nakayama, Masaaki
Narita, Ichiei
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Funding
Funding for this research was provided by:
Kyowa Kirin
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Article History
Received: 18 November 2025
Accepted: 13 January 2026
First Online: 24 January 2026
Declarations
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: T.K. and I.N. received honoraria and research grants from Kyowa Kirin. The remaining authors have no conflicts of interests to disclose.
: Study approval statement: This study protocol was reviewed and approved by the institutional review board of Nagoya University (approval number: 2014–0027), which served as the main ethics committee, as well as by the ethics committees of all participating facilities. The study was conducted in accordance with the principles of the Declaration of Helsinki and the Ethical Guidelines on Clinical Studies of the Ministry of Health, Labor, and Welfare of Japan. It was also conducted under the Japanese health insurance system. The study was registered with ClinicalTrials.gov (NCT02136563) and the UMIN Clinical Trials Registry (UMIN000013464).
: Written informed consent was obtained from all participants prior to their inclusion in the study.
