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Authors
Mizuno, Katsumi
Miyazawa, Tokuo
Kondo, Utako
Nishikubo, Toshiya
Yamamoto, Yutaka
Nakano, Yuya
Hiroma, Takehiko
Ikeda, Kazushige https://orcid.org/0000-0002-3097-2156
Murase, Masahiko https://orcid.org/0009-0001-6795-2669
Jimi, Hitomi
Hokuto, Isamu
Miyata, Masafumi https://orcid.org/0000-0003-0460-1164
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Article History
Received: 7 April 2025
Revised: 18 March 2026
Accepted: 10 April 2026
First Online: 27 April 2026
Competing interests
: The authors declare no competing interests.
: This study was conducted with strict adherence to the ethical principles outlined in Good Clinical Practice and the standards set by the International Council for Harmonisation (ICH) Tripartite Guideline, as well as the Japan Good Clinical Practice regulations. Moreover, this trial upholds the ethical considerations and patient rights stipulated in the Declaration of Helsinki and was performed in accordance with the ethical standards of the Independent Ethics Committee at each participating site, which approved all related materials and informed consent forms, as follows: 1. Showa Medical University Hospital Institutional Review Board. 2. Showa Medical University Koto Toyosu Hospital Institutional Review Board. 3. Showa Medical University Northern Yokohama Hospital Institutional Review Board. 4. Nara Medical University Hospital Institutional Review Board. 5. Saitama City Hospital Institutional Review Board. 6. The Central Institutional Review Board for the Fujita Health University Hospitals. 7. Bokutoh Hospital Clinical Trial Review Committee. 8. Review Board of Human Rights and Ethics for Clinical Studies. 9. Social Medical Corporation Aijinkai Group Takatsuki General Hospital Institutional Review Board. 10. Gifu Prefectural General Medical Center Institutional Review Board. 11. St. Marianna University Group Institutional Review Board.
