Araki, Tomonori
Sonoda, Yuki
Shimokawa, Mototsugu
Otsuka, Taiga
Hayashi, Kohei
Honda, Takuya
Nakao, Kazuhiko
Shibuki, Taro
Nakazawa, Junichi
Arima, Shiho
Miwa, Keisuke
Okabe, Yoshinobu
Koga, Futa
Ueda, Yujiro
Kubotsu, Yoshihito
Shimokawa, Hozumi
Takeshita, Shigeyuki
Komori, Azusa
Nishikawa, Kazuo
Otsu, Satoshi
Hosokawa, Ayumu
Oda, Hisanobu
Sakai, Tatsunori
Arita, Shuji
Kawahira, Machiko
Taguchi, Hiroki
Tsuneyoshi, Kengo
Kawaguchi, Yasunori
Fujita, Toshihiro
Sakae, Takahiro
Shirakawa, Tsuyoshi https://orcid.org/0000-0002-9317-8216
Mizuta, Toshihiko
Mitsugi, Kenji
Funding for this research was provided by:
Taiho Pharmaceutical
Chugai Pharmaceutical
Article History
Received: 29 September 2023
Accepted: 23 January 2025
First Online: 27 January 2025
Declarations
:
: AH reports honoraria from Taiho, Ono, Eisai, Chugai, Lilly, Daiichi Sankyo, Yakult, and Nippon Zoki. There are no competing interests or financial disclosures for the remaining authors to report.
: Given that this study only utilized existing information and did not involve obtaining new samples or data, formal written or oral informed consent was not needed from the participants in compliance with the principles of the Declaration of Helsinki and the relevant Japanese laws regarding human subject research (Clinical Trials Act), the Institutional Review Boards of the participating institutions approved that formal written or verbal informed consent from participants was not required. However, the Law assures that patients or their proxies have the opportunity to decline participation in the investigation by refusing to be included if the research details were disclosed on the participating institutions’ websites. The study protocol was approved by the central approval of the Institutional review board of Sasebo Kyosai Hospital (Study ID 2021-08), and also with the approval of the Institutional review boards or ethics committees of the following institutions: Nagasaki University Hospital, Kagoshima City Hospital, National Cancer Center Hospital East, Kagoshima University Hospital, Kurume University Hospital, Saga Medical Center Koseikan, Japanese Red Cross Kumamoto Hospital, Karatsu Red Cross Hospital, Japan Community Healthcare Organization Kyushu Hospital, Japanese Red Cross Nagasaki Genbaku Hospital, Oita University Hospital, University of Miyazaki Hospital, National Hospital Organization Kumamoto Medical Center, Saiseikai Kumamoto Hospital, Kagoshima Kouseiren Hospital, Miyazaki Prefectural Miyazaki Hospital, Izumi General Medical Center, Asakura Medical Association Hospital, and Saiseikai Sendai Hospital. All of the hospitals judged that the need for informed consent could be waived in compliance with the Japanese laws.
: The requirement for consent for publication was obtained using the opt-in/opt-out approach according to each participating institution’s policy.