Kobayashi, Kazufumi
Ogasawara, Sadahisa
Itobayashi, Ei
Okubo, Tomomi
Itokawa, Norio
Nakamura, Kazuyoshi
Moriguchi, Michihisa
Watanabe, Shunji
Ikeda, Masafumi
Kuroda, Hidekatsu
Kawaoka, Tomokazu
Hiraoka, Atsushi
Yasui, Yutaka
Kuzuya, Teiji
Sato, Rui
Kanzaki, Hiroaki
Koroki, Keisuke
Inoue, Masanori
Nakamura, Masato
Kiyono, Soichiro
Kanogawa, Naoya
Kondo, Takayuki
Nakamoto, Shingo
Ozawa, Yoshihito
Tsuchiya, Kaoru
Atsukawa, Masanori
Aikata, Hiroshi
Aramaki, Takeshi
Oka, Shiro
Morimoto, Naoki
Kurosaki, Masayuki
Itoh, Yoshito
Izumi, Namiki
Kato, Naoya
Article History
Received: 12 March 2024
Accepted: 26 April 2024
First Online: 6 June 2024
Declarations
:
: This study followed the International Conference on Harmonization Guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki. All patients provided written informed consent. The institutional review board or ethics committee at each site approved the study protocol. The Certified Clinical Research Review Board at Chiba University approved the R-evolution trial on January 22, 2020, and approval was obtained from each participating institution (jRCTs031190236).
: Informed consent was obtained from all individual participants included in the study.
: Kazufumi Kobayashi received honoraria from Eli Lilly Japan and Chugai. Sadahisa Ogasawara received honoraria from Eli Lilly Japan and Chugai, consulting or advisory fees from Bayer, Eisai, Merck & Co., Inc., Chugai, Eli Lilly Japan, and AstraZeneca, and research grants from Bayer, Chugai, AstraZeneca, Gilead Sciences, Eli Lilly Japan, and Eisai. Kazuyoshi Nakamura received honoraria from Daiichi Sankyo and Yakult. Michihisa Moriguchi received honoraria from Eisai, Bayer, Eli Lilly Japan, AstraZeneca, Chugai, and Takeda, consulting or advisory fees from Eisai, Bayer, Eli Lilly Japan, AstraZeneca, and Chugai. Masafumi Ikeda received honoraria from Abbott Japan, AstraZeneca, Bayer, Bristol-Myers Squibb, Chugai, Eisai, Eli Lilly Japan, Gilead Sciences, Merck Sharp & Dohme, Sumitomo Dainippon, and Takeda, consulting and advisory fees from AbbVie, AstraZeneca, Bayer, Chugai, Eisai, Eli Lilly Japan, Merck Sharp & Dohme, and Ono, research funding from AstraZeneca, Bristol-Myers Squibb, Chugai, Eisai, Eli Lilly Japan, Merck Sharp & Dohme, Ono, Merck Serono, and Novartis. Atsushi Hiraoka received honoraria from Eli Lilly Japan, Chugai, AstraZeneca, Bayer, and Otsuka. Yutaka Yasui received honoraria from Eli Lilly Japan, Eisai, Chugai, and Takeda. Teiji Kuzuya received honoraria from Bayer, Eisai, Eli Lilly Japan, Takeda, AstraZeneca, and Chugai. Hiroaki Kanzaki received honoraria from Takeda and Bayer. Masanori Inoue received honoraria from AbbVie and Eisai. Masato Nakamura received honoraria from Gilead Sciences, AbbVie, Nobelpharma, Otsuka, and Kowa, and research grant from AbbVie. Takayuki Kondo received honoraria from Janssen Pharmaceutical K.K. Kaoru Tsuchiya received honoraria from Bayer, Eisai, Eli Lilly Japan, Chugai, Takeda, and AstraZeneca. Hiroshi Aikata received honoraria from Eisai and Chugai, research grant from Eisai. Naoki Morimoto received honoraria from Eisai, AbbVie, and Chugai, and research grants from Eisai and AbbVie. Masayuki Kurosaki received honoraria from Eisai, Bayer, Eli Lilly Japan, Chugai, Takeda, and AstraZeneca. Yoshito Itoh received honoraria from Eli Lilly Japan, Bayer, Eisai, Merck Sharp & Dohme, Chugai, and AstraZeneca, research grants from Eli Lilly Japan, Bayer, Eisai, Merck Sharp & Dohme, Chugai, and AstraZeneca. Namiki Izumi received honoraria from Chugai, Eisai, AstraZeneca, Takeda, and Eli Lilly Japan. Naoya Kato received honoraria from Chugai, Eli Lilly Japan, AstraZeneca, and Takeda, consulting or advisory fees from Bayer and Eisai, and research grants from Bayer, Chugai, and Eisai. The other authors have no conflicts of interest to declare.