Nakamura, Michio
Funakoshi, Taro
Kataoka, Shigeki
Horimatsu, Takahiro
Nishikawa, Yoshitaka
Matsubara, Takeshi
Mizukami, Takuro
Goto, Tomoyuki
Tsuchihashi, Kenji
Baba, Eishi
Tsumura, Takehiko
Mihara, Yoshiaki
Hamaguchi, Tetsuya
Yanagita, Motoko
Muto, Manabu
Article History
Received: 24 November 2021
Accepted: 26 April 2022
First Online: 7 May 2022
Declarations
:
: This study was carried out in accordance with the Declaration of Helsinki, the Japanese Ethical Guidelines on Clinical Research, and the Ethical Guidelines for Clinical Studies, and was registered with the University Hospital Medical Information Network (UMIN) Clinical Trials Registry (protocol ID ExternalRef removed,). Protocol approval was obtained from Kyoto University Graduate School and Faculty of Medicine, Ethics Committee (Approval number and date: R1498, 11/June/2019) and also obtained from the clinical research ethics review board of all participating institutions. All living participants signed an informed consent form allowing their data to be used in this study. We announced that the opportunity to opt-out is always available to all participants via a website and posters on hospital walls.
: Not applicable.
: MN, YM, MY, and MM have received honoraria from Chugai Pharmaceutical. MN and EB have received honoraria from Eli Lilly Japan. MN has honoraria from Sanofi. EB has received a Chugai scholarship donation. MY, and MM have received a donation from Chugai Pharmaceutical. TF and MM belong to a donated course in Chugai Pharmaceutical. MM has received a donation from Sanofi. MM has received institutional research funding from Chugai Pharmaceutical. SK, TH, TM, TM, TG, KT, TT, and TH declare that they have no conflict of interest.