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Authors
Shinkai, Masaharu
Katsumata, Noriyuki
Kawai, Shinichi
Kuyama, Shoichi
Sasaki, Osamu
Yanagita, Yasuhiro
Yoshida, Minoru
Uneda, Shima
Tsuji, Yasushi
Harada, Hidenori
Nishida, Yasunori
Sakamoto, Yasuhiro
Himeji, Daisuke
Arioka, Hitoshi
Sato, Kazuhiro
Katsuki, Ryo
Shomura, Hiroki
Nakano, Hideshi
Ohtani, Hideaki
Sasaki, Kazutaka
Adachi, Takeshi
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Article History
Received: 28 July 2023
Accepted: 6 December 2023
First Online: 29 December 2023
Declarations
:
: Masaharu Shinkai, Shoichi Kuyama, Osamu Sasaki, Yasuhiro Yanagita, Minoru Yoshida, Shima Uneda, Yasushi Tsuji, Hidenori Harada, Yasunori Nishida, Yasuhiro Sakamoto, Daisuke Himeji, Hitoshi Arioka, Kazuhiro Sato, Ryo Katsuki, and Hiroki Shomura received financial support (personal or to their institution) for this study under a clinical trial contract with Nippon Zoki. Masaharu Shinkai received writing fees from Nippon Zoki in relation to this manuscript. Noriyuki Katsumata received honoraria from Nippon Zoki as a medical expert for this study. Shinichi Kawai received research grants from Nippon Zoki and was involved in this study as a medical expert. Hideshi Nakano, Hideaki Ohtani, Kazutaka Sasaki, and Takeshi Adachi are employees of Nippon Zoki.
: This study was conducted in compliance with the Declaration of Helsinki, Good Clinical Practice, and Japanese ethical guidelines. The protocol was approved by the Institutional Review Board/Ethics Committee at all 49 institutions at which the study was conducted, including the Institutional Review Board of Tokyo Shinagawa Hospital, Medical Corporation Association, Tokyokyojuno-kai.
: All patients provided written informed consent to participate.
