Yamamoto, Eiichiro
Usuku, Hiroki
Sueta, Daisuke
Suzuki, Satoru
Nakamura, Taishi
Matsui, Kunihiko
Matsushita, Kenichi
Iwasaki, Tomoko
Sakaino, Naritsugu
Sakanashi, Toshihiko
Hirayama, Kazuto
Kurokawa, Hirofumi
Kikuta, Koichi
Yamamoto, Nobuyasu
Sato, Koji
Tokitsu, Takanori
Taguchi, Takashi
Shiosakai, Kazuhito
Sugimoto, Kotaro
Tsujita, Kenichi
,
Funding for this research was provided by:
Daiichi Sankyo Co., Ltd.
Article History
Received: 12 September 2023
Accepted: 3 January 2024
First Online: 4 February 2024
Declarations
:
: Eiichiro Yamamoto, Hiroki Usuku, Daisuke Sueta, Satoru Suzuki, Taishi Nakamura, Kunihiko Matsui, Kenichi Matsushita, Tomoko Iwasaki, Naritsugu Sakaino, Toshihiko Sakanashi, Kazuto Hirayama, Hirofumi Kurokawa, Koichi Kikuta, Nobuyasu Yamamoto, and Takanori Tokitsu have no conflicts of interest to disclose. Koji Sato has received payment or honoraria for lectures, presentations, speaker’s bureaus, manuscript writing, or educational event fees from Daiichi Sankyo Co., Ltd., Otsuka Pharmaceutical Co., Ltd., and Ono Pharmaceutical Co., Ltd. Takashi Taguchi, Kazuhito Shiosakai, and Kotaro Sugimoto are employees of Daiichi Sankyo Co., Ltd. Kenichi Tsujita has received grant fees from PPD-Shin Nippon Biomedical Laboratories K.K., Alexion Pharmaceuticals, Inc., Otsuka Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Abbott Medical Japan LLC., Bayer Yakuhin, Ltd., Nippon Boehringer Ingelheim Co., Ltd., Daiichi Sankyo Co., Ltd., and ITI Co., Ltd.; payment or honoraria for lectures, presentations, speaker’s bureaus, manuscript writing, or educational event fees from Abbott Medical Japan LLC., Amgen K.K., AstraZeneca K.K., Bayer Yakuhin, Ltd., Daiichi Sankyo Co., Ltd., Medtronic Japan Co., Ltd., Kowa Co., Ltd., Novartis Pharma K.K., Otsuka Pharmaceutical Co., Ltd., Pfizer Japan Inc., and Janssen Pharmaceutical K.K.; and has other financial or non-financial interests with Abbott Japan LLC., Boston Scientific Japan K.K., Fides-one Inc., GM Medical Co., Ltd., ITI Co., Ltd., Kaneka Medix Corp., Nipro Corp., Terumo Corp., Abbott Medical Japan LLC., Boston Scientific Japan K.K., Cardinal Health K.K., Fides-one Inc., FUKUDA DENSHI Co., Ltd., Japan Lifeline Co., Ltd., Medical Appliance Co., Ltd., and Medtronic Japan Co., Ltd.
: The protocol for this study was approved by the Kumamoto University Certified Clinical Research Review Board (CRB7200002) and prospectively registered with the Japan Registry of Clinical Trials (jRCTs071190043; ExternalRef removed). The study was conducted in accordance with the Declaration of Helsinki and the Clinical Trials Act in Japan. All the study participants provided written informed consent before enrollment.