Motoki, Hirohiko
Inobe, Yoshito
Fukui, Toshiki
Iwasaki, Arata
Hiramitsu, Shinya
Koyama, Sekiya
Masuda, Izuru
Sekimura, Noriyuki
Yamamoto, Kazuya
Sato, Ai
Komatsu, Mitsuhisa
Taguchi, Takashi
Shiosakai, Kazuhito
Sugimoto, Kotaro
Kuwahara, Koichiro
Funding for this research was provided by:
Daiichi-Sankyo
Article History
Received: 19 December 2022
Accepted: 1 August 2023
First Online: 21 September 2023
Declarations
:
: Hirohiko Motoki has received lecture fees from Alnylam Japan K.K., AstraZeneca K.K., Amgen Astellas BioPharma K.K., MSD K.K., Otsuka Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Factory, Inc., Ono Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., GlaxoSmithKline K.K., Sanofi K.K., Daiichi Sankyo Co., Ltd., Mitsubishi Tanabe Pharma Corp., Chugai Pharmaceutical Co., Ltd., Toa Eiyo Ltd., Nippon Shinyaku Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Novartis Pharma K.K., Bayer Yakuhin, Ltd., Pfizer Japan Inc., and Janssen Pharmaceutical K.K., and his affiliated institution (Shinshu University School of Medicine) has received grants from Astellas Pharma Inc., Kissei Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Nippon Shinyaku Co., Ltd., Bayer Yakuhin, Ltd., Pfizer Japan Inc., and Janssen Pharmaceutical K.K. outside the submitted work. Arata Iwasaki has received lecture fees from Takeda Pharmaceutical Co., Ltd., MSD K.K., Kowa Co., Ltd., Teijin Home Healthcare Ltd., Sumitomo Dainippon Pharma Co., Ltd. (Sumitomo Pharma Co., Ltd.), Astellas Pharma Inc., and AstraZeneca K.K. outside the submitted work. Shinya Hiramitsu has received lecture fees from Daiichi Sankyo Co., Ltd. outside the submitted work. Izuru Masuda has received lecture fees from Takeda Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Novartis Pharma K.K., and Otsuka Pharmaceutical Co., Ltd. outside the submitted work. Mitsuhisa Komatsu has received lecture fees from Sumitomo Pharma Co., Ltd., Novo Nordisk Pharma Ltd., Eli Lilly Japan K.K., Sanofi K.K., Takeda Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., MSD K.K., Astellas Pharma Inc., and Nippon Boehringer Ingelheim Co., Ltd., and has received grants from Novo Nordisk Pharma Ltd., Takeda Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Sumitomo Pharma Co., Ltd., Sanofi K.K., Abbott Japan LLC, Kowa Co., Ltd., MSD K.K., Eli Lilly Japan K.K., and Kissei Pharmaceutical Co., Ltd.; consulting fees from Novo Nordisk Pharma Ltd., and Eli Lilly Japan K.K. outside the submitted work. Takashi Taguchi, Kazuhito Shiosakai, and Kotaro Sugimoto are employees of Daiichi Sankyo Co., Ltd. Koichiro Kuwahara has received consulting fees from AstraZeneca K.K., Daiichi Sankyo Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Bayer Yakuhin, Ltd.; lecture fees from Alnylam Japan K.K., Astellas Pharma Inc., AstraZeneca K.K., Amgen K.K., Viatris Inc., Eisai Co., Ltd., MSD K.K., Otsuka Pharmaceutical Co., Ltd., Otsuka Pharmaceutical Factory, Inc., Ono Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., GlaxoSmithKline K.K., Kowa Co., Ltd., Shionogi & Co., Ltd., Sanofi K.K., Taisho Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd. (Sumitomo Pharma Co., Ltd.), Takeda Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corp., Toa Eiyo Ltd., Nabelin Co., Ltd., Eli Lilly Japan K.K., Nippon Shinyaku Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Novartis Pharma K.K., Novo Nordisk Pharma Ltd., Bayer Yakuhin, Ltd., Pfizer Japan Inc., Bristol-Myers Squibb K.K., Mochida Pharmaceutical Co., Ltd., and Janssen Pharmaceutical K.K., and his affiliated institution (Shinshu University School of Medicine) has received grants from Actelion Pharmaceuticals Japan Ltd., Astellas Pharma Inc., AstraZeneca K.K., MSD K.K., Otsuka Pharmaceutical Co., Ltd., Kyowa Kirin Co., Ltd., Kowa Co., Ltd., Sanofi K.K., ZERIA Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd., Taisho Pharmaceutical Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd. (Sumitomo Pharma Co., Ltd.), Takeda Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corp., Teijin Pharma Ltd., Eli Lilly Japan K.K., Nippon Shinyaku Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Novo Nordisk Pharma Ltd., Mochida Pharmaceutical Co., Ltd., and Janssen Pharmaceutical K.K. outside the submitted work. Yoshito Inobe, Toshiki Fukui, Sekiya Koyama, Noriyuki Sekimura, Kazuya Yamamoto and Ai Sato have no conflicts of interest to declare.
: This study was conducted in accordance with the principles of the Declaration of Helsinki and the Clinical Trials Act in Japan. The study protocol was approved by the Shinshu University Certified Review Board of Clinical Research (CRB3200010). The study was prospectively registered with the Japan Registry of Clinical Trials under the identifier number jRCTs031200273. All patients provided written informed consent before enrollment.
: All authors fulfilled the International Committee of Medical Journal Editors (ICMJE) criteria for authorship, take responsibility for the integrity of the work, and have given their approval for this version to be published.