Otoda, Toshiki http://orcid.org/0000-0003-2244-3403
Sekine, Akiko
Uemoto, Ryoko
Tsuji, Seijiro
Hara, Tomoyo
Tamaki, Motoyuki
Yuasa, Tomoyuki http://orcid.org/0000-0002-5598-6781
Tamaki, Toshiaki http://orcid.org/0000-0003-0362-9966
Matsuhisa, Munehide http://orcid.org/0000-0003-4624-939X
Aihara, Ken-ichi http://orcid.org/0000-0001-8906-0920
Funding for this research was provided by:
Japan Society for the Promotion of Science KAKENHI (18K16204)
Article History
Received: 12 August 2023
Accepted: 6 October 2023
First Online: 26 October 2023
Declarations
:
: Toshiki Otoda received lecture fees from Taisho Pharmaceutical Holdings Co., Ltd. and Kowa Company, Ltd. and received speaker fees from Astellas Pharma, Inc., Nippon Boehringer Ingelheim Co., Ltd., and Mitsubishi Tanabe Pharma Corporation. Motoyuki Tamaki received speaker fees from Eli Lilly Japan K.K. Tomoyuki Yuasa received speaker fees from Eli Lilly Japan K.K., Nippon Boehringer Ingelheim Co., Ltd., and Mitsubishi Tanabe Pharma Corporation. Toshiaki Tamaki received speaker fees from Astellas Pharma, Inc., Ono Pharmaceutical Co., Ltd., and Mitsubishi Tanabe Pharma Corporation. Munehide Matsuhisa received speaker fees from Nippon Boehringer Ingelheim Co., Ltd., Eli Lilly Japan K.K., Novo Nordisk Pharma Ltd., Sumitomo Pharma Co., Ltd., Sanofi K.K., and Kyowa Kirin Co., Ltd. Akiko Sekine, Ryoko Uemoto, Seijiro Tsuji, Tomoyo Hara, and Ken-ichi Aihara declare that they have no conflicts of interest to disclose.
: This study complied with the Declaration of Helsinki and Good Clinical Practice guidelines and was conducted as a collaborative multicenter research effort led by Tokushima University. To ensure comprehensive ethical approval across all participating facilities, each institution sought a consolidated review by the Institutional Review Board of Tokushima University Hospital. Subsequently, the Institutional Review Board of Tokushima University Hospital granted approval for all study sites involved in this multicenter study (approval date April 23, 2018; approval ID 3149). The research proceeded after securing the necessary approvals from each research institution. Additional matters requiring approval, such as protocol amendments, were evaluated and approved by the institutional review boards on the basis of need. The trial was registered with the University Hospital Medical Information Network (UMIN No. 000031947). The patients were provided with detailed explanations of the study protocol. All participants provided written informed consent for participation in the study and for publication of the study results. Nonetheless, all patient records and information were anonymized before the analysis.