Takahashi, Akiko https://orcid.org/0009-0006-4275-4654
Ishii, Manabu https://orcid.org/0009-0008-3406-2150
Kino, Yurika https://orcid.org/0009-0007-5725-4940
Sasaki, Kazuyo https://orcid.org/0000-0001-5267-8284
Matsui, Takahiro
Arakawa, Kenji https://orcid.org/0000-0001-9900-9491
Kunisaki, Makoto https://orcid.org/0009-0005-8188-5895
Funding for this research was provided by:
Mitsubishi Tanabe Pharma Corporation
Article History
Received: 28 December 2023
Accepted: 7 February 2024
First Online: 30 March 2024
Declarations
:
: Makoto Kunisaki has received clinical commissioned study fees from Mitsubishi Tanabe Pharma Corporation and Novo Nordisk Pharma Ltd. Akiko Takahashi, Manabu Ishii, Yurika Kino, Kazuyo Sasaki, Takahiro Matsui, and Kenji Arakawa are employees of Mitsubishi Tanabe Pharma Corporation.
: All procedures were conducted in accordance with the Declaration of Helsinki and the local regulations. All participants gave written informed consent. Site monitoring was conducted by EPS Corporation (Tokyo, Japan). Since the study site did not have its own ethical review body, this study was reviewed and approved by the certified ethical review committee established by Saga Memorial Hospital (ID. 16000061). The study was registered in the Japan Registry of Clinical Trials (jRCT ID: 1070220007).