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Article History

Accepted: 5 October 2023

First Online: 7 November 2023

Declarations

:

: This work was funded by Astellas Pharma, Inc.

: Kentaro Watanabe has received lecture fees from Mitsubishi Tanabe Pharma, Nippon Boehringer Ingelheim, and Novo Nordisc Pharma. Hisamitsu Ishihara has served on the advisory board of Astellas Pharma Inc., has received lecture fees from Astellas Pharma, MSD, Nippon Boehringer Ingelheim, and Novo Nordisc Pharma, and has received grants from Nippon Boehringer Ingelheim, Mitsubishi Tanabe Pharma, Eli Lilly, and Daiichi-Sankyo. Susumu Yamaguchia and Yoshinori Kosakai are employees of Astellas Pharma Inc. Tetsuya Ioji has no conflicts of interest that are directly relevant to the content of this article.

: The study was approved by Council for International Organizations of Medical Sciences International Ethical Guidelines and conducted in accordance with the Declaration of Helsinki and International Council for Harmonisation guidelines for Good Clinical Practice. The study protocol was approved by the Certified Review Board of Nihon University Itabashi Hospital on 9 April, 2019 (CRB3180013).

: All participants gave their written informed consent for participation in the study.

: Not applicable.

: The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.

: Not applicable.

: Conception and design of the work: HI, KW, SY, and YK. Study conduct and data acquisition: KW and HI. Analysis of data: TI. All authors contributed to the data interpretation, drafting, critical review, and revision of the manuscript and approved the final version for submission.