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Authors
Kiyosue, Arihiro https://orcid.org/0000-0003-3201-7846
Sato, Manaka https://orcid.org/0000-0001-7000-4769
Cai, Zhihong https://orcid.org/0000-0002-3431-197X
Fukushima, Yasushi https://orcid.org/0000-0002-6148-215X
Takai, Masahiko
Takahashi, Toshiyuki https://orcid.org/0000-0003-1627-8624
Nagashima, Hirotaka
Suo, Shintaro
Takeda, Ryohei
Shimoura, Kanako
Shingaki, Tomotaka https://orcid.org/0000-0003-1568-9763
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Funding
Funding for this research was provided by:
Eli Lilly Japan
Tanabe Pharma Corporation
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Article History
Received: 18 November 2025
Accepted: 26 May 2026
First Online: 23 June 2026
Declarations
Conflict of Interest: Arihiro Kiyosue has received fees from Eli Lilly Japan K.K., AstraZeneca K.K., and Tanabe Pharma Corporation. Zhihong Cai and Tomotaka Shingaki are employees of Eli Lilly Japan K.K. and shareholders in Eli Lilly and Company. Masahiko Takai is a board member of the Kanagawa Prefecture Medical Association. Shintaro Suo, Ryohei Takeda, and Kanako Shimoura are employees of Mebix, Inc., to whom performing the study was outsourced by Eli Lilly Japan K.K. Yasushi Fukushima, Toshiyuki Takahashi, and Hirotaka Nagashima have no competing interests to disclose. Manaka Sato is a shareholder of Eli Lilly and Company and contributed to this work as a former full-time employee of Eli Lilly Japan K.K. The opinions expressed in this work were solely her own and do not represent those of her current affiliation, Nippon Boehriger Ingelheim Co., Ltd.
Ethical Approval: This study was approved by Takahashi Clinic Ethics Committee (LNW00210); this approval covered the necessary ethics approvals for all five study sites. This study was conducted in accordance with the ethical principles described in the Declaration of Helsinki and the Ethical Guidelines for Medical and Biological Research Involving Human Subjects and Japanese laws and regulations.
