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Authors
Wada-Hiraike, Osamu https://orcid.org/0000-0002-3458-6711
Maruyama, Aya https://orcid.org/0009-0007-8700-8679
Mitobe, Yuko https://orcid.org/0000-0001-8897-8561
Iriyama, Takayuki https://orcid.org/0000-0001-7970-6695
Mori-Uchino, Mayuyo https://orcid.org/0000-0003-4545-0569
Osuga, Yutaka https://orcid.org/0000-0002-6660-1066
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Funding
Funding for this research was provided by:
Torii Pharmaceutical
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Article History
Received: 27 October 2024
Accepted: 20 January 2025
First Online: 7 March 2025
Declarations
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: Aya Maruyama and Yuko Mitobe are employees of Torii Pharmaceutical Co., Ltd., Tokyo, Japan. Osamu Wada-Hiraike, Takayuki Iriyama, Mayuyo Mori-Uchino, and Yutaka Osuga have no potential conflicts of interest to disclose.
: The study protocol was approved by the University of Tokyo, Clinical Research Review Board (no. 2021506SP), and all patients provided written informed consent at enrollment. The study was conducted in accordance with the latest versions of the Declaration of Helsinki, the Clinical Trials Act, the Enforcement Regulation of Clinical Trials Act (Ministry of Health Labour and Welfare ordinance), and all applicable laws and regulations. The study was registered with the Japan Registry of Clinical Trials (trial ID, jRCTs031210634).
