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Authors
Kawai, Taketo https://orcid.org/0000-0002-7279-2874
Kiyonaga, Fumiko
Uno, Satoshi
Shibata, Hirotaka
Saito, Atsushi
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Funding
Funding for this research was provided by:
Astellas Pharma
Japan Institute for Health Security
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Article History
Received: 21 April 2026
Accepted: 31 July 2026
First Online: 6 September 2026
Declarations
Conflicts of Interest: Taketo Kawai reports receiving research funding and consulting fees from Astellas Pharma, and honoraria from Astellas Pharma, Merck Biopharma, and Sanofi. Fumiko Kiyonaga, Satoshi Uno, Hirotaka Shibata, and Atsushi Saito are employees of Astellas Pharma Inc, the sponsor of this study.
Ethical Approval: The study protocol was reviewed and approved by the Medical Affairs Protocol Review Committee of Astellas Pharma Inc. This study was conducted in accordance with the protocol, International Council for Harmonisation guidelines, applicable regulations and guidelines governing clinical study conduct, and the Declaration of Helsinki 1964 and its later amendments. As the dataset was anonymized for secondary use, the requirements for ethical approval and informed consent did not apply to this study, as specified by Japan’s Ethical Guidelines for Medical and Biological Research Involving Human Subjects. Data were purchased from MDV after obtaining the necessary permissions, and authors had permission from the database owners to access and use the database for this study.
