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Authors
Kojima, Tomoki
Saito, Masako
Matsuda, Toshihiro
Simmons, Neal
Nagata, Masanori
Miyagawa, Mayuko
Wojtkowski, Tomasz
Guro, Sayuri
Koibuchi, Akira
Cruz, Kimberly S.
Neutel, Joel M.
Free, Almena L.
Sekino, Hisakuni
Haas, Gabriel P.
Takusagawa, Shin
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Funding
Funding for this research was provided by:
Astellas Pharma
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Article History
Received: 18 November 2025
Accepted: 17 April 2026
First Online: 25 April 2026
Declarations
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: The clinical study was conducted in accordance with the principles of the Declaration of Helsinki, Good Clinical Practice, and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines. The protocol, its amendments, informed consent forms, investigator’s brochure, and other relevant documents (e.g., advertisements) were reviewed and approved by the Institutional Review Board of the participating sites (Advarra, Inc., Columbia, MD, for sites in the USA; and Medical Corporation Houeikai, Toshima-ku, Tokyo, for the site in Japan) before the study was initiated. All participants provided written informed consent before participation in the study.
: TK, MS, TM, MN, SG, AK, MM, and ST are employees of Astellas Pharma Inc. NS is an employee of Astellas Research Institute of America, LLC. TW and GPH are employees of Astellas Pharma Global Development, Inc. KSC, JMN, ALF, and HS have no conflicts of interest to declare.
