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Authors
Morita, Jun https://orcid.org/0000-0002-8242-0812
Fuhr, Rainard
Koernicke, Thomas
Cho, Naoki
Mencarini, Thin Thin
Fushimi, Hideki
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Funding
Funding for this research was provided by:
Meiji Seika Pharma
DongA-ST
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Article History
Received: 2 May 2025
Accepted: 18 June 2025
First Online: 28 July 2025
Declarations
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: Jun Morita, Hideki Fushimi, Naoki Cho are employees of Meiji Seika Pharma Co., Ltd., Rainard Fuhr, Thin Thin Mencarini and Thomas Koernicke have no conflicts of interest to declare.
: The study was conducted in accordance with the Declaration of Helsinki, the International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines, and the appropriate regulatory requirements in the countries in which the study was conducted. The protocol, its amendments, and informed consent documentation were reviewed and approved by the institutional review board at the site. All participants signed an institutional review board/independent ethics committee-approved informed consent form before any study-specific procedures were performed. This trial is registered with the European Union Clinical Trials Register (EudraCT 2018-004033-33; date of registration, 17 October 2018).
