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Authors
Watanabe, Mao https://orcid.org/0009-0005-3960-7883
Nakanishi, Michiko
Shingaki, Wataru
Gunji, Ryoji
Makinose, Yuichi
Kanno, Takashi
Ishibashi, Shun https://orcid.org/0000-0002-1063-1979
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Funding
Funding for this research was provided by:
Kowa Company, Ltd.
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Article History
Received: 18 March 2025
Accepted: 23 June 2025
First Online: 31 July 2025
Declarations
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: Mao Watanabe, Michiko Nakanishi, Wataru Shingaki, Ryoji Gunji, Yuichi Makinose, and Takashi Kanno are employees of Kowa Company, Ltd. Shun Ishibashi has received personal fees from Kowa Company, Ltd.
: This PMS study was conducted in compliance with the “Ordinance of the Ministry of Health, Labour and Welfare (No. 171 of December 20, 2004) concerning standards for post-marketing surveillance and testing of pharmaceuticals” (Ordinance on the Good Post-Marketing Study Practice) and other relevant laws and regulations in Japan. This PMS protocol was agreed to by the Japanese regulatory authority (Pharmaceuticals and Medical Devices Agency). Participating institutes were contracted by Kowa Company, Ltd. Ordinance on the Good Post-Marketing Study Practice does not specify ethical review committee deliberations or the need to obtain informed consent from patients. Therefore, deliberations by ethical review committees at participating institutes were conducted at the discretion of each site. Of all 612 participating institutes, 70 required ethical approval of the study protocol, which was granted by the relevant ethical review committee at each study site. Four of those 70 institutes also required written patient consent, which was successfully obtained.
