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Authors
Taniguchi, Hiroya https://orcid.org/0000-0003-1407-6682
Nishikawa, Kiyohiro https://orcid.org/0000-0003-2350-6189
Haneji, Tatsuo https://orcid.org/0009-0005-7545-8838
Izawa, Naoki https://orcid.org/0000-0003-3653-5325
Imamura, Hiroshi https://orcid.org/0000-0002-4294-6289
Yamaguchi, Hironori https://orcid.org/0000-0002-8371-9410
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Funding
Funding for this research was provided by:
Nippon Kayaku
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Article History
Received: 18 February 2025
Accepted: 9 April 2025
First Online: 8 May 2025
Declarations
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: Hiroya Taniguchi has received research grants from Daiichi Sankyo paid to the organization and personal fees from Eli Lilly Japan, Nippon Kayaku, Ono Pharmaceutical, and Takeda Pharmaceutical as honoraria or consulting fee. Kiyohiro Nishikawa was an employee of Nippon Kayaku at the time of the study and is currently with Asajes Ventures. Tatsuo Haneji is an employee of Nippon Kayaku. Naoki Izawa has received research funding from Taiho Pharmaceutical and consulting fee from Nippon Kayaku. Hiroshi Imamura has received consulting fee from Nippon Kayaku. Hironori Yamaguchi has received personal fees from Bristol Myers Squibb, Eli Lilly Japan, Nippon Kayaku, Ono Pharmaceutical, and Taiho Pharmaceutical as honoraria or consulting fee.
: The protocol of the PMS was submitted to and approved by the MHLW. The study protocol and ethical considerations of the PMS were also reviewed and approved by the internal review board of Nippon Kayaku (approval no. TRA21-20170224) and by independent ethics committees of each participating institution (Supplementary Table ). This study was conducted in accordance with the ethical principles of the Declaration of Helsinki of 1964 and its later amendments. The PMS was conducted in accordance with the Good Post-marketing Study Practice Ordinance of the MHLW, and informed consent from individual patients was not required.
