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Authors
Yasaka, Masahiro
Shimizu, Fumihiko
Niwa, Yuki
Kiyonaga, Ayako
Terasaka, Naoki https://orcid.org/0009-0009-2767-5060
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Funding
Funding for this research was provided by:
CSL Behring
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Article History
Received: 4 June 2024
Accepted: 24 July 2024
First Online: 3 August 2024
Declarations
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: Fumihiko Shimizu, Ayako Kiyonaga, Yuki Niwa and Naoki Terasaka are full-time employees of CSL Behring. Masahiro Yasaka has received lecture, advisory, and travel fees from AstraZeneca, Bristol-Myers Squibb, Nippon Boehringer Ingelheim, Bayer, Daiichi Sankyo, and CSL Behring, as well as scholarship funds or nonrestricted grants from Nippon Boehringer Ingelheim.
: The study was carried out in compliance with the Declaration of Helsinki (1964 and its subsequent amendments). It also adhered to the principles outlined in the Japanese Good Postmarketing Study Practice (GPSP) regulations. The protocol was approved by the Pharmaceuticals and Medical Devices Agency (PMDA) and by the ethics committees. All participating patients provided comprehensive, written informed consent. All Japanese sites that administered 4F-PCC post-approval participated in the study.
