Guillet, Benoit
Yan, Songkai
Hooper, Becky
Drelich, Douglass
Steenkamp, Jason
Tomic, Radovan
Mancuso, Maria Elisa
Funding for this research was provided by:
CSL Behring
Article History
Received: 13 September 2023
Accepted: 17 November 2023
First Online: 9 December 2023
Declarations
:
: Benoît Guillet has been a consultant for Baxter/Baxalta/Shire/Takeda, BioMarin CSL Behring, Laboratoire Francais du Fractionnement et Des Biotechnologies, Novo Nordisk, Octapharma, Roche-Chugaï and Swedish Orphan Biovitrum. Songkai Yan, Douglass Drelich, and Radovan Tomic are employees of CSL Behring. Becky Hooper and Jason Steenkamp are employees of EVERSANA who received funding from CSL Behring for conducting the statistical analyses that informed this study. Maria Elisa Mancuso has acted as a consultant for Bayer, BioMarin, CSL Behring, Grifols, Kedrion Biopharma, Laboratoire Francais du Fractionnement et Des Biotechnologies, Novo Nordisk, Octapharma, Pfizer, Roche, Sanofi, Swedish Orphan Biovitrum, Spark Therapeutics, Takeda, and uniQure.
: This article is based on two previously published phase 3 trials (PROLONG-9FP and B-LONG), does not contain any new studies with human participants or animals performed by any of the authors, and thus did not require ethics approval. Both PROLONG-9FP and B-LONG studies were conducted in accordance with the Declaration of Helsinki and local regulations, the protocols were approved by the authorities and the institutional review board/ethics committee at each participating center, and signed informed consent was obtained from all patients. Informed consent was not required for this analysis given the deidentified nature of the PROLONG-9FP individualized patient-level data and the use of anonymized, previously published data for the B-LONG study.
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