Acknowledgements
Special thanks to the medical teams of all the investigational centres
and the patients without whom the study could not have been
conducted. The sponsor (LFB - Les
Ulis, France) supervised all the tasks related to the study: study
design and conduct, including the supply of IMPs; the collection,
management, analysis, and interpretation of data; preparation, review,
or approval of the manuscript; and decision to submit the manuscript for
publication. Nathalie Dinouel and Eric-Olivier Jaudinot contributed
significantly to the study as the sponsor’s project manager and the
sponsor’s senior manager, respectively. The contract research
organization Euraxi Pharma (Joué-lès-Tours, France) was appointed by the
sponsor to coordinate the study.
The authors especially thank
Virginie Martin (overall project management), Frédérique Léger (data
management), Benoit Berge (statistics), Odile Capronnier (medical
writing), and the Euraxi’s monitoring team for their contribution to the
FIDEL study.