Puigrenier, Sébastien
Giovannelli, Jonathan
Lamblin, Nicolas
De Groote, Pascal
Fertin, Marie
Bervar, Jean-François
Lamer, Antoine
Edmé, Jean-Louis
Balquet, Marie-Hélène
Sobanski, Vincent
Launay, David
Hachulla, Éric
Sanges, Sébastien
Article History
Received: 9 June 2022
Accepted: 29 September 2022
First Online: 15 October 2022
Declarations
:
: The study complied with the recommendations of the Helsinki declaration. French legislation on noninterventional studies does not require ethics committee approval for the use of de-identified data collected during patient care. The data were de-identified and complied with the requirements of the “<i>Commission Nationale de l’Informatique et des Libertés</i>” (CNIL), the organization responsible for ensuring the ethical use of data collected for scientific purposes in France. The CNIL approved the methods used to collect and analyze data from our patient database (approval #DEC18-445).French legislation on noninterventional studies requires collecting the non-opposition of patients but does not require written consent. As such, non-opposition was obtained from each patient included in the study for the use of their de-identified medical record data.
: Not applicable.
: SS reports travel grants from Shire, Sanofi-Genzyme, SOBI and Novartis; consulting fees from Novartis. DL reports research support from Actelion, GSK, and Pfizer; Octapharma, Takeda, Biocryst, CSL Behring. NL reported personal fees from Actelion (Janssen), Akcea, Alnylam, Amicus therapeutics, Bayer, Novartis, MSD, Pfizer, Sanofi-Aventis, and travel grants from Amgen and Bristol-Myers Squibb. PDG reports fees from Novartis, Servier, Astra-Zeneca, Abbott, Vifor, Janssen, Boehringer Ingelheim, Bayer, MSD. JFB reports travel grants from Pfizer, MSD, Janssen, AstraZeneca, Novartis Pharma France, and Chiesi; and board participation fees from Novartis Pharma France. EH reports consulting fees from Actelion, Boehringer Ingelheim, GSK, Roche-Chugai, Sanofi-Genzyme; speaking fees from Actelion, GSK, Roche-Chugai; and research funding from CSL Behring, GSK, Roche-Chugai.SP, JG, MF, AL, JLE, MHB and VS did not report any conflict of interest related to this work.