Sanges, Sébastien
Germain, Nicolas
Vignes, Stéphane
Séguy, David
Stabler, Sarah
Etienne, Nicolas
Terriou, Louis
Launay, David
Hachulla, Éric
Huglo, Damien
Dubucquoi, Sylvain
Labalette, Myriam
Lefèvre, Guillaume
Article History
Received: 31 December 2021
Accepted: 27 May 2022
First Online: 23 June 2022
Change Date: 25 August 2022
Change Type: Update
Change Details: The original version of this paper was updated to present the correct corresponding author and the correct name of the first author
Change Date: 26 August 2022
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1007/s10875-022-01356-9
Declarations
:
: SS reports travel/accommodation expenses from Shire. DL reports grants and personal fees from Octapharma and CSL Behring; grants from Grifols. GL received advisory fees from Shire and Takeda, travel/accommodation expenses from Octapharma, and research grants from LFB, Takeda, Octapharma, CSL Behring. NG, SV, DS, SaS, NE, LT, DH, EH, SD, ML report no conflict of interest related to this work.
: The study complied with the recommendations of the Helsinki declaration. French legislation on non-interventional studies does not require ethics committee approval for the use of de-identified data collected during patient care. As such, the need for an ethics committee approval was waived for this study by the “Comité de Protection des Personnes” (CPP). The data were de-identified and complied with the requirements of the “Commission Nationale de l’Informatique et des Libertés” (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 #DEC20-229).
: 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 and publication of their de-identified medical record data.