Ethic statement
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 “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 #DEC20-211).
French legislation on noninterventional studies requires collecting the
non-opposition of patients but does not require written consent. As
such, non-opposition was confirmed from each patient included in the
study for the use of their de-identified medical record data.