Drusch, Solene http://orcid.org/0000-0001-6758-1901
Neumann, Anke
Michelon, Hugues
Pépin, Marion
Zureik, Mahmoud
Herr, Marie
Funding for this research was provided by:
Agence Nationale de Sécurité du médicament et des produits de santé (2019S008)
Article History
Accepted: 20 November 2023
First Online: 20 December 2023
Declarations
:
: SD, AN, HM, MP, MZ, and MH have no competing interests to declare that are relevant to the content of this article.
: This work was conducted at EPI-PHARE and University of Paris-Saclay, UVSQ and supported by the French National Agency for Medicines and Health Products Safety [Grant no. 2019S008] within the scope of Ph.D. funding to S.D.
: The French National Agency for Medicines and Health Products Safety had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication.
: In accordance with data protection legislation and French regulations, the authors cannot publicly release data from the French National Health Data System (SNDS). However, any person or structure, public or private, for-profit or nonprofit, is entitled to access SNDS data upon authorization from the French Data Protection Office (CNIL), for the purposes of carrying out a study, research, or an evaluation in the public interest (ExternalRef removed and ExternalRef removed). EPI-PHARE has permanent regulatory access to data from the French National Health Data System (SNDS) via its constitutive bodies ANSM and CNAM. This permanent access is given in accordance with French Decree no. 2016-1871 of 26 December 2016 relating to personal data processing under the French National Health Data System (SNDS) and French law articles Art. R. 1461-13 and 14. All requests in the database were made by duly authorized people. In accordance with the permanent regulatory access granted to EPI-PHARE via ANSM and CNAM, this work did not require the approval of the French Data Protection Authority (CNIL). The study was registered on the study register of EPI-PHARE for studies based on SNDS data (T-2021-10-340).
: This study has been authorized and conducted according to decree 2016–1871 of 26 December 2016 relating to personal data processing under the French National Health Data System (SNDS) and French law articles Art. R. 1461–1323 and 1424(5). As permanent users of the SNDS, the author’s team is exempted from institutional review board approval. Given that data are anonymous, informed consent to participate was not required.
: This study is a part of the PhD thesis of S.D. and supervised by M.H. and M.Z. M.H. and M.Z. conceptualized the study. M.H., M.Z., H.M., M.P., and S.D. designed the methodology, S.D. and A.N. extracted and managed the data, S.D. performed the analyses under the supervision of A.N. and M.H. S.D. wrote the manuscript and M.H., H.M., A.N., M.P., and M.Z. reviewed and edited the manuscript. M.Z., S.D.