Document is current

Article History

Received: 30 June 2025

Accepted: 25 October 2025

First Online: 20 November 2025

Declarations

:

: This study which required processing of personal data for the purpose of research in the field of health falls under the French Data Protection Act, as described in The French Data Protection Agency (Commission Nationale de l’Informatique et des Libertés – CNIL) opinion n°2018 − 257 of 7 June 2018 on regulatory requirements and governance for processing PMSI data under expedited regulatory process (MR-006). This study was conducted in full compliance with relevant guidelines – including the Declaration of Helsinki, as well as the ICMJE guidelines – and French regulations. This study was conducted using anonymized data extracted from an existing database (PMSI); thus, according to French regulations and MR-006 process, there is no need for an informed consent from patients nor for an approval of an Ethic committee or an Institutional Review Board. Patients retain the right to withdraw or object by submitting an explicit request to their local insurance branch (CPAM), in accordance with article 111 of the application decree n° 2019 − 536 of 29 May 2019, under the Data Protection Act. Detailed instructions for this process are available at: https://www.health-data-hub.fr/politique-de-confidentialite. A collective information note has been added to both stève consultants and Pfizer websites for this purpose.

: No informed consent was required as per Decree no. 2021 − 848 of June 29, 2021, of French Public Health Code.

: RC: Consulting fees from Pfizer, Sanofi, MSD, GSK, Viatris, Cerballiance. Payment for honoraria from Pfizer, MSD, GSK, Sanofi. Payment for expert testimony from Pfizer, MSD. Travel grants from Pfizer, MSD, Sanofi, GSK. Participation to Data Safety Monitoring Board or Advisory Board for Pfizer, Sanofi, MSD, GSK MN: Consulting fees from Pfizer, research funding from Sanofi. AR: personal fees from Pfizer and from MSD outside the submitted work and nonfinancial support from Pfizer and AstraZeneca. LC, CK, FB: employees of stève consultants, under research contract with Pfizer WG, YF, SF, EB: employees of Pfizer. CL: grants to the institution ACTIV from GSK, Sanofi, Pfizer, and Merck and personal fees and non-financial support from Pfizer and Merck outside the conduct of the study. MLC: Consulting and presentation fees from Pfizer, presentation fees and advisory board participation for Sanofi.