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The information provided in this article does not represent the opinion of the French National Agency for the Safety of Medicines and Health Products (ANSM).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of Interest"}},{"value":"The study was conducted in accordance with the principles of the Declaration of Helsinki. Ethical approval was not required because the analysis was based on data from the French National Pharmacovigilance Database, which contains anonymised spontaneous reports collected within the French pharmacovigilance system (coordinated by the French National Agency for the Safety of Medicines and Health Products [\n                      Agence Nationale de S\u00e9curit\u00e9 du M\u00e9dicament et des Produits de Sant\u00e9\n                      ]).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics Approval"}},{"value":"Not applicable. Patient consent was not required since the study used anonymised secondary data that could not be used to identify individuals.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to Participate"}},{"value":"Not applicable. The study did not include any identifiable individual data.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for Publication"}},{"value":"Data sharing is not applicable to this study because the datasets used were derived from the French National Pharmacovigilance Database. These anonymised datasets are protected by confidentiality agreements and the regulations of the French Data Protection Commission (\n                      Commission Nationale de l\u2019Informatique et des Libert\u00e9s\n                      ) and cannot be made publicly available.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Data Availability"}},{"value":"The code will be made available upon reasonable request to the corresponding author.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code Availability"}},{"value":"PEP, SML and SL contributed to the conception\/design of the work; the acquisition, analysis and interpretation of the data; drafting the work and revising it critically for important intellectual content. JM, VG, PS, and SP critically revised the manuscript for important intellectual content. All authors (PEP, SML, SL, JM, VG, PS, and SP) read and approved the final version of the manuscript.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author Contributions"}}]}}