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The present study is part of the Drugs Systematized Assessment in real-liFe EnviRonment (DRUGS-SAFE<sup><u>R<\/u><\/sup>) research program. This program aims at providing an integrated system allowing the concomitant monitoring of drug use and safety in France. The potential impact of drugs, frailty of populations and seriousness of risks drive the research program. The French Medicines Agency played no role in the study design, conduct, and interpretation of results or discussion. This publication represents the views of the authors and does not necessarily represent the opinion of the French Medicines Agency.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"The authors declare they have no conflict of interest.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"By agreement of the French Data Protection Supervisory Authority, neither ethics committee approval nor informed consent were required for this observational study based on medico-administrative databases because of the anonymous nature of the data.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"No additional data available by author (French law to access SNDS ). The SAS code used is available from the corresponding author, antoine.pariente@u-bordeaux.fr, upon request.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material\/code availability"}},{"value":"Conception or design of the work: SMR, AJM, MT, BB, AP; data acquisition and analysis: AJM; data interpretation: SMR, AJM, MT, BB, AP; manuscript drafting: SMR, AJM, AP; manuscript critical reviewing: SMR, AJM, MT, BB, AP; final approval of the version to be published: SMR, AJM, MT, BB, AP; administrative, technical, or material support: SMR, AJM; study supervision: AP. All the authors have read and approved the final submitted manuscript, and agree to be accountable for the work.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors\u2019 contributions"}}]}}