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Authors
Chaneliere, Marc
Buchet-Poyau, Karine
Keriel-Gascou, Maud
Rabilloud, Muriel
Colin, Cyrille
Langlois-Jacques, Carole
Touzet, Sandrine
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Article History
Received: 22 September 2023
Accepted: 11 June 2024
First Online: 6 July 2024
Declarations
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: The study protocol was registered at clinicaltrials.gov (identifier: NCT02403388) on 30 March 2015. In accordance with the Declaration of Helsinki, the French ethics committee Sud-Est 2 confirmed on 20 March 2014 that this study did not fall within the scope of the Law of 9 August 2004 given the nature of the intervention which, therefore, served as ethical approbation for the study (decision IRB 11263). The written consent of the participants was therefore not needed. The study received authorisation from the French Data Protection Commission (CNIL) on 28 October 2014 (decision DR-2014–472). The PRisM Study was performed in accordance with all relevant guidelines and regulation.
: Not applicable.
: The authors declare no competing interests.
