Lvovschi, Virginie Eve http://orcid.org/0000-0003-2903-1911
Joly, Justine
Lemaire, Nicolas
Maignan, Maxime
Canavaggio, Pauline
Leroi, Anne-Marie
Tavolacci, Marie-Pierre
Joly, Luc-Marie
Funding for this research was provided by:
PHRCN (760780239)
Article History
Received: 26 December 2018
Accepted: 25 March 2019
First Online: 11 April 2019
Ethics approval and consent to participate
: The study protocol and patient-informed consent procedures received Ethics Committee approval (SUD-MEDITERRANEE1 approval number 17 32) on 17 May 2017 prior to registration (reference number 2014/009/HP).Authorization for this protocol has also been granted by the ANSM (French Competent Authority) (art. L 1123-8 of French Public Health Code). Thanks to these two centralized procedures, this study has gained ethical approval at both central and local levels for all centers participating in the study. Any modifications to the protocol that may impact the conduct of the study, potential benefit to the patient, or that may affect patient safety will require a formal amendment to the protocol and new approval from the Ethics Committee according to local regulations and a request for authorization by the ANSM (art. L 1123-9). Approval by these two institutional committees is also required for new center recruiting.Information has been provided to the directors and pharmacists of centers participating in the study before the research began (art. L 1123-13 of French Public Health Code).
: The authors declare that they have no competing interests.However, the authors VEL and NL disclose that they have individually received occasional travel grants for participation in national and international congresses from Mundipharma.
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