Document is current

Article History

Received: 2 March 2018

Accepted: 2 July 2018

First Online: 21 July 2018

Compliance with ethical standards

:

: Adrien Nivoliez, Caroline Dausset, Claudia Thoral, and Stéphane Patrier have an institutional affiliation with BIOSE. Jean-Michel Cardot, Philippe Judlin, and Yann Lenglet have a consultancy contract with BIOSE, the financial and logistic support of CompriGel study.

: The protocol for CompriGel clinical trial was designed according to the recommendations of the ICH Steering Committee recommendations (ICH E6), Good Clinical Practice guidelines, the declaration of Helsinki and the French legislation. Then this study was evaluated favorably by the Ethics Committee South-East IV and approved by the Competent Authority (ANSM: Agence Nationale de Sécurité du Médicament [French National Agency for Medicines and Health Products Safety]) which granted the authorization. This clinical trial was registered under 2014-001746-21 EudraCT Number.

: In accordance with the law of 6 January 1978 modified, the woman volunteer was informed in the information leaflet and gave her written consent for the processing of her personal data implemented as part of this study and to enable analysis of the research results. Before inclusion in the study, the investigator provided the woman volunteer with all the information about the study. When the woman volunteer gives her consent, she and the investigator signed and dated the consent form.