Tinland, Aurélie http://orcid.org/0000-0002-8168-930X
Leclerc, Léa
Loubière, Sandrine
Mougeot, Frederic
Greacen, Tim
Pontier, Magali
Franck, Nicolas
Lançon, Christophe
Boucekine, Mohamed
Auquier, Pascal
Funding for this research was provided by:
Direction Générale de l’offre de Soins (PREPS-17-0575)
Article History
Received: 20 November 2019
Accepted: 17 December 2019
First Online: 27 December 2019
Ethics approval and consent to participate
: The study is designed and carried out in accordance with the principles of the Declaration of Helsinki, sixth revision. A psychiatrist has to rule for each participant if he is ethically and medically capable of consenting for his participation. People under guardianship are not included in the study. The participants provide both oral and written consent Additional file InternalRef removed. The Institutional Review Board (Comité de Protection des Personnes Sud-Ouest et Outre-mer 4) approved the study protocol and the informed consent form with number 2018-A00146–49 for seven centres: ARHM and Vinatier in Lyon; APHM, Edouard Toulouse and Valvert in Marseille; GHU and Argenteuil in Paris. The trial is registered with the international standard randomised control trial number NCT03630822.Any modifications to the protocol that may impact on the conduct of the study, including changes of study objectives, study design, patient population, sample sizes, study procedures, or significant administrative aspects will require a formal amendment to the protocol. Such amendment will be agreed upon by the Steering Committee, and approved by the Institutional Review Board (CPP) prior to implementation and notified to the health authorities in accordance with local regulations.The project complies with the general regulation on data protection. It conforms to the CNIL reference methodology (French authority on computing and freedom), which ensures that research respect the confidentiality of patient data.
: Not applicable.
: The authors declare that they have no competing interests.