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Article History

Received: 30 January 2017

Accepted: 8 May 2018

First Online: 16 May 2018

Ethics approval and consent to participate

: The study has been submitted and approved by regulatory authorities (ANSM; date of approval: 13/10/2016) and ethics committee (Centre de Protection des Personnes; date of approval: 13/10/2016). The study opened in September 2015.A written informed consent will be obtained from the study participants.There is an agreement between each participating center and the Centre Oscar Lambret. Each protocol version is signed by the principal investigator. We have a copy of each signed document.In France, according to the current law, a protocol can be subjected to any regional Ethics Committee, even if no hospital of this region takes part to the trial. The choice is made according to the workload of every committee. The opinion of this Ethics Committee applies to all the national centers.

: A part of the trial cost is financially supported by Aquilab. The study protocol has undergone peer-review by Aquilab.The authors declare that they have no competing interests.

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