Funding for this research was provided by:
French Ministry of health (Protocol N°: 2016_74)
Received: 19 July 2019
Accepted: 5 May 2020
First Online: 2 June 2020
Ethics approval and consent to participate
: Central ethical approval has been confirmed from the Committee for the Protection of People on 2 November 2018 (ref. approval no. ID-RCB 2018-A01625–50) and we will not begin recruiting at other centers in the trial until local ethical approval has been obtained. The study complies with the Declaration of Helsinki and the principles of good clinical practice guidelines. Informed consent is obtained from each patient in written form prior to randomization. Patients will be informed about the objectives, the nature, the duration and the possible adverse consequences of the trial by a surgeon familiar with the study, orally and with the help of an information letter approved by the ethics committee. Patient safety and all potential threats to the patients are monitored at each consultation. A Data and Safety Monitoring Board is not necessary because the aim of the study is to compare treatments already used in practice. Sponsor representatives will regularly review data collected on the electronic case report form at each participating site and on the basis of patient files present at those sites under the conditions defined by a monitoring plan. Any information deemed to potentially affect the safety of the trial will be brought to the attention of the sponsor.
: Not applicable.
: The authors declare that they have no competing interests.