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Article History

Received: 16 February 2017

Accepted: 27 September 2018

First Online: 12 November 2018

Ethics approval and consent to participate

: This study was approved by the Comité de Protection de la Personne CPP de Paris Ile de France VII n°15–021. This Central Ethics Committee has approved the study for the various centres (Brittany, Aquitaine, Massif Central, Languedoc-Roussillon-Midi-Pyrénées).

: The GPs will sign a written consent after receiving information, both by e-mail and by post. Participating GPs will introduce the trial to patients. Patients will also receive information sheets. GP participants will discuss the trial with patients in the light of the information provided on the information sheets. Patients will then be able to have an informed discussion with their GP. Patients will sign a written consent after information has been delivered orally, as well as in writing, prior to participating in the study and completing the questionnaires.

: Not applicable.<b>Protocol amendments</b>Any modifications to the protocol which may impact on the conduct of the study, potential benefit to the patient or may affect patient safety, 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 and approved by the Comité de Protection de la Personne CPP de Paris Ile de France VII prior to implementation and notified to the health authorities in accordance with local regulations.

: The authors declare that they have no competing interests.<b>Dissemination policy—trial results</b>We will ensure that the results are widely disseminated through publication in open-access journals as well as via conference presentations.<b>Dissemination policy—reproducible research</b>De-identified data sets will be made public when publishing the trial results.

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