Updates are available Correction dated 2020-03-03

Article History

Received: 8 February 2018

Accepted: 5 July 2018

First Online: 24 July 2018

Change Date: 3 March 2020

Change Type: Correction

Change Details: Following publication of the original article [1], the authors reported an error in the “Samples size calculation and statistical considerations” section.

Ethics approval and consent to participate

: The study protocol was approved by the Institutional Review Board, the Nord Ouest IV ethics committee on the 26th of May 2016 and the Agence Nationale de sécurité des médicaments et des produits de santé (ANSM) on the 19th of July 2016 under the number 2015–001851-65. The institutional promoter is the University Hospital of Rouen, France. The trial has been registered on the ExternalRef removed website under the identification number NCT02959879, on November 9, 2016. The study complies with the Declaration of Helsinki rules and the principles of Good Clinical Practice guidelines. Informed consent will be obtained from each patient in written form prior to randomization and an information leaflet will be given to each patient prior to inclusion in the study. Patient safety and all potential threats to patient safety will be monitored by an independent monitoring board which will be able, taking into account undesirable events and the level of post-operative mortality, recommend the discontinuation of one of the treatments evaluated.

: Not applicable

: None of the authors have any competing interests.

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