François, Bruno http://orcid.org/0000-0002-2531-1652
Wittebole, Xavier
Ferrer, Ricard
Mira, Jean-Paul
Dugernier, Thierry
Gibot, Sébastien
Derive, Marc
Olivier, Aurélie
Cuvier, Valérie
Witte, Stephan
Pickkers, Peter
Vandenhende, François
Garaud, Jean-Jacques
Sánchez, Miguel
Salcedo-Magguilli, Margarita
Laterre, Pierre-François
Funding for this research was provided by:
Inotrem SA
Article History
Received: 10 February 2020
Accepted: 11 May 2020
First Online: 28 May 2020
Compliance with ethical standards
:
: BF reports personal fees from Inotrem during the conduct of the study, and personal fees from Biomérieux, Aridis, Ashai-Kasai, Polyphor, AM-Pharma, and Ferring outside the submitted work. XW reports fees from Inotrem during the conduct of the study, and fees from AKPA and Ferring outside the submitted work. RF reports personal fees from MSD, Pfizer, Shionogi, Grifols, Toray, and BD outside the submitted work. PFL reports personal fees from Inotrem outside the submitted work. FRV reports personal fees from Inotrem during the conduct of the study. PP reports personal fees from Inotrem during the conduct of the study, and fees from AM-Pharma, EBI, and Ferring outside the submitted work. SW has acted as a consultant to Inotrem. MD and SG hold patent EP2011055519, licensed to Inotrem. MD, AO, VC, JJG, and MSM are employees of Inotrem. JPM, TD, and MS have nothing to disclose.
: This study was performed in line with the principles of the Declaration of Helsinki. Approval of the study protocol and all amendments was granted by the following Ethics Committees: France: Comité de Protection des Personnes Ile de France (initial approval 13<sup>th</sup> September 2017; 2017-04-02 MS1 RIPH 1°). The Netherlands: Radboud University Medical Centre, Commissie Mensgebonden Onderzoek Regio Arnhem-Nijmegen (initial approval 19th July 2017; 2017-3326), Belgium: Cliniques Universitaires Saint Luc, Comité d’Éthique Hospitalo-Facultaire (initial approval 27<sup>th</sup> April 2017; 2017/15MAR138) Spain: Hospital Clinico San Carlos, Comité de Ética de la Investigación con Medicamentos (initial approval 31st May 2017; 17/162-R_M).
: Written informed consent was obtained from each participant, or authorized representative in case of incapacitated patients, prior to study enrollment.