Duffaud, Florence http://orcid.org/0000-0002-2057-3557
Blay, Jean-Yves http://orcid.org/0000-0001-7190-120X
Le Cesne, Axel
Chevreau, Christine
Boudou-Rouquette, Pascaline
Kalbacher, Elsa
Penel, Nicolas http://orcid.org/0000-0001-5243-1548
Perrin, Christophe
Laurence, Valérie
Bompas, Emmanuelle http://orcid.org/0000-0003-4414-7760
Saada-Bouzid, Esma
Delcambre, Corinne
Bertucci, François http://orcid.org/0000-0002-0157-0959
Cancel, Mathilde
Schiffler, Camille
Monard, Laure
Bouvier, Corinne
Vidal, Vincent
Gaspar, Nathalie http://orcid.org/0000-0002-1827-8903
Chabaud, Sylvie
Article History
Received: 1 November 2022
Revised: 23 July 2023
Accepted: 21 August 2023
First Online: 1 November 2023
Competing interests
: FD received travel grants from Pharmamar, and Leo Pharma, attended advisory boards for Bayer, Lilly. CC attended advisory boards for Leo Pharma, JYB receives research support and honoraria from Eisei, Eli Lilly, MSD, BMS, GSK, Ignyta, Novartis, Pharmamar and Roche unrelated to this work. AL, AI, PB, EK, NP, CP, VL, EB, ESBB, FB, CS, VL, MC, CS,LM, VV, NG and SC declare no competing interests.
: The study was approved by an ethical and regulatory committee (French Ethical Committee, Comité de Protection des Personnes Sud Méditerrannée 1, approved on March 26, 2014). This study was performed in accordance wuth the Declaration of Helsinki. All patients provided written informed consent before enrolment, and one study amendment (protocol V6, June 29, 2016) expanded enrolment to include paediatric patients aged >10 years (although ultimately only one child was enrolled). The trial is registered in the European Clinical Trials Register database (EudraCT N°: 2013-003910-42) and at ClinicalTrials.gov (NCT02389244).
: Not applicable.