Gridelli, Cesare
,
Ciuleanu, Tudor
Domine, Manuel
Szczesna, Aleksandra
Bover, Isabel
Cobo, Manuel
Kentepozidis, Nikolaos
Zarogoulidis, Konstantinos
Kalofonos, Charalabos
Kazarnowisz, Andrzej
Korozan, Magdalena
de las Penas, Ramon
Majem, Margarita
Chella, Antonio
Griesinger, Frank
Bournakis, Evangelos
Sadjadian, Parvis
Kotsakis, Athanasios
Chinet, Thierry
Syrigos, Kostantinos N.
Correale, Pierpaolo
Gallou, Catherine
Jamet, Jeanne- Menez
Vetsika, Eleni- Kyriaki
Kosmatopoulos, Kostas
Georgoulias, Vassilis
Article History
Received: 13 August 2019
Revised: 13 February 2020
Accepted: 24 February 2020
First Online: 25 March 2020
Ethics approval and consent to participate
: The protocol was approved by the institutional review boards and independent ethics committees of the participating centres [Supplementary Table InternalRef removed] and registered under the NCT01935154 identifier at the <i>clinicaltrials.gov</i> website. The study was performed in accordance with the Declaration of Helsinki and was conducted in compliance with the International Conference on Harmonization on Good Clinical Practice and written informed consent was required from all patients prior to enrolment. The study was sponsored and the investigational drug was provided free of charge by Vaxon-Biotech.
: All data are available via the corresponding author and the NCT trial centre.
: C.G. has received personal fees from MSD, BMS, Astra Zeneca, Roche, Vaxon for advisory board meeting or talk at conferences during the conduct of the study. M.D. has received personal fees from Abbvie, Astra-Zeneca, BMS, Boehringer Ingelheim, Celgene, MSD, Pfizer, Roche, outside of the submitted work. M.M. has received personal fees from Roche, BMS, MSD, Astra Zeneca, Boehringer ingelheim, Lilly, Tesaro, Pfizer for travel grants outside of the submitted work. A.K. has received personal fees from Roche, BMS, MSD, Astra Zeneca, IPSEN, Amgen outside of the submitted work. V.G. reports personal fees from Sanofi for travel grants, outside the submitted work. K.K. and M.J. are shareholder and employee of Vaxon Biotech. C.G. is employee of Vaxon Biotech.
: The study was sponsored and the investigational drug was provided free of charge by Vaxon-Biotech.