Westhovens, R. http://orcid.org/0000-0002-3432-3073
Connolly, S. E. http://orcid.org/0000-0003-4884-861X
Margaux, J. http://orcid.org/0000-0002-9127-0203
Vanden Berghe, M. http://orcid.org/0000-0002-6739-3991
Maertens, M. http://orcid.org/0000-0002-1770-6259
Van den Berghe, M. http://orcid.org/0000-0002-4000-0385
Elbez, Y. http://orcid.org/0000-0002-1883-8632
Chartier, M. http://orcid.org/0000-0003-2469-920X
Baeke, F. http://orcid.org/0000-0002-0761-9338
Robert, S. http://orcid.org/0000-0002-2844-4346
Malaise, M. http://orcid.org/0000-0002-0132-2867
Funding for this research was provided by:
Bristol-Myers Squibb
Article History
Received: 20 February 2020
Accepted: 31 May 2020
First Online: 17 June 2020
Compliance with ethical standards
:
: R Westhovens was involved in Advisory Boards for Celltrion, Galapagos-Gilead. SE Connolly, M Chartier, S Robert and F Baeke are employees of, and hold stock in, Bristol-Myers Squibb. Y Elbez was employee of a CRO company (Excelya) contracting with Bristol-Myers Squibb. J Margaux, M Vanden Berghe, M Maertens, M Van Den Berghe and M Malaise have nothing to declare.
: The global study was conducted in accordance with the Declaration of Helsinki, International Conference on Harmonization's Guideline for Good Clinical Practice and Good Epidemiological Practice, and with the approval of the Central Ethics Committee (Ethik-Kommission der Bayerischen Landesärztekammer; IM101151) on November 1, 2008. The Belgian part of the study has been approved by a Central Ethics Committee (Commissie Medische Ethiek of the Universitaire Ziekenhuizen K.U.Leuven) on October 4, 2010.
: All patients provided written informed consent.