Lugtenberg, R. T.
Boers-Doets, C. B.
Witteveen, P. O.
van Herpen, C. M. L.
Wymenga, A. N. M.
de Groot, J. W. B.
Hoeben, A.
del Grande, C.
van Doorn, B.
Koldenhof, J. J.
Driessen, C. M. L.
Gelderblom, H.
Funding for this research was provided by:
Merck KGaA
Article History
Received: 8 September 2020
Accepted: 26 October 2020
First Online: 4 November 2020
Compliance with ethical standards
:
: This study was sponsored by Merck B.V., Schiphol-Rijk, The Netherlands, an affiliate of Merck KGaA, Darmstadt, Germany. C. del Grande and B. van Doorn are employees of Merck B.V. The other authors do not have financial relationships with Merck B.V.
: This study was conducted in accordance with the protocol, the ethical principles laid down in the Declaration of Helsinki, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use and Good Clinical Practice (ICH GCP), guidelines and applicable regulatory requirements. The protocol, ICF, any other materials provided to the patients and further requested information were submitted to the IEC/IRB and the competent authority. The regulatory application or submission for regulatory approval was made by the sponsor or designee as required by national law. The competent authority and the IEC/IRB were notified of the end of the study in accordance with local regulations.
: Informed consent was obtained from all individual participants included in the study.
: All authors read and approved the final manuscript.