Edwards, Christopher J.
Monnet, Joƫlle
Ullmann, Martin
Vlachos, Pantelis
Chyrok, Veranika
Ghori, Vishal
Funding for this research was provided by:
Merck
Article History
Received: 21 June 2019
Revised: 21 June 2019
Accepted: 4 July 2019
First Online: 8 August 2019
Compliance with ethical standards
: Prior to commencement of the study at a given site, the Clinical Study Protocol was submitted together with its associated documents, to the responsible Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for its favorable opinion or approval. Amendments to these documents were submitted to the concerned IEC or IRB before implementation of substantial changes. Relevant safety information was submitted to the IEC or IRB during the course of the study in accordance with national regulations and requirements. All subjects provided written informed consent. The study was conducted in accordance with the current International Council for Harmonisation Good Clinical Practice and the Declaration of Helsinki, as well as with applicable local regulations. The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.
: C.J.E. has received honoraria for attendance at advisory boards for AbbVie, Biogen, BMS, Celgene, Fresenius Kabi, GSK, Janssen, Lilly, Mundipharma, Roche, and Sanofi; and as a consultant for Anthera, Merck, and Samsung Bioepis; and has received grants as an investigator for AbbVie, Biogen, and Pfizer. J.M, M.U., and V.G. are employees of Fresenius Kabi SwissBioSim. V.C. is a former employee of Fresenius Kabi SwissBioSim. P.V. has no conflicts of interest to declare.