Funding for this research was provided by:
Received: 17 October 2019
Accepted: 10 May 2020
First Online: 19 May 2020
Ethics approval and consent to participate
: This study was performed in compliance with the ethical principles arising from the Declaration of Helsinki and all current local regulations. The study protocol was approved by Independent Ethics Committee or Institutional Review Board prior to the study launch at each site. All patients gave written informed consent.
: Not applicable.
: SN and MHS (ICON plc) are paid consultants/advisors for Merck KGaA.