Funding for this research was provided by:
Merck Sharp and Dohme (#55890)
Received: 17 November 2019
Accepted: 10 June 2020
First Online: 17 June 2020
Ethics approval and consent to participate
: Central ethical approval was obtained from the “Commissie Mensgebonden Onderzoek” (CMO) region Arnhem-Nijmegen, an accredited Medical Research Ethics Committee in the Netherlands (file number 2018-4241). As this is a study with medicinal products, the Competent Authority—in this case the Central Committee on Research Involving Human Subjects (CCMO)—performed an additional marginal review and issued a “no grounds for non-acceptance” statement. Local ethical approval from the board of directors was obtained from each participating center before initiating recruitment. Informed consent will be obtained from all study participants.
: Not applicable.
: All authors have competing interests, as the study is funded by a grant received from Merck Sharpe & Dohme (see funding). Opinions expressed in the protocol and final article are those of the authors and not necessarily those of Merck Sharpe & Dohme.