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Article History

Received: 2 October 2019

Accepted: 16 October 2019

First Online: 6 November 2019

Ethics approval and consent to participate

: The research proposal was reviewed by the Medical Ethics Committee of the Erasmus Medical Center, Rotterdam. Based on their review, the Committee concluded that the rules laid down in the Dutch Medical Research Involving Human Subjects Act (also known by the Dutch abbreviation WMO, in full ‘Wet Medisch-wetenschappelijk Onderzoek met mensen’) do not apply to this research proposal (proposal number MEC-2017-432), and gave permission to conduct this study at Erasmus Medical Center and to submit the results for publication in a scientific journal in the future (Letter NL/sl/321518; 24/07/2017). All participants in this study will provide informed written consent. This study has been entered into the Netherlands National Trial Register (NTR;ExternalRef removed) under catalogue number NTR7607 on 5 November 2018; updated 7th May 2019. Any important protocol modifications will be reported by the researchers to the funding body and the trial registry.

: Not applicable.

: The authors declare no conflict of interest. ZonMw has no role in any part of the research, writing and reviewing of the manuscript.