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Article History

Received: 25 October 2018

Accepted: 9 October 2019

First Online: 6 January 2020

Ethics approval and consent to participate

: Central ethical approval has been confirmed from the MREC of the LUMC (ref. approval number P15.089, NL.52376.058.15) and we will not begin recruiting at other centers in the trial until local ethical approval has been obtained. The study is registered at the Netherlands Trial Register (registration code NL5652) and is conducted in accordance with the principles stated in the most recent version of the Declaration of Helsinki and the International Conference Harmonization (ICH) guidelines on Good Clinical Practice. All participants in this study are informed and provide written informed consent for participation in the study and for publication of collected data. Coded participant identification codes are be used to link data to participants. The file containing the link between participant number and personal data is managed by the investigators and data manager and is locked against access by others. Collected data are stored for 15 years. Results will be published in one or more peer-reviewed research articles and at scientific conferences.

: Not applicable.

: The authors declare that they have no competing interests.