Ethics approval and consent to participate
The study is conducted according to the principles of the Declaration of Helsinki (version 64th, October 2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO) and other guidelines, regulations and acts. The present study is approved by the Medical Research Ethics Committee East Netherlands (MREC Oost-Nederland) (number 2017–3732). The study was registered on the “Nationaal Trial Register (NTR)” with the number NTR7024. This registry was obtained from the International Clinical Trial Registry Platform (ICTRP) and can be accessed on the ICTRP Search Portal (