Ethics approval and consent to participate
The study will be conducted according to the principles of the Declaration of Helsinki (version 2013, Fortaleza) and in accordance with the Medical Research Involving Human Subjects Act (WMO). The research protocol was approved by the Institutional Review Board (IRB) of the UMC Utrecht Medical Research Ethics Committee (MREC) Utrecht (NL76872.041.21, version 3, August 2021). Amendments are changes made to the research after a favorable opinion by the accredited MREC has been given. All amendments will be notified to the MERC that gave a favorable opinion. Written informed consent will be obtained from all participants.