Ethics approval and consent to participate
The study has been approved by the Medical Ethical Committee of the Erasmus University Medical Centre (MEC 2022 − 0257) on 10/10/2022 and has been registered at Clinicaltrials.gov (NCT05600127) on 31/10/2022. The study will be conducted according to the principles of the Declaration of Helsinki (10th version, Portaleza, 2013) and will be in accordance with the Dutch Medical Research Involving Human Subjects Act (WMO). Informed consent to participate in the study is obtained from all participants. Individual patient data will not be published.