Ethics approval and consent to participate
injury or death
This study protocol has been reviewed and approved by the Medical Ethical Committee of the VU University Medical Centre Amsterdam, the Netherlands (reference no. 2019/027, NL67802.029.18). The trial will be conducted according to the principles of the Declaration of Helsinki (seventh revision 2013), the Medical Research Involving Human Subjects Act (WMO) and the EU General Data Protection Regulation (GDPR). All participants signed an informed consent form to participate in the pilot study. The sponsor’s insurance policy provides coverage for damage to research subjects through injury or death caused by participation in the study. The study has been registered in the International Clinical Trial Registry Platform: NL7764.