Ethics approval and consent to participate
This study was approved by the Medical Ethics Committee of Maastricht University (MU), Maastricht, the Netherlands, and performed in full accordance with the Declaration of Helsinki (latest amendment by the World Medic Association in Fortaleza, Brazil, in 2013) and Dutch Regulations on Medical Research involving Human Subjects (WMO, 1998), as well as with the International Conference on Harmonisation–Good Clinical Practice (ICH-GCP) guidelines. The study was performed at MU from October 27th, 2016 (screening visit, first subject) until October 27th, 2017 (last visit last subject). This study was registered in the US National Library of Medicine (