Study design
The current study is a prospective randomized controlled double-blind
study. For conduction of the study, institutional review board approval
was obtained from the Ethical Committee of UZ Brussel (13/06/2018,
reference number 2018/163) and the local Ethical Committee of Centre
Hospitalier Universitaire Tivoli (05/04/2018, reference number 1245).
This trial has been registered with EudraCT registry, number
2017-004797-33, on the 17th of March 2018.