van Doorn, M.
Popma, A.
van Amelsvoort, T.
McEnery, C.
Gleeson, J. F.
Ory, F. G.
M. W. M., Jaspers
Alvarez-Jimenez, M.
Nieman, D. H.
Funding for this research was provided by:
ZonMw (60-63600-98-319)
Article History
Received: 9 April 2021
Accepted: 7 June 2021
First Online: 23 July 2021
Declarations
:
: The trial has received ethical approval from the Medical Ethics Review Committee (MERC) at Amsterdam University Medical Centers (AMC), the Netherlands (reference: NL66345.018.18). Written informed consent will be obtained from all participants before inclusion to the study. For participants under 16 years old, written informed consent will be obtained from a parent or guardian as well. The sponsor/investigator has a liability insurance which is in accordance with article 7 of the WMO. The sponsor (also) has an insurance which is in accordance with the legal requirements in the Netherlands (Article 7 WMO). This insurance provides cover for damage to research subjects through injury or death caused by the study. The insurance applies to the damage that becomes apparent during the study or within 4 years after the end of the study.
: Not applicable.
: The authors report no conflicts of interest.