van Uum, Rick T. http://orcid.org/0000-0001-9415-4286
Venekamp, Roderick P.
Pasmans, Clémence T. B.
de Wit, G. Ardine
Sjoukes, Alies
van der Pol, Alma C.
Damoiseaux, Roger A. M. J.
Schilder, Anne G. M.
Funding for this research was provided by:
ZonMw (839110005)
Article History
Received: 16 July 2020
Accepted: 8 February 2021
First Online: 4 March 2021
Ethics approval and consent to participate
: The trial was conducted according to the principles of the Declaration of Helsinki (10th version, October 2013) [CitationRef removed] and the Dutch Conduct Code for Health Research (Gedragscode Gezondheidsonderzoek “Goed Gedrag”) [CitationRef removed]. The Medical Ethics Review Committee of the University Medical Center Utrecht, the Netherlands, reviewed the study protocol (protocol WAG/om/14/021633) and confirmed that official approval was not required: the Medical Research Involving Human Subjects Act (WMO) does not apply to our trial as participation in the study does not add to the risks inherent to the condition (AOM) and its management in Dutch primary care. The study was monitored by an independent data monitor to ensure the quality of trial execution. All patients provided full written informed consent to participate in the trial.
: None of the authors have financial and non-financial competing interests that may be relevant to the submitted work.