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Authors
Otto, Lana K. M.
Hofstra, Jacomijn
Mullen, Michelle G.
Malenczak, Derek
Boonstra, Nynke
van der Meer, Lisette
Veling, Wim
Boerhout, Cees
van Rijsbergen, Gerard D.
de Vries, Jos
van der Pol, Boudien
Pijnenborg, Gerdina H. M.
Korevaar, Lies
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Funding
Funding for this research was provided by:
Agis Innovatiefonds (2016-71)
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Article History
Received: 4 July 2019
Accepted: 28 February 2020
First Online: 27 April 2020
Ethics approval and consent to participate
: Prospective participants will receive oral and written information about the study and provide their written informed consent. All procedures are in accordance with the ethical standards of the responsible committee on human experimentation.The study will be conducted according to the principles of the Declaration of Helsinki (64th WMO General Assembly, Fortaleza, Brazil October 2013, ExternalRef removed) and in accordance with the principles of the Medical Research Involving Human Subjects Act (WMO, 2012). The study was approved by the Medical Ethical Committee of the University Medical Center Groningen, no. 2017/308. All amendments will be notified to the METC that gave a favorable opinion.A summary of the progress of the trial to the accredited METC once a year. Information will be provided on the date of inclusion of the first subject, numbers of subjects included, and numbers of subjects that have completed the trial, serious adverse events/ serious adverse reactions, other problems, and amendments.
: Not applicable.
: The authors declare that they have no competing interests.
