Funding for this research was provided by:
DEG group ltd
Received: 31 January 2018
Accepted: 23 May 2018
First Online: 6 August 2018
Ethics approval and consent to participate
: Ethics approval to conduct the trial has been granted by the Medical Ethics Review Board of the Academic Medical Center (AMC) (reference number NL54372.018.15). Trial registration: NTR 5564, date of registration: 2 November 2015. Informed consent to participate in the trial will be obtained from all participants, as outlined above.
: The study results are the property of the VU medical Center and the AMC and will be published in a peer-reviewed journal. Consent to publish data will be obtained from all participants. All authors read and approved the final manuscript and gave their consent for publishing this statistical analysis plan.
: The authors declare that they have no competing interests.
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