Received: 8 November 2017
Accepted: 24 November 2018
First Online: 7 January 2019
: Dr. Kristine Amlund Hagen assumed the position of PI of the current study on 1 November 2016. The preparation of and carrying out of the study had been going on for about 1.5 years prior to her taking over as PI.
: Before the start of the research project, the trial was reviewed and approved by the Regional Committees for Medical and Health Research Ethics, Southern and Eastern Norway (REK South East), project number 2015/633. If the family agrees in an initial phone call to participate in the study, a consent letter, along with a brief description of the study is sent to the family. The NCCBD then registers receipt of a signed consent from the family. Consent from both parents is necessary if the parents have joint custody. The consent form of this study is written in Norwegian only, but it can be made available (in a translated version) upon request. It is not attached at the present.
: Not applicable.
: Author John Weisz receives royalties for sales of the MATCH protocol, of which he is a co-author. The US MATCH consultants (SKB and AMU) receive fees for their consultations on MATCH cases. Remaining authors have no financial interests in this trial. The PI and the rest of the research team are employed by the same organization as the co-consultants (the sponsor, the NCCBD). The NCCBD also works with the developer of MATCH in this study. In our analyses of the data and in any publication resulting from this study, we will be conscious of this fact and consequently analyze and present data objectively. All data and participant information are, as previously described, kept for 5 years after project termination in order to make possible audits by the Norwegian Board of Health Supervision.
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