Bæk, Ole
Rasmussen, Martin Bo
Gerts, Therese
Aunsholt, Lise
Zachariassen, Gitte
Sangild, Per
Nguyen, Duc Ninh http://orcid.org/0000-0002-4997-555X
Article History
Received: 1 April 2023
Revised: 10 July 2023
Accepted: 14 August 2023
First Online: 30 August 2023
Competing interests
: Oak Hill Bio currently holds the patent for recombinant human (rh)IGF-1/rhIGFBP-3 complex. University of Copenhagen have used data from this manuscript to file 2 patent applications for the use of IGF-1 to modulate immunity and neurological outcomes in newborns. O.B., P.T.S., and D.N.N. are listed as inventors in these two applications. Takada Pharmaceuticals and Oak Hill Bio were not involved in any parts of the manuscript related to the <i>FortiColos</i> trial. The companies reviewed the manuscript for comments but did not have final editorial rights over the text.
: <i>FortiColos</i> was a randomized controlled trial approved by the Danish National Committee on Health Research Ethics, registered on clinicaltrials.gov (NCT03537365) while the protocol and main results have been published elsewhere 39,4239,42. The animal experiment was conducted under a license from the Danish National Committee on Animal Experimentation (License nr. 2014-15-0201-00418).
: Parents or guardians of all participants in <i>FortiColos</i> signed informed consent forms. Data collected up until eventual withdrawal of consent was included only if allowed by the parent or guardian.