Ahnfeldt, Agnethe M.
Hyldig, Nana
Li, Yanqi
Kappel, Susanne Soendergaard
Aunsholdt, Lise
Sangild, Per T.
Zachariassen, Gitte http://orcid.org/0000-0003-4440-2362
Funding for this research was provided by:
Innovationsfonden (6150-00004B)
Article History
Received: 27 September 2018
Accepted: 15 April 2019
First Online: 22 May 2019
Ethics approval and consent to participate
: Central ethical approval was confirmed from Regional Scientific Ethical Committee of Southern Denmark on November 28, 2017 (ref approval no. S-20130010), and we will not begin recruiting at other centres in the trial until local ethical approval has been obtained. Approval was also confirmed from the Danish Data Protection Agency on October 4, 2017 (2008-58-0035), and the trial has been registered at ClinicalTrials.gov (NCT03537365). Written informed consent will be obtained from all participants.
: Not applicable.
: University of Copenhagen has filed a patent on the use of bovine colostrum for human infants (PCT/DK2013/050184) in collaboration with the company Biofiber Damino, which will be given an option to license the patent. PTS is listed as sole inventor, but has declined any share of potential revenue arising from commercial exploitation of such a patent. PTS is not part of any clinical work in any of the neonatal units in this study (e.g. inclusion, exclusion, information, randomisation or data collection). Other authors declare that they have no competing interests.
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