Author Contributions: Drs Makrides and Gibson had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Makrides, Gibson, McPhee, Yelland, Quinlivan, Ryan.
Acquisition of data: Makrides, Gibson, McPhee, Quinlivan.
Analysis and interpretation of data: Makrides, Gibson, McPhee, Yelland, Quinlivan, Ryan.
Drafting of the manuscript: Makrides, Gibson.
Critical revision of the manuscript for important intellectual content: Makrides, Gibson, McPhee, Yelland, Quinlivan, Ryan.
Statistical analysis: Makrides, Yelland, Ryan.
Obtained funding: Makrides, Gibson, McPhee, Quinlivan.
Administrative, technical, or material support: Makrides, Gibson, McPhee, Quinlivan, Ryan.
Study supervision: Makrides, Gibson, McPhee, Yelland, Quinlivan, Ryan.
Financial Disclosures: Dr Makrides reports serving on scientific advisory boards for Nestle, Fonterra, and Nutricia. Dr Gibson reports serving on scientific advisory boards for Nestle and Fonterra. Associated honoraria for Drs Makrides and Gibson are paid to their institutions to support conference travel and continuing education for postgraduate students and early career researchers. No other authors reported any financial disclosures.
Funding/Support: This work was supported by grant 349301 from the Australian National Health and Medical Research Council. Treatment and placebo capsules were donated by Efamol, England. Infrastructure support was also provided by the Women's and Children's Health Research Institute, The University of Adelaide, Women's and Children's Hospital Adelaide, Flinders Medical Centre Adelaide, Sunshine Hospital Melbourne, University of Notre Dame Australia, University of Wollongong, Campbelltown Hospital Sydney, Royal Brisbane and Women's Hospital, and University of Queensland.
Role of the Sponsor: The funding body and the company donating the capsules had no role in the study design or conduct; in the data collection, management, analysis, or interpretation; or in the preparation, review, or approval of the manuscript.
Additional Authors/Members of the DOMInO Investigative Team:Lex W. Doyle, MBBS, PhD, Peter Anderson, MPsych, PhD, Neonatal Services, Royal Women's Hospital and University of Melbourne, Australia; Paul L. Else, PhD, Barbara J. Meyer, PhD, School of Health Sciences, University of Wollongong and Campbelltown Hospital, NSW, Australia; Paul Colditz, MBBS, PhD, Margo Pritchard, RN, PhD, Perinatal Research Centre and Neonatal Unit, Royal Brisbane and Women's Hospital and University of Queensland, Australia; Shao Zhou, BND, PhD, Carmel T. Collins, RM, RN, PhD, Zoe Gulpers, BSc, MPsych, Suzanne McCusker, BSc, Nicola Naccarella, MND, Karen Best, RM, RN, Helen Loudis, BSc, Women's and Children's Health Research Institute, Adelaide SA, Australia; Amanda Anderson, PhD, Elizabeth Griffith, BA, Grad Dip Pub Health, Data Management and Analysis Centre, School of Population Health and Clinical Practice, The University of Adelaide, Adelaide, Australia.
Steering Committee: Maria Makrides, BSc, BND, PhD (chair), Robert A. Gibson, BSc, PhD (deputy chair), Andrew J. McPhee, MBBS, Lisa Yelland, BSc, Julie Quinlivan, MBBS, PhD, Philip Ryan, MBBS, BSc.
Serious Adverse Event Committee: Elinor Atkinson, MBBS, FRANZCOG (chair), Department of Obstetrics and Gynaecology, Flinders Medical Centre, Adelaide, Australia; Nick Manton, MBBS, FRCPA, Histopathology, Women's and Children's Hospital, Adelaide, Australia; Chad Andersen, MBBS, FRACP, Neonatal Medicine, Women's and Children's Hospital, Adelaide, Australia.
Additional Contributions: We thank the families who participated; the medical, nursing, and research staff in each participating center; the staff of the Child Nutrition Research Centre; and the staff of the Data Management and Analysis Centre, University of Adelaide, Adelaide, Australia.