Study concept and design: Makrides, Yelland, Smithers, Anderson, Gibson.
Acquisition, analysis, or interpretation of data: All authors.
Drafting of the manuscript: Makrides, Gould, Yelland, Gibson.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Makrides, Yelland, Smithers.
Obtained funding: Makrides, Yelland, Smithers, Anderson, Gibson.
Administrative, technical, or material support: Makrides, Gould, Gawlik, Anderson, Gibson.
Study supervision: Makrides, Gould, Smithers, Anderson, Gibson.
Conflict of Interest Disclosures: The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Makrides reported serving on scientific advisory boards for Nestle, Fonterra, and Nutricia. Dr Gibson reported serving on a scientific advisory board for Fonterra. The 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 disclosures were reported.
Funding/Support: Both the original trial and the 4-year follow-up study were funded by National Health and Medical Research Council (NHMRC) grants 349301 (original trial) and 627174 (4-year follow-up). Treatment and control capsules were donated by Efamol (Surrey, England). Funding from the NMHRC grant was paid to Women’s and Children’s Health Research Institute and Data Management and Analysis Centre staff for contributions to the DOMInO 4-year follow-up trial.
Role of the Sponsors: The NHMRC and Efamol had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: We thank Women’s and Children’s Health Research Institute (Adelaide) staff who assisted in the 4-year follow-up, particularly trial coordinator Helen Loudis, BHSc, who was compensated. We also thank the staff at the Data Management and Analysis Centre, School of Population Health, University of Adelaide. Beverly S. Muhlhausler, BSc(Hons), PhD (School of Agriculture, Food and Wine, University of Adelaide) assisted with setting up and implementing the project management system for the follow-up study and provided comment on the manuscript without compensation.
Trial Registration anzctr.org.au Identifiers: ACTRN12605000569606 and ACTRN12611001125910