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, Davis, Simmer, Colditz, Morris, Smithers.
Acquisition of data: Makrides, McPhee, Collins, Doyle, Simmer, Colditz, Morris, Smithers, Ryan.
Analysis and interpretation of data: Makrides, Gibson, McPhee, Collins, Davis, Doyle, Simmer, Willson, Ryan.
Drafting of the manuscript: Makrides, Gibson.
Critical revision of the manuscript for important intellectual content: Makrides, Gibson, McPhee, Collins, Davis, Doyle, Simmer, Colditz, Morris, Smithers, Willson, Ryan.
Statistical analysis: Willson, Ryan.
Obtained funding: Makrides, Gibson, McPhee, Davis, Simmer, Morris.
Administrative, technical, or material support: Makrides, Gibson, McPhee, Collins, Davis, Doyle, Colditz, Morris, Smithers, Ryan.
Study supervision: Makrides, Gibson, McPhee, Collins, Simmer, Morris, Ryan.
Financial Disclosures: Drs Makrides, Gibson, and Simmer have in the past conducted trials of fatty acid supplementation funded by the formula industry. These authors have no financial interests in the production or sales of infant formula or nutritional supplements. Dr Makrides serves on scientific advisory boards for Nestle, Fonterra, and Nutricia; Dr Gibson serves on scientific advisory boards for Wyeth, Fonterra, and Nestle; and Dr Simmer serves on a scientific advisory board for Wyeth. 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. The honorarium for Dr Simmer is paid to her directly. No other disclosures were reported.
Serious Adverse Event Committee: J. E. Hiller, PhD, School of Population Health and Clinical Practice, University of Adelaide, Adelaide, Australia; J. Lipsett, BM, BS, PhD, FRCPA, Histopathology, Women's and Children's Hospital, Adelaide, Australia; B. M. Headley, FRACP, Neonatal Medicine, Women's and Children's Hospital, Adelaide, Australia.
Funding/Support: This study was supported by a grant from the Australian National Health and Medical Research Council (grant 250322) and by the Channel 7 Children's Research Foundation of South Australia Inc. Treatment and placebo capsules were donated by Clover Corp and infant formula was donated by Mead Johnson Nutritionals and Nutricia Australasia.
Role of the Sponsor: None of the funding bodies or companies had any role in the study design or conduct; data collection, management, analysis or interpretation; or preparation, review, or approval of the manuscript.
Additional Contributions: We thank the families who participated, the medical, nursing, and research staff in each participating center, and the staff of the Child Nutrition Research Centre and the staff of the Data Management and Analysis Centre, University of Adelaide. We acknowledge the contribution of Karen Best, RN, RM, Child Nutrition Research Centre, University of Adelaide, who was the trial coordinator, and of David Ellis, BPharm, Pharmacy, Women's and Children's Hospital, who was responsible for coordinating the quality management of study capsules. Ms Best was employed using trial grant money and Mr Ellis' department was partially compensated for his time by trial grant money.