Study concept and design: Knip, Akerblom, Becker, Dosch, Dupre, Fraser, Ilonen, Krischer, Kordonouri, Palmer, Savilahti, Vaarala, Virtanen.
Acquisition, analysis, or interpretation of data: Knip, Akerblom, Becker, Dupre, Fraser, Howard, Ilonen, Krischer, Lawson, Palmer, Vaarala, Virtanen.
Drafting of the manuscript: Knip, Becker, Dosch, Krischer, Kordonouri, Palmer.
Critical revision of the manuscript for important intellectual content: Knip, Akerblom, Becker, Dosch, Dupre, Fraser, Howard, Ilonen, Krischer, Kordonouri, Lawson, Palmer, Savilahti, Vaarala, Virtanen.
Statistical analysis: Becker, Krischer.
Obtained funding: Knip, Akerblom, Becker, Dosch, Dupre, Krischer, Lawson, Palmer.
Administrative, technical, or material support: Knip, Akerblom, Becker, Dupre, Fraser, Ilonen, Krischer, Palmer, Savilahti, Vaarala, Virtanen.
Study supervision: Akerblom, Becker, Dupre, Krischer, Palmer, Vaarala, Virtanen.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Funding/Support: This work was supported by the National Institute of Child Health and Development (NICHD), the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health (grant numbers HD040364, HD042444, and HD051997), Canadian Institutes of Health Research, the Juvenile Diabetes Research Foundation International, and the Commission of the European Communities (specific RTD program, Quality of Life and Management of Living Resources, contract number QLK1-2002-00372 Diabetes Prevention). Other funding came from the European Foundation for the Study of Diabetes/Juvenile Diabetes Research Foundation/Novo Nordisk Focused Research Grant, Academy of Finland (Centre of Excellence in Molecular Systems Immunology and Physiology Research 2012-2017, decision no 250114), Dutch Diabetes Research Foundation, and Finnish Diabetes Research Foundation. Mead Johnson Nutrition provided the blinded color-coded study formulas.
Role of the Sponsors: Mead Johnson Nutrition, as well as all funding sources, 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 Mead Johnson Nutrition for providing the study formulas free of charge and Jim W Hansen, MD, and Carol Berseth, MD, of that company for their collaboration and support. We also thank Gilman Grave, MD, project official for TRIGR (Trial to Reduce IDDM [insulin-dependent diabetes mellitus] in the Genetically at Risk) at the NICHD, for stimulating encouragement and collaboration over the years. Drs Hansen, Berseth, and Grave have not received any compensation in association with their contributions to this article. We acknowledge the dedicated and competent TRIGR staff at all clinical sites, data management unit, laboratories, research institutes, and administrative centers for their enthusiasm. We deeply thank all participating families for their commitment and look forward to their continued participation until the end of the study.