Study concept and design: Bonifacio, Ziegler, Hasford, Achenbach.
Acquisition, analysis, or interpretation of data: Bonifacio, Ziegler, Klingensmith, Schober, Bingley, Rottenkolber, Theil, Eugster, Puff, Peplow, Buettner, Lange, Hasford, Achenbach.
Drafting of the manuscript: Bonifacio, Ziegler, Achenbach.
Critical revision of the manuscript for important intellectual content: Bonifacio, Ziegler, Klingensmith, Schober, Bingley, Rottenkolber, Theil, Eugster, Puff, Peplow, Buettner, Lange, Hasford, Achenbach.
Statistical analysis: Bonifacio, Rottenkolber, Eugster, Buettner, Lange, Hasford, Achenbach
Obtained funding: Bonifacio, Ziegler, Eugster, Achenbach.
Administrative, technical, or material support: Bonifacio, Ziegler, Klingensmith, Puff, Peplow, Eugster, Achenbach.
Study supervision: Bonifacio, Hasford.
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 study was supported by grant 8-2006-1091 from the Juvenile Diabetes Research Foundation (Bonifacio), grant 01 KG 0704 from the Bundesministerium für Bildung und Forschung in Germany (Bonifacio), grant FZ-111 from the Deutsche Forschungs Gemeinschaft, and funding from the German Federal Ministry of Education and Research (BMBF) to the German Center for Diabetes Research (DZD). Insulin crystals were provided by Lilly Pharmaceuticals.
Role of the Funder/Sponsors: The funders/sponsors had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; or the preparation or review of the manuscript. Lilly Pharmaceuticals reviewed the manuscript and agreed with the decision to submit the manuscript for publication. None of the other funders or sponsors had a role in the approval of the manuscript or the decision to submit the manuscript for publication.
Members of the Pre-POINT Study Group:Germany: Ezio Bonifacio, Anke Theil, Anne Eugster, Anette-G. Ziegler, Peter Achenbach, Miriam Krasmann, Katharina Warncke, Claudia Peplow, Ramona Puff, Leonore Thümer, Fabian Theis, Karin Lange, Mirjam Eva Bassy, Jörg Hasford, Marietta Rottenkolber, Denise Kohn; United States: Georgeanna Klingensmith, Perla Rodriguez, Maria King, Leah Briggs, Jennifer Barker, Liping Yu, George Eisenbarth; Austria: Edith Schober, Birgit Rami, Maria Fritsche, Roswith Roth; United Kingdom: Polly Bingley, Claire Matthews, Alistair Williams, Nicola Farthing.
Additional Contributions: We especially thank George Eisenbarth, MD, who brought the United States into the Pre-POINT Study. He was a founding member of the Pre-POINT steering committee, strongly contributed to the Pre-POINT study design, and strongly supported antigen-specific vaccination as a way to prevent type 1 diabetes. In many ways, Pre-POINT fulfilled his ambitions. We regret that he was unable to see the outcome of the Pre-POINT study before he passed away on November 13, 2012.
We thank Denise Kühn, Dipl Hum Biol (DFG Center for Regenerative Therapies Dresden, Technische Universität Dresden), Sevina Dietz, BSc (DFG Center for Regenerative Therapies Dresden, Technische Universität Dresden), and Claudia Matzke, Biol Tech Assist (Forschergruppe Diabetes e.V.), for laboratory assistance. None of these contributors received additional compensation for their contributions.