Innovative Designs and Logistical Considerations for Expedited Clinical Development of Combination Disease-Modifying Treatments for Type 1 Diabetes.

"Duality of Interest. R.L.A. was a JDRF board director at the time of ideation of the manuscript and is a consultant to Provention Bio, Inc. L.A.D. receives institutional support for research studies from Provention Bio, Inc., and MannKind Corporation; has been a consultant to Vertex Pharmaceuticals, Inc., and Merck & Co., Inc.; and is inventor on a patent application for use of α-difluoromethylornithine. C.M.D. is an advisor to Provention Bio, Inc. P.S.L. is a consultant with Bristol-Myers Squibb Company. K.C.H. has been a consultant to Provention Bio, Inc., Novo Nordisk A/S, Tiziana Life Sciences, Ltd., NexImmune, Inc., and Viela Bio, Inc./Horizons Therapeutics, plc, and is coinventor on a patent for use of anti-CD3 monoclonal antibody. M.M. is a JDRF staff member. S.T.A. was a scientific portfolio lead at JDRF at the time of ideation of the manuscript and has since moved to the nonprofit New York Stem Cell Foundation Research Institute. No other potential conflicts of interest relevant to this article were reported."