1. 1Division of Plasma Protein Therapeutics, Hemostasis Branch, Office of Tissues and Advanced Therapies, Center for Biologics Evaluation & Research, US Food and Drug Administration (FDA), Silver Spring, MD;
2. 2Gene Therapy Center, University of North Carolina at Chapel Hill, Chapel Hill, NC;
3. 3Bioverativ, Waltham; MA;
4. 4Laboratory of Bacterial Polysaccharides, Division of Bacterial, Parasitic, and Allergenic Products, Center for Biologics Evaluation and Research, US FDA, Silver Spring, MD;
5. 5Department of Statistics, University of Connecticut, Storrs, CT; and
6. 6Center for Gene Regulation in Health and Disease, Department of Biological, Geological and Environmental Sciences, Cleveland State University, Cleveland, OH