1. Department of Pediatrics, Division of Pediatric Infectious Diseases and Immunology, University of Minnesota Medical School, Center for Infectious Diseases and Microbiology Translational Research, 2001 6th Street SE, Minneapolis, MN 55455, USA
2. Food and Drug Administration, Regulatory Review Office, Rockville, MD 20852, USA
3. Texas A & M Health Sciences Center, Microbial and Molecular Pathogenesis, College Station, TX 77843, USA
4. Biostatistical Design and Analysis Center, Clinical and Translational Science Institute, University of Minnesota, 717 Delaware Street SE, Minneapolis, MN 55455, USA