DVP/OVRR, Center for Biologics Evaluation and Research, US Food and Drug Administration, Bethesda, MD 20892, USA.|DVP/OVRR, Center for Biologics Evaluation and Research, US Food and Drug Administration, Bethesda, MD 20892, USA.|DVP/OVRR, Center for Biologics Evaluation and Research, US Food and Drug Administration, Bethesda, MD 20892, USA.|DVP/OVRR, Center for Biologics Evaluation and Research, US Food and Drug Administration, Bethesda, MD 20892, USA.|DVP/OVRR, Center for Biologics Evaluation and Research, US Food and Drug Administration, Bethesda, MD 20892, USA.