Department of Bioengineering, Stanford University, Palo Alto California, United States of America.|Division of Applied Regulatory Science, US Food and Drug Administration, Silver Spring Maryland, United States of America.|Department of Bioengineering, Stanford University, Palo Alto California, United States of America.|Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring Maryland, United States of America.|Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring Maryland, United States of America.|Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring Maryland, United States of America.|Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring Maryland, United States of America.|Department of Bioengineering, Stanford University, Palo Alto California, United States of America.