Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, US Food and Drug Administration, Silver Spring, Maryland, USA. Center for Drug Evaluation and Research, Office of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, Maryland, USA. Center for Drug Evaluation and Research, Office of New Drugs, US Food and Drug Administration, Silver Spring, Maryland, USA. Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, California, USA.