[1] Indiana Univ Sch Med, Dept Med, Div Clin Pharmacol, Indianapolis, IN 46202 USA
[2] Pfizer Inc, Global Clin Pharmacol, Global Innovat Pharma, Groton, CT 06340 USA
[3] US FDA, Off Clin Pharmacol, Off Translat Sci, Ctr Drug Evaluat & Res, Silver Spring, MD USA