Department of Biostatistics and Programming, Sanofi, Bridgewater, NJ 08807, USA, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC 27710, USA, Exploratory Clinical & Translational Research, Bristol-Myers Squibb, Princeton, NJ 08543, USA and Center for Human Health Assessment, The Hamner Institutes for Health Sciences, Durham, NC 27709, USA.|Department of Biostatistics and Programming, Sanofi, Bridgewater, NJ 08807, USA, Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC 27710, USA, Exploratory Clinical & Translational Research, Bristol-Myers Squibb, Princeton, NJ 08543, USA and Center for Human Health Assessment, The Hamner Institutes for Health Sciences, Durham, NC 27709, USA.