[1] Harvard Pilgrim Hlth Care Inst, Boston, MA USA
[2] Harvard Med Sch, Dept Populat Med, Boston, MA USA
[3] US FDA, Off Biostat, Ctr Drug Evaluat & Res, Silver Spring, MD USA
[4] US FDA, Ctr Drug Evaluat & Res, Off New Drugs, Silver Spring, MD USA
[5] Ctr Dis Control & Prevent, Atlanta, GA USA
[6] Harvard Med Sch, Harvard Pilgrim Hlth Care Inst, Dept Populat Med, Boston, MA USA
[7] US FDA, Ctr Drug Evaluat & Res, Div Biometr, Off Biostat, Silver Spring, MD USA
[8] US FDA, Ctr Drug Evaluat & Res, Off Surveillance & Epidemiol, Silver Spring, MD USA
[9] IQVIA, Durham, NC USA