[1] US FDA, Silver Spring, MD USA
[2] Harvard Med Sch, Dept Populat Med, Boston, MA USA
[3] Harvard Pilgrim Hlth Care Inst, Boston, MA USA
[4] Harvard Med Sch, Boston, MA USA
[5] Harvard Pilgrim Hlth Care Inst, Dept Populat Med, Boston, MA USA
[6] US FDA, Ctr Drug Evaluat & Res, Off Surveillance & Epidemiol, Silver Spring, MD USA