[1] US FDA, Rockville, MD 20857 USA
[2] Harvard Med Sch, Dept Populat Med, Boston, MA 02115 USA
[3] Harvard Pilgrim Hlth Care Inst, Boston, MA USA
[4] US FDA, Off Surveillance & Epidemiol, Ctr Drug Evaluat & Res, Rockville, MD 20857 USA
[5] Harvard Med Sch, Boston, MA 02115 USA