[1] US FDA, Div Biostat, Ctr Devices & Radiol Hlth, Rockville, MD 20850 USA
[2] Univ Massachusetts, Dept Math & Stat, Amherst, MA 01003 USA
[3] Harvard Univ, Sch Publ Hlth, Dept Biostat, Boston, MA 02115 USA
[4] Univ New S Wales, Sch Math, Dept Stat, Sydney, NSW 2052, Australia