[1] Univ Queensland, Fac Hlth Sci, Brisbane, Qld, Australia
[2] Univ Ottawa, Dept Med, Ottawa, ON, Canada
[3] Stanford Univ, Sch Med, Stanford, CA 94305 USA
[4] US FDA, Rockville, MD 20857 USA
[5] VU Univ Hosp, Dept Clin Epidemiol, Amsterdam, Netherlands