[1] US FDA, OSE, Ctr Drug Evaluat & Res, Silver Spring, MD USA
[2] Med & Healthcare Prod Regulatory Agcy, Vigilance Risk Management Med, London, England
[3] Utrecht Inst Pharmaceut Sci, Div Pharmacoepidemiol & Clin Pharmacol, Utrecht, Netherlands
[4] Korea Inst Drug Safety & Risk Management, Seoul, South Korea
[5] Harvard Univ, Sch Med, Div Pharmacoepidemiol & Pharmacoecon, Boston, MA USA