[1] US FDA, Ctr Drug Evaluat & Res, Div Pharmacovigilance, Off Surveillance & Epidemiol, Silver Spring, MD 20993 USA
[2] Univ Alabama Birmingham, Sch Hlth Profess, Dept Hlth Serv Adm, Birmingham, AL 35233 USA
[3] Univ Alabama Birmingham, Informat Inst, Birmingham, AL 35294 USA
[4] Univ Alabama Birmingham, Ctr Integrated Syst, Elect & Comp Engn, Birmingham, AL 35294 USA
[5] US FDA, 10903,New Hampshire Ave, Silver Spring, MD 20993 USA