1. Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring; MD; U.S.A.
2. Division of Biometrics I, Office of Biostatistics, OTS, CDER; US Food and Drug Administration; Silver Spring; MD; U.S.A.
3. Office of Translational Sciences, Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring; MD; U.S.A.