title: Rejoinder to Dr. Cyrus R. Mehta.
authors.affiliation: a Division of Biometrics I, OB/OTS/CDER, FDA , Silver Spring , Maryland , USA hsienming.hung@fda.hhs.gov.
authors.forename: H M James
authors.initials: HM
authors.lastname: Hung
authors.affiliation: b Office of Biostatistics, OTS/CDER, FDA , Silver Spring , Maryland , USA.
authors.forename: Sue-Jane
authors.initials: SJ
authors.lastname: Wang
authors.affiliation: c Division of Biometrics I, OB/OTS/CDER, FDA , Silver Spring , Maryland , USA.
authors.forename: Peiling
authors.initials: P
authors.lastname: Yang
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D006801:Humans; D015233:Models, Statistical; D012107:Research Design