title: Rejoinder.
authors.affiliation: 1 Department of Biostatistics, University of Washington, Seattle, WA, USA.
authors.forename: Thomas R
authors.initials: TR
authors.lastname: Fleming
authors.affiliation: 2 University of Wisconsin, Madison, WI, USA.
authors.forename: David L
authors.initials: DL
authors.lastname: DeMets
authors.affiliation: 3 Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Matthew T
authors.initials: MT
authors.lastname: Roe
authors.affiliation: 4 Statistics Collaborative, Inc., Washington, DC, USA.
authors.forename: Janet
authors.initials: J
authors.lastname: Wittes
authors.affiliation: 5 Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA), Silver Spring, MD, USA.|6 National Institute of Child Health and Human Development, National Institutes of Health (NIH), Bethesda, MD, USA.
authors.forename: Karim A
authors.initials: KA
authors.lastname: Calis
authors.affiliation: 3 Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Amit N
authors.initials: AN
authors.lastname: Vora
authors.affiliation: 7 University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Alan
authors.initials: A
authors.lastname: Meisel
authors.affiliation: 8 Merck Research Laboratories, North Wales, PA, USA.
authors.forename: Raymond P
authors.initials: RP
authors.lastname: Bain
authors.affiliation: 9 Tufts Medical Center, Boston, MA, USA.
authors.forename: Marvin A
authors.initials: MA
authors.lastname: Konstam
authors.affiliation: 3 Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Pencina
authors.affiliation: 10 National Heart, Lung and Blood Institute, National Institutes of Health (NIH), Bethesda, MD, USA.
authors.forename: David J
authors.initials: DJ
authors.lastname: Gordon
authors.affiliation: 11 Stanford University School of Medicine, Stanford, CA, USA.
authors.forename: Kenneth W
authors.initials: KW
authors.lastname: Mahaffey
authors.affiliation: 12 Florida Atlantic University, Boca Raton, FL, USA.
authors.forename: Charles H
authors.initials: CH
authors.lastname: Hennekens
authors.affiliation: 13 University of Minnesota, Minneapolis, MN, USA.
authors.forename: James D
authors.initials: JD
authors.lastname: Neaton
authors.affiliation: 10 National Heart, Lung and Blood Institute, National Institutes of Health (NIH), Bethesda, MD, USA.
authors.forename: Gail D
authors.initials: GD
authors.lastname: Pearson
authors.affiliation: 14 AstraZeneca, Mölndal, Sweden.
authors.forename: Tomas Lg
authors.initials: TL
authors.lastname: Andersson
authors.affiliation: 15 Brigham and Women's Hospital, Boston, MA, USA.
authors.forename: Marc A
authors.initials: MA
authors.lastname: Pfeffer
authors.affiliation: 16 University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Susan S
authors.initials: SS
authors.lastname: Ellenberg
mesh_terms: D026683:Advisory Committees; D026661:Clinical Trials Data Monitoring Committees; D012107:Research Design