ADVANCESINCLINICALTRIALBIOSTATISTICSeditedbyNANCYL.GELLERNationalHeart,Lung,andBloodInstituteNationalInstitutesofHealthBethesda,Maryland,U.S.A.Copyrightn2004byMarcelDekker,Inc.AllRightsReserved.ThisbookwaseditedbyNancyL.Gellerinherprivatecapacity.TheviewsexpresseddonotnecessarilyrepresenttheviewsofNIH,DHHS,ortheUnitedStates.Althoughgreatcarehasbeentakentoprovideaccurateandcurrentinformation,neithertheauthor(s)northepublisher,noranyoneelseassociatedwiththispublication,shallbeliableforanyloss,damage,orliabilitydirectlyorindirectlycausedorallegedtobecausedbythisbook.Thematerialcontainedhereinisnotintendedtoprovidespecificadviceorrecommendationsforanyspecificsituation.Trademarknotice:Productorcorporatenamesmaybetrademarksorregisteredtrademarksandareusedonlyforidentificationandexplanationwithoutintenttoinfringe.LibraryofCongressCataloging-in-PublicationDataAcatalogrecordforthisbookisavailablefromtheLibraryofCongress.ISBN:0-8247-9032-4Thisbookisprintedonacid-freepaper.HeadquartersMarcelDekker,Inc.,270MadisonAvenue,NewYork,NY10016,U.S.A.tel:212-696-9000;fax:212-685-4540DistributionandCustomerServiceMarcelDekker,Inc.,CimarronRoad,Monticello,NewYork12701,U.S.A.tel:800-228-1160;fax:845-796-1772EasternHemisphereDistributionMarcelDekkerAG,Hutgasse4,Postfach812,CH-4001Basel,Switzerlandtel:41-61-260-6300;fax:41-61-260-6333WorldWideWebhttp://www.dekker.comThepublisheroffersdiscountsonthisbookwhenorderedinbulkquantities.Formoreinformation,writetoSpecialSales/ProfessionalMarketingattheheadquartersaddressabove.Copyrightnnnnnnnn2004byMarcelDekker,Inc.AllRightsReserved.Neitherthisbooknoranypartmaybereproducedortransmittedinanyformorbyanymeans,electronicormechanical,includingphotocopying,microfilming,andrecording,orbyanyinformationstorageandretrievalsystem,withoutpermissioninwritingfromthepublisher.Currentprinting(lastdigit):10987654321PRINTEDINTHEUNITEDSTATESOFAMERICACopyrightn2004byMarcelDekker,Inc.AllRightsReserved.Biostatistics:ASeriesofReferencesandTextbooksSeriesEditorShein-Chu...