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1、ADVANCESINCLINICALTRIALBIOSTATISTICSeditedbyNANCYL.GELLERNationalHeart,Lung,andBloodInstituteNationalInstitutesofHealthBethesda,Maryland,U.S.A.Copyrightn2004byMarcelDekker,Inc.AllRightsReserved.MARCELMARCELDEKKER,INC.NEWYORK-BASELDEKKERThisbookwaseditedbyNanc
2、yL.Gellerinherprivatecapacity.TheviewsexpresseddonotnecessarilyrepresenttheviewsofNIH,DHHS,ortheUnitedStates.Althoughgreatcarehasbeentakentoprovideaccurateandcurrentinformation,neithertheauthor(s)northepublisher,noranyoneelseassociatedwiththispublication,shal
3、lbeliableforanyloss,damage,orliabilitydirectlyorindirectlycausedorallegedtobecausedbythisbook.Thematerialcontainedhereinisnotintendedtoprovidespecificadviceorrecommendationsforanyspecificsituation.Trademarknotice:Productorcorporatenamesmaybetrademarksorregister
4、edtrademarksandareusedonlyforidentificationandexplanationwithoutintenttoinfringe.LibraryofCongressCataloging-in-PublicationDataAcatalogrecordforthisbookisavailablefromtheLibraryofCongress.ISBN:0-8247-9032-4Thisbookisprintedonacid-freepaper.HeadquartersMarcelDe
5、kker,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
6、,Postfach812,CH-4001Basel,Switzerlandtel:41-61-260-6300;fax:41-61-260-6333WorldWideWebhttp://www.dekker.comThepublisheroffersdiscountsonthisbookwhenorderedinbulkquantities.Formoreinformation,writetoSpecialSales/ProfessionalMarketingattheheadquartersaddressabov
7、e.Copyrightnnn2004byMarcelDekker,Inc.AllRightsReserved.Neitherthisbooknoranypartmaybereproducedortransmittedinanyformorbyanymeans,electronicormechanical,includingphotocopying,microfilming,andrecording,orbyanyinformationstorageandretrievalsystem,withoutpermissi
8、oninwritingfromthepublisher.Currentprinting(lastdigit):10987654321PRINTEDINTHEUNITEDSTATESOFAMERICACopyrightn2004byMarcelDekker,Inc.AllRightsReserved.Biostatistics:ASeriesofReferencesandT