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南方医科大学声明:1.ThestudycompliedwiththedeclarationofHelsinkiandwasapprovedbythelocalresearchethicscommittee.Allsubjectsgavewritteninformedconsent.2.AllanimalexperimentationwasapprovedbytheSt.LouisVAAnimalCareCommitteeandconductedinconformitywiththeGuidingPrinciplesforResearchInvolvingAnimalsandHumanBeings.3.Thestudywascarriedoutwithinstitutionalreviewboardapproval.Informedconsentwasobtainedfrompatientstoperform…forstudypurposes.4.TheprotocolwasapprovedbytheInstitutionalReviewBoard(IRB)ofTheMountSinaiSchoolofMedicine.5.ThisstudywasconductedinaccordancewiththeUnitedStatesDepartmentofAgricultureAnimalWelfareAct,andtheUniversityofMissouriAnimalCareandUseCommittee(ACUC)approvedtheprotocol.AllanimalswerehousedandcaredforattheUniversityofMissouri-Columbiaanimalresearchfacilities.6.ThestudyprotocolsandinformedconsentswereapprovedbytheInstitutionalReviewboardsandInstitutionalBiosafetycommitteesofallparticipatinginstitutions.(TS)Thestudydesignandstudyprotocols,approvedbytheUSFoodandDrugAdministration(FDA),wereperformedinaccordancewithFDAregulationsCFRTitle21,applicableInternationalConferenceonHarmonizationguidelines,andNationalInstitutesofHealthGuidelinesforResearchInvolvingRecombinantDNAMolecules.7.Thisstudywasapprovedbyourinstitutionalethicalcommittee.8.ThestudywasapprovedbytheinstitutionalreviewboardoftheMayoFoundation,andallsubjectsgavewritteninformedconsent.Thestudywasdesignedandconductedentirelybythestudyteamwithoutindustrysupport.Randomizationscheduleswerepreparedbystudystatisticians.9.TheAnimalCareCommitteeoftheTorontoGeneralResearchInstituteapprovedallproceduresperformedonanimals.AllexperimentswereperformedaccordingtotheGuidetotheCareandUseofExperimentalAnimalsoftheCanadian南方医科大学CouncilonAnimalCare,andtheGuidefortheCareandUseofLaboratoryAnimals(NIHpublication85-23,revised1985).10.Thisstudywasperformedwithinformedconsent,HIPAAcompliance,andinstitutionalreviewboardapproval.11.Allotherstudyparticipantsgavewritteninformedconsent.Thestudywasapprovedbythelocalresearchethicscommittee.12.ThestudyprotocolsandinformedconsentswereapprovedbytheInstitutionalReviewboardsandInstitutionalBiosafetycommitteesofallparticipatinginstitutions.(TS)Thestudydesignandstudyprotocols,approvedbytheUSFoodandDrugAdministration(FDA),wereperformedinaccordancewithFDAregulationsCFRTitle21,applicableInternationalConferenceonHarmonizationguidelines,andNationalInstitutesofHealthGuidelinesforResearchInvolvingRecombinantDNAMolecules.标题:1.Statisticalanalysis2.Statisticalconsiderations3.Statisticsemployed4.Statisticsanddataanalysis5.Dataanalysis6.StatisticalMethods7.Statisticalanalysisofthedata8.Statistics样本含量估计1.Onthebasisofpreliminaryestimatesofthecorrespondingstandarddeviations,wedeterminedthat30subjectswouldberequiredineachgroupforthestudytohaveastatisticalpowerof90%todetectclinicallymeaningfuldifferencesbetweengroups.南方医科大学2.Priortothestudy,powercalculationsweremadebasedonsystolicanddiastolicbloodpressurevalues.PublishedresultsofbloodpressureinsubjectswithOSAcommonlyreportedastandarddeviationof14mmHgforsystolicand7mmHgfordiastolicbloodpressure.Withthisinformation,apowercalculationindicatedthatwewouldneed32patientspergrouptodetecta10-mmHgdifferenceinsystolicbloodpressureanda5-mmHgdifferenceindiastolicbloodpressurewithapowerof80%ata0.05significancelevel.统计描述:1.Dataarereportedasmean±SD.2.Dataareexpressedasmean±SD.3.Dataarepresentedasmean±SEMforcontinuousvariables,withnindicatingthenumberofpatients.4.Normallydistributeddatawerepresentedasmeans±standarderrorofthemean,logarithmicallytransformeddataasthegeometricmean(95%confidenceintervalforthemean),skeweddataasthemedian(interquartilerange),andcategoricaldataasthenumber(percentage).假设检验方法:1.Statisticaltestingutilizednon-parametrictestswithMann–WhitneyUtestandKruskal–Wallistestforcontinuousvariablesandχ2testandFisher’sexacttestforcategoricalvariables2.CategoricalvariableswerecomparedusingFisher’sexacttestand,forcontinuousvariables,thenon-parametricMann–Whitneytest.3.Differencesbetweengroupsin…(variables)wereassessedwithanalysisofvariance(ANOVA)followedbyBonferroniorFisherLSDposthoctests.4.…was/werenotnormallydistributedandthereforetheMann-WhitneyUtestwasused.ANOVAandttestingwereusedforotherparameters.5.Statisticalcomparisonsforpercentageswereperformedusingχ2analysisineach南方医科大学case.Comparisonsbetweenmeanswereperformedusingatwo-tailedt-test.6.Multivariableanalysisutilizedlogistic/linearregressionwithbackward/forward/stepwisevariableselection.7.ComparisonsofcontinuousvariablesweremadebymeansoftheunpairedStudent’sttest.Bonferroni’scorrectionwasappliedformultiplecomparisons.Correlationsbetweentargetedcontrastultrasoundsignalandbloodvolumeweremadebylinearregressionanalysis.8.DifferencesinT-cellresponsesbetweenpatientgroupsortimepointsweretestedbytheFisherexacttestortheWilcoxonsigned-ranktest.CorrelationsweretestedbythenonparametricSpearman'sranktest.9.Unpairedt-testsandx2testswereusedtostudytheclinicalprofileofECdonors.Two-tailedpairedt-testswereusedtocompareNAC-treatedandmatched–controluntreatedcells.Unpairedt-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