2024
Needs assessment and patient-guided development of a video-based diabetic retinopathy patient education tool
Ahmed O, Applebaum S, Ahmad M, Ahmed D, Juthani P, Nwanyanwu K. Needs assessment and patient-guided development of a video-based diabetic retinopathy patient education tool. Health Education Journal 2024, 83: 587-597. DOI: 10.1177/00178969241258818.Peer-Reviewed Original ResearchPatient perspectivePatients' health knowledgePost-intervention interviewsPatient education toolsAcademic medical centreSemi-structured interviewsPatient uptakeLifestyle factorsQualitative interview dataNeeds assessmentPatient educationVideo educationHealth knowledgeRetina physiciansUnique educational needsImprove accessDiabetes managementEducational materialsEducational videosPhysiciansMedical CentreDR knowledgeDR patientsEffective communicationCohort BARC-9: A randomized study to evaluate etrumadenant based treatment combinations in previously treated metastatic colorectal cancer (mCRC).
Wainberg Z, Han S, Lee S, Lee K, Kopetz S, Mizrahi J, Hong Y, Ghiringhelli F, Italiano A, Tougeron D, Beagle B, Boakye M, Zhao T, Rhee J, Nuyten D, Cecchini M. ARC-9: A randomized study to evaluate etrumadenant based treatment combinations in previously treated metastatic colorectal cancer (mCRC). Journal Of Clinical Oncology 2024, 42: 3508-3508. DOI: 10.1200/jco.2024.42.16_suppl.3508.Peer-Reviewed Original ResearchProgression-free survivalMetastatic colorectal cancerOverall survivalCohort BActivation of effector T cellsManagement of metastatic colorectal cancerAnti-PD-1 antibodyTreat metastatic colorectal cancerTreated with 5-FURandomized phase II clinical trialIrinotecan-containing regimensPhase Ib/II trialPhase II clinical trialEffector T cellsAdenosine receptor blockadeCohort of patientsII clinical trialsIrinotecan regimensMFOLFOX-6OS improvementReceptor blockadePrimary endpointProspective trialsReceptor antagonistSecondary endpointsEffectiveness of the fourth dose of COVID-19 vaccines against severe COVID-19 among adults 40 years or older in Brazil: a population-based cohort study
Neto F, Hitchings M, Amin A, de França G, Lind M, Torres M, Tsuha D, de Oliveira R, Cummings D, Dean N, Andrews J, Ko A, Croda J, Ranzani O. Effectiveness of the fourth dose of COVID-19 vaccines against severe COVID-19 among adults 40 years or older in Brazil: a population-based cohort study. The Lancet Regional Health - Americas 2024, 34: 100755. PMID: 38737773, PMCID: PMC11087726, DOI: 10.1016/j.lana.2024.100755.Peer-Reviewed Original ResearchSevere COVID-19Cohort ACohort B.Cohort BTwo-doseMRNA vaccinesPrimary outcomeBooster dose effectivenessCOVID-19 outcomesPopulation-based cohort studyDose of COVID-19 vaccinePopulation-based cohortPopulation-based cohort of individualsCOVID-19 vaccine dosesSevere COVID-19 outcomesFollow-upCohort studyMRNA-basedVaccine doseCohort of individualsVaccine effectivenessVaccine combinationsDoseLower hazardCohortPembrolizumab Plus mFOLFOX7 or FOLFIRI for Microsatellite Stable/Mismatch Repair-Proficient Metastatic Colorectal Cancer: KEYNOTE-651 Cohorts B and D
Kim R, Tehfe M, Kavan P, Chaves J, Kortmansky J, Chen E, Lieu C, Wong L, Fakih M, Spencer K, Zhao Q, Predoiu R, Li C, Leconte P, Adelberg D, Chiorean E. Pembrolizumab Plus mFOLFOX7 or FOLFIRI for Microsatellite Stable/Mismatch Repair-Proficient Metastatic Colorectal Cancer: KEYNOTE-651 Cohorts B and D. Clinical Colorectal Cancer 2024, 23: 118-127.e6. PMID: 38762348, DOI: 10.1016/j.clcc.2024.03.001.Peer-Reviewed Original ResearchMetastatic colorectal cancerObjective response rateCohort BCohort DAdverse eventsColorectal cancerT-cell-inflamed gene expression profileInvestigator-assessed objective response ratePD-L1 combined positive scoreTreatment-related adverse eventsResponse rateCombined positive scoreDose-limiting toxicityMedian follow-upTumor mutational burdenDecreased neutrophil countPrimary end pointMismatch repair-proficientStandard of careBiomarker analysisMethods PatientsRECIST v1.1PD-L1HER2 expressionMutational burden
2023
Phase II study of trifluridine/tipiracil in metastatic breast cancers with or without prior exposure to fluoropyrimidines
Lim J, Ow S, Wong A, Lee M, Chan G, Low J, Sundar R, Choo J, Chong W, Ang Y, Tai B, Lee S. Phase II study of trifluridine/tipiracil in metastatic breast cancers with or without prior exposure to fluoropyrimidines. European Journal Of Cancer 2023, 193: 113311. PMID: 37717281, DOI: 10.1016/j.ejca.2023.113311.Peer-Reviewed Original ResearchMetastatic breast cancerObjective response rateProgression-free survivalPhase II studyCohort ABreast cancerDetermination of progression-free survivalSingle-arm phase II studyTreatment of metastatic breast cancerConsistent with known toxicitiesMedian progression-free survivalClinical benefit rateDose-confirmation phaseTreated with FTD/TPIDose modificationII studyCohort BBenefit rateFTD/TPISafety profileFluoropyrimidineGastric cancerPatientsResponse rateAntitumour activityAssociation Between Biomarkers and Clinical Outcomes of Pembrolizumab Monotherapy in Patients With Metastatic Triple-Negative Breast Cancer: KEYNOTE-086 Exploratory Analysis
Loi S, Salgado R, Schmid P, Cortes J, Cescon D, Winer E, Toppmeyer D, Rugo H, De Laurentiis M, Nanda R, Iwata H, Awada A, Tan A, Sun Y, Karantza V, Wang A, Huang L, Saadatpour A, Cristescu R, Yearley J, Lunceford J, Jelinic P, Adams S. Association Between Biomarkers and Clinical Outcomes of Pembrolizumab Monotherapy in Patients With Metastatic Triple-Negative Breast Cancer: KEYNOTE-086 Exploratory Analysis. JCO Precision Oncology 2023, 7: e2200317. PMID: 37099733, DOI: 10.1200/po.22.00317.Peer-Reviewed Original ResearchConceptsMetastatic triple-negative breast cancerTriple-negative breast cancerClinical outcomesPembrolizumab monotherapyPD-L1Metastatic diseaseGEP signaturesBreast cancerStromal tumor-infiltrating lymphocytesT-cell-inflamed gene expression profileExploratory biomarker analysisMore systemic therapiesPD-L1 CPSTumor PD-L1PD-L1 statusTumor-infiltrating lymphocytesImproved clinical outcomesTumor mutational burdenSignature 3Mutational signature 3Cohort BDifferentiation 8Systemic therapyCohort ACombined cohortComparative Safety of Biologic Agents in Patients With Inflammatory Bowel Disease With Active or Recent Malignancy: A Multi-Center Cohort Study
Holmer A, Luo J, Russ K, Park S, Yang J, Ertem F, Dueker J, Nguyen V, Hong S, Zenger C, Axelrad J, Sofia A, Petrov J, Al-Bawardy B, Fudman D, Llano E, Dailey J, Jangi S, Khakoo N, Damas O, Barnes E, Scott F, Ungaro R, Singh S, Helping-IBD R. Comparative Safety of Biologic Agents in Patients With Inflammatory Bowel Disease With Active or Recent Malignancy: A Multi-Center Cohort Study. Clinical Gastroenterology And Hepatology 2023, 21: 1598-1606.e5. PMID: 36642291, DOI: 10.1016/j.cgh.2023.01.002.Peer-Reviewed Original ResearchConceptsNon-TNF biologicsInflammatory bowel diseaseProgression-free survivalRecurrence-free survivalTNFα antagonistsActive cancerPrior cancerCohort studyBiologic agentsBowel diseaseRecent cancerMulticenter retrospective cohort studyMulti-center cohort studyIBD disease severityRetrospective cohort studyChoice of biologicsTumor necrosis factorCohort BPrimary outcomeComparable safetyΑ antagonistsComparative safetyCancer recurrenceNecrosis factorPatients
2022
Pembrolizumab (pembro) plus mFOLFOX7 or FOLFIRI for metastatic colorectal cancer (CRC) in KEYNOTE-651: Long-term follow-up of cohorts B and D.
Kim R, Tehfe M, Kavan P, Chaves J, Kortmansky J, Chen E, Lieu C, Wong L, Fakih M, Spencer K, Zhao Q, Predoiu R, Li C, Carpenter D, Leconte P, Chiorean E. Pembrolizumab (pembro) plus mFOLFOX7 or FOLFIRI for metastatic colorectal cancer (CRC) in KEYNOTE-651: Long-term follow-up of cohorts B and D. Journal Of Clinical Oncology 2022, 40: 3521-3521. DOI: 10.1200/jco.2022.40.16_suppl.3521.Peer-Reviewed Original ResearchCohort BColorectal cancerCohort DPMMR colorectal cancerRECIST v1.1End pointExploratory end pointsPD-L1 dataSingle-arm cohortAntitumor activityManageable safety profileMetastatic colorectal cancerPrimary end pointSecondary end pointsNew safety signalsAntitumor immune responseCombination of chemotherapyKRAS mutation statusGreater antitumor activityData cutoffStarting doseNeutrophil countPrior linesInvestigator reviewSafety profile
2021
SYST-06. PHASE II TRIAL OF PAXALISIB (GDC-0084) IN COMBINATION WITH TRASTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER BRAIN METASTASES (BCBM)
Leone J, Tayob N, Pereslete A, Ligibel J, Parsons H, Bi W, Zhao J, Winer E, Lin N. SYST-06. PHASE II TRIAL OF PAXALISIB (GDC-0084) IN COMBINATION WITH TRASTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER BRAIN METASTASES (BCBM). Neuro-Oncology Advances 2021, 3: iv9-iv9. DOI: 10.1093/noajnl/vdab112.034.Peer-Reviewed Original ResearchBreast cancer brain metastasesObjective response rateCohort BCohort ACNS metastasesPrimary endpointHER2-positive breast cancer brain metastasesNeuro-Oncology Brain Metastases criteriaCentral nervous system metastasesHER2-positive breast cancerPatient-derived xenografts (PDX) modelsPhase II cohortNervous system metastasesPhase II studyCancer brain metastasesPhase II trialPI3K/Akt/mTORPatient-reported outcomesPI3KBrain-penetrant inhibitorAkt/mTORMetastasis (TNM) criteriaBrain metastasesII trialMetastasis resectionA phase II study of efficacy, toxicity, and the potential impact of genomic alterations on response to eribulin mesylate in combination with trastuzumab and pertuzumab in women with human epidermal growth factor receptor 2 (HER2)+ metastatic breast cancer
Balch SM, Vaz-Luis I, Li T, Tayob N, Jain E, Helvie K, Buendia-Buendia JE, Shannon E, Isakoff SJ, Tung NM, Krop IE, Lin NU, Wagle N, Freedman RA. A phase II study of efficacy, toxicity, and the potential impact of genomic alterations on response to eribulin mesylate in combination with trastuzumab and pertuzumab in women with human epidermal growth factor receptor 2 (HER2)+ metastatic breast cancer. Breast Cancer Research And Treatment 2021, 189: 411-423. PMID: 34302589, DOI: 10.1007/s10549-021-06329-x.Peer-Reviewed Original ResearchConceptsHuman epidermal growth factor receptor 2Objective response ratePhase II studyWhole-exome sequencingEribulin 1.4II studyTreatment landscapeCohort AEribulin mesylateDay 1Genomic alterationsMetastatic breast cancer settingEpidermal growth factor receptor 2More frequent alterationsBreast cancer settingModest clinical activityGrowth factor receptor 2Metastatic breast cancerResponse/resistanceFactor receptor 2Manageable toxicityPertuzumab exposurePrimary endpointSix patientsCohort BARC-9: Phase Ib/II study to evaluate etrumadenant (AB928)-based treatment combinations in patients with metastatic colorectal cancer (mCRC).
Cecchini M, Krishnan K, Giafis N, Scott J, Quah C, Bendell J. ARC-9: Phase Ib/II study to evaluate etrumadenant (AB928)-based treatment combinations in patients with metastatic colorectal cancer (mCRC). Journal Of Clinical Oncology 2021, 39: tps150-tps150. DOI: 10.1200/jco.2021.39.3_suppl.tps150.Peer-Reviewed Original ResearchMetastatic colorectal cancerStandard-of-careStandard-of-care armMFOLFOX-6Cohort BCohort AActivation of effector T cellsModified 5-fluorouracilTreated with FOLFOXDying cancer cellsDose-escalation studyEffector T cellsPhase Ib/II studyAdenosine receptor blockadeAdenosine receptor antagonistPhase 1b/2Escalation studyCurative intentReceptor blockadeOpen-labelImmunosuppressive adenosineCombination therapyPrimary endpointReceptor antagonistCohort C
2020
LTBK-01. INO-5401 AND INO-9012 DELIVERED INTRAMUSCULARLY (IM) WITH ELECTROPORATION (EP) IN COMBINATION WITH CEMIPLIMAB (REGN2810) IN NEWLY DIAGNOSED GLIOBLASTOMA
Reardon D, Brem S, Desai A, Bagley S, Kurz S, De La Fuente M, Nagpal S, Welch M, Hormigo A, Forsyth P, Mandell J, Khagi S, Aiken R, Walbert T, Lieberman F, Portnow J, Batiste J, Carroll N, Sylvester A, Campbell P, Lowy I, Dolgoter A, Boyer J, Kraynyak K, Morrow M, McMullan T, Weiner D, Skolnik J. LTBK-01. INO-5401 AND INO-9012 DELIVERED INTRAMUSCULARLY (IM) WITH ELECTROPORATION (EP) IN COMBINATION WITH CEMIPLIMAB (REGN2810) IN NEWLY DIAGNOSED GLIOBLASTOMA. Neuro-Oncology 2020, 22: ii237-ii237. PMCID: PMC7678727, DOI: 10.1093/neuonc/noaa215.988.Peer-Reviewed Original ResearchCohort AMedian OSAntigen-specific T cell responsesImmune responseRobust systemic immune responsesInterferon-gamma ELISPOTDiagnosed GBM patientsT cell responsesEncoding tumor antigensAdverse event profileNewly diagnosed glioblastomaPeripheral immune responseSystemic immune responsesCheckpoint inhibitionPD-1Diagnosed GBMDiagnosed glioblastomaOverall survivalCohort B.Tumor antigensCD8+T cellsMedian agePrimary endpointCohort BEvent profilePembrolizumab (pembro) plus mFOLFOX7 or FOLFIRI in patients (pts) with metastatic colorectal cancer (mCRC): Updated results from KEYNOTE-651 cohorts B and D
Kim R, Chaves J, Kavan P, Fakih M, Kortmansky J, Spencer K, Wong L, Tehfe M, Li J, Eyring A, Mayo C, Chiorean E. Pembrolizumab (pembro) plus mFOLFOX7 or FOLFIRI in patients (pts) with metastatic colorectal cancer (mCRC): Updated results from KEYNOTE-651 cohorts B and D. Annals Of Oncology 2020, 31: s450. DOI: 10.1016/j.annonc.2020.08.604.Peer-Reviewed Original ResearchPhase I dose-escalation trial of tucatinib in combination with trastuzumab in patients with HER2-positive breast cancer brain metastases
Filho O, Leone JP, Li T, Tan-Wasielewski Z, Trippa L, Barry WT, Younger J, Lawler E, Walker L, Freedman RA, Tolaney SM, Krop I, Winer EP, Lin NU. Phase I dose-escalation trial of tucatinib in combination with trastuzumab in patients with HER2-positive breast cancer brain metastases. Annals Of Oncology 2020, 31: 1231-1239. PMID: 32461105, DOI: 10.1016/j.annonc.2020.05.014.Peer-Reviewed Original ResearchConceptsClinical benefit rateHER2-positive brain metastasesAlanine aminotransferase elevationCohort ABrain metastasesCohort BAminotransferase elevationBreast cancerHER2-positive breast cancer brain metastasesPhase I dose-escalation trialMedian progression-free survivalBreast cancer brain metastasesCommon dose-limiting toxicityI dose-escalation trialHER2-positive breast cancerCombination of tucatinibSecondary end pointsCancer brain metastasesDose-escalation trialProgression-free survivalDose-limiting toxicityMetastatic breast cancerBrain radiationObjective responseIntracranial activityINO-5401 and INO-9012 delivered intramuscularly (IM) with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma (GBM): Interim results.
Reardon D, Brem S, Desai A, Bagley S, Kurz S, De La Fuente M, Nagpal S, Welch M, Hormigo A, Carroll N, Bartra S, Campbell P, Bhatt K, Lowy I, Boyer J, Kraynyak K, Morrow M, McMullan T, Weiner D, Skolnik J. INO-5401 and INO-9012 delivered intramuscularly (IM) with electroporation (EP) in combination with cemiplimab (REGN2810) in newly diagnosed glioblastoma (GBM): Interim results. Journal Of Clinical Oncology 2020, 38: 2514-2514. DOI: 10.1200/jco.2020.38.15_suppl.2514.Peer-Reviewed Original ResearchNewly-diagnosed GBMTumor inflammationCohort AT cell responsesNewly diagnosed glioblastomaWeeks of treatmentCheckpoint inhibitionPD-1Cohort B.Combination therapyPrimary endpointCD8+T cellsPhase I/IICohort BPlatelet countLymphocyte countSafety profileCemiplimabSurvival advantageCohort studyLytic potentialFlow cytometryPatientsGlioblastomaCohortP858 An open-label, multi-center trial of INO-5401 and INO-9012 delivered by electroporation (EP) in combination with cemiplimab in subjects with newly-diagnosed glioblastoma (GBM)
Skolnik J, Reardon D, Brem S, Desai A, Bagley S, Kurz S, de la Fuente M, Nagpal S, Welch M, Sacchetta B, Bartra S, Bredlau A, Lowy I, Kraynyak K, Morrow M, McMullan T, Boyer J. P858 An open-label, multi-center trial of INO-5401 and INO-9012 delivered by electroporation (EP) in combination with cemiplimab in subjects with newly-diagnosed glioblastoma (GBM). Journal For ImmunoTherapy Of Cancer 2020, 8: a8. DOI: 10.1136/lba2019.12.Peer-Reviewed Original ResearchNewly-diagnosed GBMCheckpoint inhibitorsCheckpoint inhibitionOverall survivalCohort ASafety profileClinical efficacyPD-1 checkpoint inhibitorsImmune-related AECycles of temozolomideT cell responsesNewly-diagnosed glioblastomaWeeks of treatmentPreliminary clinical efficacyMulti-center trialInstitutional ethics boardMaintenance temozolomidePD-1Open-labelCohort B.Median agePhase I/IICohort BCemiplimabAdverse eventsBeyond an Updated Graded Prognostic Assessment (Breast GPA): A Prognostic Index and Trends in Treatment and Survival in Breast Cancer Brain Metastases From 1985 to Today
Sperduto PW, Mesko S, Li J, Cagney D, Aizer A, Lin NU, Nesbit E, Kruser TJ, Chan J, Braunstein S, Lee J, Kirkpatrick JP, Breen W, Brown PD, Shi D, Shih HA, Soliman H, Sahgal A, Shanley R, Sperduto W, Lou E, Everett A, Boggs DH, Masucci L, Roberge D, Remick J, Plichta K, Buatti JM, Jain S, Gaspar LE, Wu CC, Wang TJC, Bryant J, Chuong M, Yu J, Chiang V, Nakano T, Aoyama H, Mehta MP. Beyond an Updated Graded Prognostic Assessment (Breast GPA): A Prognostic Index and Trends in Treatment and Survival in Breast Cancer Brain Metastases From 1985 to Today. International Journal Of Radiation Oncology • Biology • Physics 2020, 107: 334-343. PMID: 32084525, PMCID: PMC7276246, DOI: 10.1016/j.ijrobp.2020.01.051.Peer-Reviewed Original ResearchConceptsDiagnosis-specific prognostic factorsHuman epidermal receptor 2Prognostic factorsMedian survivalBreast-GPABrain metastasesBreast cancerCohort BCohort APrognostic indexReceptor 2Tumor subtypesBreast cancer brain metastasesKaplan-Meier survival estimatesCancer brain metastasesGraded Prognostic AssessmentKarnofsky performance statusLarge contemporary cohortLog-rank testFuture clinical trialsNew prognostic factorsGPA 0Extracranial metastasesPerformance statusBetter prognosis
2019
608P Pembrolizumab (pembro) plus mFOLFOX or FOLFIRI in patients with metastatic colorectal cancer (mCRC): KEYNOTE-651 cohorts B and D
Kim R, Chaves J, Kavan P, Fakih M, Kortmansky J, Spencer K, Wong L, Tehfe M, Li J, Lee M, Mayo C, Marinello P, Chiorean E. 608P Pembrolizumab (pembro) plus mFOLFOX or FOLFIRI in patients with metastatic colorectal cancer (mCRC): KEYNOTE-651 cohorts B and D. Annals Of Oncology 2019, 30: v229-v230. DOI: 10.1093/annonc/mdz246.085.Peer-Reviewed Original ResearchMetastatic colorectal cancerTreatment-related AEsSubsidiary of MerckCohort BCohort DDohme Corp.Merck SharpEastern Cooperative Oncology Group performance status 0/1Stage IV metastatic colorectal cancerArray BioPharmaOxaliplatin-based regimenPerformance status 0/1Phase 2 dosePrior systemic chemotherapySafety/tolerabilityObjective response ratePD-1 inhibitorsDose-limiting toxicitySmall intestinal obstructionData cutoffImmunotherapy agentsSystemic chemotherapyMethods PatientsColorectal cancerEMD SeronoTRLS-03. PHASE II TRIAL OF GDC-0084 IN COMBINATION WITH TRASTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER BRAIN METASTASES (BCBM)
Leone J, Trippa L, Milisits L, Andrews C, Ligibel J, Parsons H, Bi W, Zhao J, Winer E, Lin N. TRLS-03. PHASE II TRIAL OF GDC-0084 IN COMBINATION WITH TRASTUZUMAB FOR PATIENTS WITH HER2-POSITIVE BREAST CANCER BRAIN METASTASES (BCBM). Neuro-Oncology Advances 2019, 1: i9-i9. PMCID: PMC7213424, DOI: 10.1093/noajnl/vdz014.036.Peer-Reviewed Original ResearchBreast cancer brain metastasesObjective response rateCohort BCohort ACNS metastasesPrimary endpointHER2-positive breast cancer brain metastasesNeuro-Oncology Brain Metastases criteriaCentral nervous system metastasesHER2-positive breast cancerPatient-derived xenografts (PDX) modelsPhase II cohortNervous system metastasesPhase II studyCancer brain metastasesPhase II trialPI3K/Akt/mTORPatient-reported outcomesPI3KBrain-penetrant inhibitorAkt/mTORCombination of GDCMetastasis (TNM) criteriaBrain metastasesII trialAntitumor activity and safety of pembrolizumab in patients with advanced recurrent ovarian cancer: results from the phase II KEYNOTE-100 study
Matulonis UA, Shapira-Frommer R, Santin AD, Lisyanskaya AS, Pignata S, Vergote I, Raspagliesi F, Sonke GS, Birrer M, Provencher DM, Sehouli J, Colombo N, González-Martín A, Oaknin A, Ottevanger PB, Rudaitis V, Katchar K, Wu H, Keefe S, Ruman J, Ledermann JA. Antitumor activity and safety of pembrolizumab in patients with advanced recurrent ovarian cancer: results from the phase II KEYNOTE-100 study. Annals Of Oncology 2019, 30: 1080-1087. PMID: 31046082, DOI: 10.1093/annonc/mdz135.Peer-Reviewed Original ResearchConceptsRecurrent ovarian cancerObjective response rateDisease control rateProgression-free survivalTreatment-free intervalDuration of responseAdvanced recurrent ovarian cancerPD-L1 expressionPlatinum-free intervalCohort AOverall survivalPrior linesCohort BOvarian cancerHigh PD-L1 expressionLow objective response rateMedian DORSolid Tumors version 1.1End pointGynecologic cancer-related deathBlinded independent central reviewSafety of pembrolizumabSingle-agent pembrolizumabMedian overall survivalPhase II study
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