Digital Breast Tomosynthesis QC Requirements

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Digital Breast TomosynthesisQC RequirementsAAPMSpring Clinical MeetingMarch 8, 2015Michael S Glaser, MS, DABRAlliance Medical Physics, LLC

Learning Objectives1. GE SenoClaire - Physicist & Technologist QC2. Hologic Selenia Dimensions 3D- Physicist &Technologist QC

Disclosures Funding Support- None Conflicts of Interest- None Disclosures- Yes, vendor QC slidesSpecial Thanks for vendor QC slides, courtesy of: Razvan Iordache, PhD of GE Healthcare Nikos Gkanatsios ,PhD of Hologic

Quality Control for SenoClaire(GE Breast Tomosynthesis)

SenoClaire Key Features 9 ProjectionsStop-and-shootSweep angle 25 ( /- 12.5)Sweep time 10 sec*Detector pixel size 100 um in 2D & 3D2D/3D-grid for scatter reductionASIRDBT Iterative ReconstructionNo dose increase (3D vs. 2D)BTO DICOM format(Breast Tomosynthesis Object).9Comment: *Exposure time depends on breast thickness, ; 10 sec for average breast of 4.5cm PMMA.SenoClaire (GE Breast Tomosynthesis)

SenoClaire is an Upgrade forSenographe EssentialMotorized Tomosynthesis Device(MTD).Senographe EssentialSenographe EssentialUpgraded with SenoClaire

Imaging with the MTDTraditional antiscatter grid - EssentialView of system positioned for a left MLO view2D/3D antiscatter grid – SenoClaire’s MTDView of system positioned for a left MLO viewBoth 2D & 3D imaging is performed with the MTD5

SenoClaire QC ManualThis quality control (QC) manualadds tests specific to SenoClaire tothose listed in the SenographeEssential QC manual71 pages6

SenoClaire QC – Radiologic Technologist7

QC Tests for the Radiologic TechnologistEssentialSenoClaire (w/ MTD)No XNo XMinimumfrequencyTestDailyMonitor cleaningWeeklyFlat fieldXWeeklyPhantom IQXWeeklyCNR & MTFX XWeeklyViewbox & ViewingMonthlyAOP Mode & SNRXXMonthlyVisual ChecklistXQuaterlyRepeat AnalysisXSemianuallyCompression ForcexMonthlyGrid Texture2D2D3DXXX XX XXxX8

QC Tests for the Radiologic TechnologistEssentialSenoClaire (w/ MTD)No XNo XMinimumfrequencyTestDailyMonitor cleaningWeeklyFlat fieldXWeeklyPhantom IQXWeeklyCNR & MTFX XWeeklyViewbox & ViewingMonthlyAOP Mode & SNRXXMonthlyVisual ChecklistXQuaterlyRepeat AnalysisXSemianuallyCompression ForcexMonthlyGrid Texture2D2D3DXXX XX XXxX9

SenoClaire Tests same as Essential TestsEssentialSenoClaire (w/ MTD)No XNo XMinimumfrequencyTestDailyMonitor cleaningWeeklyFlat fieldXWeeklyPhantom IQXWeeklyCNR & MTFX XWeeklyViewbox & ViewingMonthlyAOP Mode & SNRXXMonthlyVisual ChecklistXQuaterlyRepeat AnalysisXSemianuallyCompression ForcexMonthlyGrid Texture2D2D3DXXX XX XXxX10

SenoClaire Tests specific Visual ChecklistEssentialSenoClaire (w/ MTD)No XNo XMinimumfrequencyTestDailyMonitor cleaningWeeklyFlat fieldXWeeklyPhantom IQXWeeklyCNR & MTFX XWeeklyViewbox & ViewingMonthlyAOP Mode & SNRXXMonthlyVisual ChecklistXQuaterlyRepeat AnalysisXSemianuallyCompression ForcexMonthlyGrid Texture2D2D3DXXX XX XXxX11

Visual Checklist (monthly)ObjectiveTo assure that GE Breast Tomosynthesis indicatorlights, displays, and mechanical locks and detentsare working properly and that the system ismechanically stable.Equipment requiredVisual checklist Chart 5. Grid texture test, Visual Checklist andCompression Record of Checks (page 36).Procedure Review each item on the visual checklist and indicate its statusAction LimitEach of the items listed in the Visual Checklist must pass (ie, receive acheck mark)12

SenoClaire Tests New Grid Texture TestEssentialSenoClaire (w/ MTD)No XNo XMinimumfrequencyTestDailyMonitor cleaningWeeklyFlat fieldXWeeklyPhantom IQXWeeklyCNR & MTFX XWeeklyViewbox & ViewingMonthlyAOP Mode & SNRXXMonthlyVisual ChecklistXQuaterlyRepeat AnalysisXSemianuallyCompression ForcexMonthlyGrid Texture2D2D3DXXX XX XXxX13

Grid Texture Test (monthly)ObjectiveMeasures the amount of grid texture in 2D imagesEquipment requiredFlat field test objectProcedure Automatic acquisition of 10 2D images with increasing mAs Record the dispayed test resultsAction LimitThe texture level must not exceed 0.00214

Grid Texture Test (monthly)Noise vs dose14000Noise [counts]1200010000y 0.0101x2 0.0681x - 0.8385800060004000200000200400600800Detector dose [nGy]1000120015

SenoClaire Tests 3D “Extensions”EssentialSenoClaire (w/ MTD)No XNo XMinimumfrequencyTestDailyMonitor cleaningWeeklyFlat fieldXWeeklyPhantom IQXWeeklyCNR & MTFWeeklyViewbox & ViewingMonthlyAOP Mode & SNRMonthlyVisual ChecklistXQuaterlyRepeat AnalysisXSemianuallyCompression ForcexMonthlyGrid Texture2D2D3DXXX X XXXXX XXxX16

Flat field 3D Test (Weekly)ObjectiveEnsure flatness and homogeneity whenreconstructing planes through a flat field phantomEquipment requiredFlat field test objectProcedure Automatic 3D acquisitiion Record the displayed test resultsAction LimitBoth Brightness non-uniformity* and SNR non-uniformity* tests mustpass* Calculated in the plane at 10 mm height17

Phantom IQ 3D Test (Weekly)ObjectiveEnsure adequate and consistent IQ of 3D imagesEquipment requiredACR mammography accreditation phantomProcedure 3D acquisitiion with Rh/Rh track/filter, 29 kV, 56 mAs Review the volumes; “score” the phantomScroll through the volume to find the bestin-focus plane for each structure!Action LimitThe score must be: Fibers 4, Speck groups 3, Masses 3Same technique & action limit as for the 2D test18

AOP 3D Check (Monthly)ObjectiveCheck that the correct parameters are selected in AOP 3D modeEquipment requiredSet of acrylic plates (same as for the AOP 2D Check)Procedure 3D AOP acquisition on 25mm, 50mm, and 60 mm of acyrlic Record the exposure parametersAction LimitAcrylicThickness(mm)Track/FiltermAskV25Mo/Mo or Mo/Rh20-702650Rh/Rh40-902960Rh/Rh50-12030 or 31Exposure parameters19

AOP 3D Check (Monthly)Displayed results20

SenoClaire QC Tests for the Technologist 2D Tests:- Section 3: Phantom IQ Test with MTD - Checks for consistency of image quality.- Section 4: CNR and MTF Measurement with MTD - Checks for consistent productionof good contrast images.- Section 8: AOP 2D and SNR Check with MTD - Checks for correct operation of AOPmode with MTD. MTD Test: Section 7: Grid Texture Test - Checks for consistency of image qualityregarding grid texture. 3D Tests:- Section 5: Flat-field 3D Test - Checks for consistency of image quality.- Section 6: Phantom IQ 3D Test - Checks for consistency of image quality.- Section 9: AOP 3D Test - Checks for correct operation of AOP mode in 3D. Section 10: Visual Checklist (page 27). Section 11: Compression Force Test - Checks for the correct level of compression force. Section 12: Test Results Forms - Provides charts for use in recording test results. It isrecommended that you copy these chart pages to record test results.For record keeping and further analysis, data generated on the Acquisition Workstation(AWS) for Flat-field, CNR, MTF, AOP and SNR tests can be exported as text files to a CD-R.21

SenoClaire QC – Medical Physicist22

QC Tests for the Medical PhysicistTestEssentialnoX2DSenoClaire (w/ MTD)noX2DFlat fieldXPhantom IQXXCNR & MTFXXAOP Mode & SNRXXArtifact Eval & Flat field UnifXXCollimation (2 alternatives)XSub-system MTF or Focal Spot PerfXBreast Entrance Expose, AGD, ReproducibilityXFlexible paddle deflectionXHVLXGrid TextureCompression paddle border to chestwall alignmentVolume CoverageXXXXXXkVp Accuracy and ReproducibilityMammo Unit Assembly Eval3DX XXX23

QC Tests for the Medical PhysicistTestEssentialnoX2DSenoClaire (w/ MTD)noX2DFlat fieldXPhantom IQXXCNR & MTFXXAOP Mode & SNRXXArtifact Eval & Flat field UnifXXCollimation (2 alternatives)XSub-system MTF or Focal Spot PerfXBreast Entrance Expose, AGD, ReproducibilityXFlexible paddle deflectionXHVLXGrid TextureCompression paddle border to chestwall alignmentVolume CoverageXXXXXXkVp Accuracy and ReproducibilityMammo Unit Assembly Eval3DX XXX24

Test Intervals – all at acceptance and at leastannually7 tests from radiologic technologist‘s section5 additional only for medical physicists

SenoClaire Tests same as Essential TestsTestEssentialnoX2DSenoClaire (w/ MTD)noX2DFlat fieldXPhantom IQXXCNR & MTFXXXXXXAOP Mode & SNRArtifact Eval & Flat field UnifCollimation (2 alternatives) XBreast Entrance Expose, AGD, ReproducibilityXkVp Accuracy and ReproducibilityXXXXXMammo Unit Assembly EvalXGrid Texture Volume CoverageXX HVLCompression paddle border to chestwall alignmentXXSub-system MTF or Focal Spot PerfFlexible paddle deflection3DXXX26

Compression paddle to MTD chest wallalignment testObjectiveAssure that the paddle chest wall side border aligns with the chest wallside of the MTDSame test as “Compression Paddle Chest Wall Test” from theCollimation Assessment tests for Essential (541589-3-1EN)- Job Card VF-P01A - Collimation Assessment with X-Ray Cassette, OR- Job Card VF-P01B - Collimation Assessment with Radiation SensitiveStrips27

SenoClaire Tests New Grid Texture TestTestEssentialnoX2DSenoClaire (w/ MTD)noX2DFlat fieldXPhantom IQXXCNR & MTFXXXXXXAOP Mode & SNR Artifact Eval & Flat field Unif Collimation (2 alternatives)XBreast Entrance Expose, AGD, ReproducibilityXXkVp Accuracy and Reproducibility HVLMammo Unit Assembly EvalGrid TextureCompression paddle border to chestwall alignmentVolume CoverageXXXXSub-system MTF or Focal Spot PerfFlexible paddle deflection3DXXXXX XXX28

SenoClaire Tests 3D “Extensions”TestEssentialnoX2DSenoClaire (w/ MTD)noX2DFlat fieldXPhantom IQXXCNR & MTFXXXXXXAOP Mode & SNR Artifact Eval & Flat field Unif Collimation (2 alternatives)XBreast Entrance Expose, AGD, ReproducibilityXXkVp Accuracy and Reproducibility HVLMammo Unit Assembly EvalGrid TextureCompression paddle border to chestwall alignmentVolume CoverageXXXXSub-system MTF or Focal Spot PerfFlexible paddle deflection3DXXXXX XXX29

3D Breast Entrance Exposure and AGDObjectiveMeasure the typical entrance exposure in 3D mode ona “standard breast” (42-mm 50% fibroglandular);calculate the delivered AGDEquipment requiredDosimeter & ACR Mammography accreditation phantomProcedure 3D stationary* acquisition in manual mode acquisition technique should be as close as possible to techniqueclinically used on a “standard breast” From the measured Entrance exposure compute the AGD Action LimitThe AGD for a “standard breast” must not exceed 3 mGy per 3D acquisitionSame procedure as for the 2D test but entrance dosemeasured over a sequence of 9 low-dose acquisitions30* “3D” acquisitions with the tube non-moving (at zero degree)

SenoClaire Tests New 3D Specific TestTestEssentialnoX2DSenoClaire (w/ MTD)noX2DFlat fieldXPhantom IQXXCNR & MTFXXXXXXAOP Mode & SNR Artifact Eval & Flat field Unif Collimation (2 alternatives)XBreast Entrance Expose, AGD, ReproducibilityXXkVp Accuracy and Reproducibility HVLMammo Unit Assembly EvalGrid TextureCompression paddle border to chestwall alignmentVolume CoverageXXXXSub-system MTF or Focal Spot PerfFlexible paddle deflection3DXXXXX XXX31

Volume CoverageObjectiveEnsure that the entire imaged objectis reconstructed on the Z-axis(perpendicular to the detector)Equipment requiredSet of acrylic plates; 2 1-mm Al sheetsProcedure “Sandwich“ 25 mm of acrylic plates in between the 2 Al sheets asshowed in the picture Manual 3D exposure, clinically used compression force Search for the focal planes for the 2 Al sheets Repeat with 60 mm acrylicAction LimitThe focal planes for the 2 Al planes must be in the reconstructed volume32

Volume Coverage33

SenoClaire Quality Control Forms34

ConclusionAdditional QC Tests for SenoClaire (with MTD installed)Technologist Tests1.2.3.4.5.6.7.8.9.Phantom IQ 2D Test with MTDCNR and MTF Measurement with MTDFlat-field 3D TestPhantom IQ 3D TestMTD Grid Texture TestAOP 2D and SNR Check with MTDAOP 3D CheckVisual ChecklistCompression Force TestWeeklyMonthlySemi-annuallyMedical Physicist Tests (in addition to repeating those above)1.2.3.4.5.Compression paddle to chest wall alignment with MTDBreast Entrance Exposure and AGD in 2D with MTDBreast Entrance Exposure and AGD in 3D ModeArtifact Evaluation and Flat-field Uniformity with MTDVolume Coverage of DBTAnnually35

DBT QUALITY CONTROL PROCEDURESQuality Control Procedures:Digital Breast TomosynthesisSelenia Dimensions DigitalBreast Tomosynthesis Systems

S Y S T EDBTM DQUALITYE S C R I P TCONTROLI O N A N D PROCEDURESUSER INTERFACESystemDescription

DBT QUALITY CONTROL PROCEDURESImage Acquisition Modes Conventional– Acquires 2D images, only Tomo– Acquires tomosynthesis images,only TomoHD– Acquires tomosynthesis images,only– Produces C-View images Combo– Acquires 2D images– Acquires tomosynthesis images ComboHD– Acquires 2D images– Acquires tomosynthesis images– Produces C-View images

DBT QUALITY CONTROL PROCEDURESQC Modes Quality controlprocedures test––––ConventionalTomoComboiView The following modesdo not requireseparate QC testing– TomoHD– ComboHD

DBT QUALITY CONTROL PROCEDURESAWS ConfigurationsWith AWS-8000(premium version)With AWS-5000(standard version)

DBT QUALITY CONTROL PROCEDURESX-Ray GenerationX-Ray TubeX-Ray FiltrationX-Ray Generator Tungsten (W) Anode LFS: 0.3 mm; SFS: 0.1 mm Conv: 50 μm Rh; 50 μm Ag Tomo: 0.7 mm Al 200 mA max for LFS 50 mA max for SFS Max mA varies with kVp mA adjusts to target time range

DBT QUALITY CONTROL PROCEDURESSelenia Dimensions: TechniquesConventional 2D ImagingTomosynthesis Imaging a-Se detector, 24 29 cm area70 μm pixel sizeRh and Ag filtersHTC grid in contact mode;HTC (High Trans. Cellular) 20-39 kVpa-Se detector, 24 29 cm area140 μm pixel sizeAl filterNo anti-scatter gridMoving tube, 15 sweepMoving detector15 projections 4 seconds acquisitionReconstruction– 100 μm pixel size– 1 mm slice spacing 20-49 kVp

S Y S T EDBTM DQUALITYE S C R I P TCONTROLI O N A N D PROCEDURESUSER INTERFACEDBTQuality Control

DBT QUALITY CONTROL PROCEDURESSelenia Dimensions QC Manual mography ographyThe QC manual covers:- Selenia Dimensions 2D FFDM system- Selenia Dimensions DBT system- Current revisions:- MAN-01965 R008, Jul 2014- MAN-03706 R002, Aug 2014

DBT QUALITY CONTROL PROCEDURESMedical PhysicsQC Tests12 tests to be performed bythe medical physicist7 of them have DBTcomponents/requirements

DBT QUALITY CONTROL PROCEDURESTomosynthesis Option Tomosynthesis specifictests are marked with anicon Icon indicates that aspecial action is requiredunder tomosynthesisNOTE: When testing FFDM only,these instructions are ignored

S Y S T EDBTM DQUALITYE S C R I P TCONTROLI O N A N D PROCEDURESUSER INTERFACEQuality ControlTests

MP Tests for Dimensions 2D10

MP Tests with Tomosynthesis Option11

Technologist Tests – Dimensions 2D12

Technologist Tests –Tomosynthesis Option13

DBT QUALITY CONTROL PROCEDURESFollow the 1999 ACR Mammography Quality Control Manual1. MAMMOGRAPHIC UNITASSEMBLY EVALUATION

DBT QUALITY CONTROL PROCEDURESFollow the Hologic Selenia Dimensions Quality Control Manual2. COLLIMATOR ASSESSMENT

DBT QUALITY CONTROL PROCEDURES2a. X-Ray Field to Light Field ONLY use the 24x29 cm compressionpaddle Cover the image receptor if repeated, highexposures are required (i.e. self-developingfilm)

DBT QUALITY CONTROL PROCEDURES2b. X-Ray Field to Image Receptor Test with the 24x29 cm compression paddle Test left, center and right x-ray fields with the 18x24cm compression paddle Use the Zero-Degree Tomo view to test undertomosynthesis Follow the directions in the QC manual

DBT QUALITY CONTROL PROCEDURES2c. Compression Paddle to ImageReceptor Compression paddles––––Manufactured as single piecesDo not have adjusting partsDesigned to comply with the regulationsDesign assumes mild compression ( 10lb) to remove play

DBT QUALITY CONTROL PROCEDURESFollow the Hologic Selenia Dimensions Quality Control Manual3. ARTIFACT EVALUATION

DBT QUALITY CONTROL PROCEDURESProcedure Highlights DICOM printer– Send an artificial flat fieldimage to the printer FFDM testing– Test all focus/filtercombinations (LFS/Rh;LFS/Ag; SFS/Rh; SFS/Ag)– Preview image in fullresolution DBT testing– Test using middleprojection– Preview image in fullresolution

DBT QUALITY CONTROL PROCEDURESFollow the 1999 ACR Mammography Quality Control Manual4. KVP ACCURACY ANDREPRODUCIBILITY

DBT QUALITY CONTROL PROCEDURESProcedure Highlights Cover the image receptor to protect it from radiation exposure FFDM extends to 39 kVp; DBT extends to 49 kVp Use the Zero-Degree Tomo mode to test beyond 39 kVp, ifneeded Non-invasive meters must be calibrated to the specific filtersand energy range used Hologic Service can assist with equipment

DBT QUALITY CONTROL PROCEDURESFollow the 1999 ACR Mammography Quality Control Manual5. BEAM QUALITY ASSESSMENT—HVL MEASUREMENT

DBT QUALITY CONTROL PROCEDURESProcedure Highlights Cover the image receptor to protect it from radiation exposureUse the Zero-Degree Tomo mode to measure HVL under DBT (Alfilter)NOTE: compression thickness should be 24cm for the system toallow exposureNon-invasive meters must be calibrated to the specific filters andenergy range used[HVL (kVp/100) 0.03] in mm Al

DBT QUALITY CONTROL PROCEDURESFollow the Hologic Selenia Dimensions Quality Control Manual6. EVALUATION OF SYSTEMRESOLUTION

DBT QUALITY CONTROL PROCEDURESProcedure Highlights Place the line pairphantom on top of the4 cm acrylic c Rotate the line pairphantom 45 Apply 15-20 lb ofcompression to avoidvibration during DBT Use the Flat Field view(no image processing) Resolution guidelines:– FFDM: 7 lp/mm @45 – DBT: 3 lp/mm @ 45

DBT QUALITY CONTROL PROCEDURESProcedure Highlights

DBT QUALITY CONTROL PROCEDURESFollow the Hologic Selenia Dimensions Quality Control Manual7. AEC FUNCTIONPERFORMANCE

DBT QUALITY CONTROL PROCEDURESAEC Function Description AEC modes– Auto-Filter– Auto-kV– Auto-Time AEC positions– Auto AEC: 2, 1cm2 floating sensors at 5x14cm2 area– One of seven manual positions (marked on compressionpaddle) AEC function– kVp and filter parameters are determined by compressionthickness and AEC technique tables– Starting mAs is determined from short pre-exposure targetinga specific exposure index (EI)– Final mAs is adjusted by CNR correction factor

DBT QUALITY CONTROL PROCEDURESProcedure Highlights Compression thicknessmust be set using thecompression display FFDM testing– Range of phantomthickness– Different operatingmodes (i.e. mag)– Exposure compensationsteps DBT testing– Range of phantomthickness

DBT QUALITY CONTROL PROCEDURESExposure Index (EI) EI is defined as thedigital value of adetector element “Raw” EI values needto be corrected by– Subtracting the DC𝑅𝑂𝐼 𝑚𝑒𝑎𝑛 𝐷𝐶 𝑂𝑓𝑓𝑠𝑒𝑡offset (value of 50)𝑃𝑖𝑥𝑒𝑙 𝑉𝑎𝑙𝑢𝑒 𝐶𝑁𝑅 𝐶𝑜𝑟𝑟𝑒𝑐𝑡𝑖𝑜𝑛 𝐹𝑎𝑐𝑡𝑜𝑟– Normalizing by theCNR correction factor(given in Appendix Dof the Hologic QCManual)

DBT QUALITY CONTROL PROCEDURESCNR Correction Factors, FFDMLFS

DBT QUALITY CONTROL PROCEDURESCNR Correction Factors, FFDMSFS

DBT QUALITY CONTROL PROCEDURESCNR Correction Factors, FFDMLFS

DBT QUALITY CONTROL PROCEDURESCalculation Example

DBT QUALITY CONTROL PROCEDURESFollow the Hologic Selenia Dimensions Quality Control Manual8. BREAST ENTRANCE EXPOSURE,AEC REPRODUCIBILITY AND AGD

DBT QUALITY CONTROL PROCEDURESProcedure Highlights Wait until the imagereceptor goes fromWarming to Readystatus Use ACR Phantomview to overwritecompressionthickness to 4.2 cm

DBT QUALITY CONTROL PROCEDURESProcedure Highlights Test AGD in all threemodes– FFDM– DBT– Combo Hologic AGDrecommended dosefor ACR phantom– FFDM: 1.2 mGy– DBT: 1.45 mGy Performance criteria– AGD 3 mGy

DBT QUALITY CONTROL PROCEDURESFollow the Hologic Selenia Dimensions Quality Control Manual10. PHANTOM IMAGE QUALITYEVALUATION

DBT QUALITY CONTROL PROCEDURESProcedure Highlights Wait until the imagereceptor goes fromWarming to Readystatus Use ACR Phantomview to overwritecompressionthickness to 4.2 cm

DBT QUALITY CONTROL PROCEDURESPhantom Scoring Score phantom on AWSdisplay Review image in fullresolution FFDM scoring– 5 fibers, 4 specs, 4 masses– Due to phantom variations ascore of 4.5/4.0/3.5 isacceptable providing SNRand high contrast resolutiontests pass DBT scoring– Scroll to the slice that putsthe different elements infocus– 4 fibers, 3 specs, 3 masses

DBT QUALITY CONTROL PROCEDURESFollow the Hologic Selenia Dimensions Quality Control Manual11. SNR AND CNR MEASUREMENTS

DBT QUALITY CONTROL PROCEDURESProcedure Highlights Wait until the imagereceptor goes fromWarming to Ready status Use ACR Phantom viewto overwrite compressionthickness to 4.2 cm ACR Phantom viewallows automaticSNR/CNR calculations Test is performed underFFDM mode only

DBT QUALITY CONTROL PROCEDURESAutomatic Computation

Geometry Calibration

(AWS) for Flat-field, CNR, MTF, AOP and SNR tests can be exported as text files to a CD-R. SenoClaire QC – Medical Physicist 22 . Test Essential SenoClaire (w/ MTD) noX 2D noX 2D 3D Flat field X X Phantom IQ X X X CNR & MTF X X AOP Mode & SNR X X X Artifact Eval & Flat field Unif X X .

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