ID

11477

Description

NSABP Protocol B-40 - Tumor Response Form NCT00408408 A Randomized Phase III Trial of Neoadjuvant Therapy in Patients With Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel When Administered Before AC With or Without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR With Each of the Regimens Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B7DC2CF-E4EE-1B7D-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=1B7DC2CF-E4EE-1B7D-E044-0003BA3F9857

Keywords

Versions (3)
  1. 12/18/14 12/18/14 - Martin Dugas
  2. 1/9/15 1/9/15 - Martin Dugas
  3. 7/5/15 7/5/15 -
Uploaded on

July 5, 2015

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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NSABP Protocol B-40 - Tumor Response Form NCT00408408

English

No Instruction available.

1 forms  
  1. StudyEvent: NSABP Protocol B-40 - Tumor Response Form
    1. No Instruction available.
Header
Description

Header

Patient Initials (Last First Middle)
Description

Patient Initials

Data type

text

Alias
NCI Thesaurus ValueDomain
C25191
UMLS CUI-1
C2986440
NCI Thesaurus ObjectClass
C16960
NCI Thesaurus Property
C25536
NSABP Patient ID
Description

Patient ID NSABP

Data type

text

Alias
NCI Thesaurus ValueDomain
C25337
UMLS CUI-1
C2348585
NCI Thesaurus ObjectClass
C16960
UMLS CUI-2
C1513905
NCI Thesaurus Property
C25364
NCI Thesaurus Property-2
C15818
Reason Form Submitted
Description

SubmittedFormDescriptionReason

Data type

text

Alias
NCI Thesaurus ValueDomain
C25638
UMLS 2011AA ValueDomain
C0392360
NCI Thesaurus ObjectClass
C19464
UMLS 2011AA ObjectClass
C0376315
NCI Thesaurus ObjectClass-2
C25695
UMLS 2011AA ObjectClass-2
C1515023
NCI Thesaurus Property
C25365
UMLS 2011AA Property
C0678257
Form completed by
Description

Form completed by

Institution/Affiliate
Description

CombinedInstitutionName

Data type

text

Person Completing Form, Last Name
Description

ResponsiblePersonLastName

Data type

text

Person Completing Form, First Name
Description

ResponsiblePersonFirstName

Data type

text

Person Completing Form, Phone
Description

ResponsiblePersonPhoneNumber

Data type

text

Are data amended
Description

DataAmendedInd-3

Data type

boolean

Target Lesions
Description

Target Lesions

Were the target lesions measured on this evaluation
Description

TargetLesionDimensionInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25702
UMLS 2011AA ObjectClass-2
C1521840
NCI Thesaurus Property
C25483
UMLS 2011AA Property
C0439534
Date of Evaluation
Description

LesionAssessmentDate

Data type

date

Alias
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C20989
UMLS 2011AA Property
C0031809
NCI Thesaurus ValueDomain-2
C25367
Response status of Target lesion (s)
Description

TargetLesionResponseStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus ObjectClass-2
C25702
UMLS 2011AA ObjectClass-2
C1521840
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
Lesion Number
Description

LesionSiteNumber

Data type

float

Alias
NCI Thesaurus ValueDomain
C25337
UMLS 2011AA ValueDomain
C0237753
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
Target Lesion Site
Description

LesionTargetLocationType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25341
UMLS 2011AA Property
C0450429
NCI Thesaurus Property-2
C25702
UMLS 2011AA Property-2
C1521840
Longest Diameter of Lesion (s)
Description

Longest Diameter of Lesion

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ObjectClass
C3824
UMLS CUI-1
C0221198
NCI Thesaurus Property
C25285
UMLS CUI-2
C1301886
NCI Thesaurus Property-2
C25558
UMLS CUI-3
C1522425
NCI Thesaurus ValueDomain
C25209
NCI Thesaurus ValueDomain-2
C25285
cm
Sum of longest diameters of all target lesions (cm)
Description

LongestLesionSumDiameterMeasurement

Data type

float

Alias
NCI Thesaurus ObjectClass
C25558
UMLS 2011AA ObjectClass
C1522425
NCI Thesaurus ObjectClass-2
C3824
UMLS 2011AA ObjectClass-2
C0221198
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property-2
C25697
UMLS 2011AA Property-2
C1515051
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
Smallest Sum of Longest Diameters of all Target Lesions
Description

LesionLowestSumLongestDiameterMeasurement

Data type

float

Measurement units
  • cm
Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property-2
C25558
UMLS 2011AA Property-2
C1522425
NCI Thesaurus Property-3
C25697
UMLS 2011AA Property-3
C1515051
NCI Thesaurus Property-4
C43517
UMLS 2011AA Property-4
C1708760
NCI Thesaurus ValueDomain
C25209
UMLS 2011AA ValueDomain
C0242485
NCI Thesaurus ValueDomain-2
C25285
UMLS 2011AA ValueDomain-2
C1301886
cm
Date Smallest Sum Observed
Description

LesionLowestSumLongestDiameterDate

Data type

date

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25285
UMLS 2011AA Property
C1301886
NCI Thesaurus Property-2
C25558
UMLS 2011AA Property-2
C1522425
NCI Thesaurus Property-3
C25697
UMLS 2011AA Property-3
C1515051
NCI Thesaurus Property-4
C43517
UMLS 2011AA Property-4
C1708760
NCI Thesaurus ValueDomain
C25164
UMLS 2011AA ValueDomain
C0011008
Nontarget Lesions
Description

Nontarget Lesions

Were nontarget lesions identified on the baseline evaluation
Description

NontargetLesionBaselinePresentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25592
UMLS 2011AA ObjectClass-2
C1518389
NCI Thesaurus Property
C25626
UMLS 2011AA Property
C0150312
NCI Thesaurus Property-2
C25213
UMLS 2011AA Property-2
C1442488
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Were the nontarget lesions assessed on this evaluation
Description

NontargetLesionFollow-upAssessmentInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25592
UMLS 2011AA ObjectClass-2
C1518389
NCI Thesaurus Property
C25367
NCI Thesaurus Property-2
C16033
UMLS 2011AA Property
C1522577
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Response Status of NONTARGET Lesions
Description

Non-TargetLesionResponseStatus

Data type

text

Alias
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25592
UMLS 2011AA ObjectClass-2
C1518389
NCI Thesaurus Property
C25755
UMLS 2011AA Property
C0871261
NCI Thesaurus ValueDomain
C25688
UMLS 2011AA ValueDomain
C0449438
New Lesions
Description

New Lesions

Was the appearance of any new lesions documented
Description

NewLesionAppearanceInd-2

Data type

boolean

Alias
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus ObjectClass-2
C25586
UMLS 2011AA ObjectClass-2
C0205314
NCI Thesaurus Property
C25377
UMLS 2011AA Property
C0700364
New Lesion Site
Description

LesionNewLocationType

Data type

text

Alias
NCI Thesaurus ValueDomain
C25284
UMLS 2011AA ValueDomain
C0332307
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25586
UMLS 2011AA Property
C0205314
NCI Thesaurus Property-2
C25341
UMLS 2011AA Property-2
C0450429
Specify
Description

LesionNewLocationSpecify

Data type

text

Alias
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
NCI Thesaurus ObjectClass
C3824
UMLS 2011AA ObjectClass
C0221198
NCI Thesaurus Property
C25586
UMLS 2011AA Property
C0205314
NCI Thesaurus Property-2
C25341
UMLS 2011AA Property-2
C0450429
Was there any other manifestation of disease progression (other than progression of target lesions, progression of nontarget lesions, or the appearance of a new lesion)
Description

DiseaseOtherIndicationProgressionInd-2

Data type

boolean

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25331
NCI Thesaurus Property-3
C41184
UMLS 2011AA Property-2
C0392360
NCI Thesaurus ValueDomain
C38147
UMLS 2011AA ValueDomain
C1512698
Specify (If yes)
Description

DiseaseOtherIndicationProgressionSpecify

Data type

text

Alias
NCI Thesaurus ObjectClass
C2991
UMLS 2011AA ObjectClass
C0012634
NCI Thesaurus Property
C17649
UMLS 2011AA Property
C0205394
NCI Thesaurus Property-2
C25331
NCI Thesaurus Property-3
C41184
UMLS 2011AA Property-2
C0392360
NCI Thesaurus ValueDomain
C25685
UMLS 2011AA ValueDomain
C1521902
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1 forms
  1. StudyEvent: NSABP Protocol B-40 - Tumor Response Form
    1. No Instruction available.
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Header
Patient Initials
Item
Patient Initials (Last First Middle)
text
C25191 (NCI Thesaurus ValueDomain)
C2986440 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C25536 (NCI Thesaurus Property)
Patient ID NSABP
Item
NSABP Patient ID
text
C25337 (NCI Thesaurus ValueDomain)
C2348585 (UMLS CUI-1)
C16960 (NCI Thesaurus ObjectClass)
C1513905 (UMLS CUI-2)
C25364 (NCI Thesaurus Property)
C15818 (NCI Thesaurus Property-2)
Item
Reason Form Submitted
text
C25638 (NCI Thesaurus ValueDomain)
C0392360 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25695 (NCI Thesaurus ObjectClass-2)
C1515023 (UMLS 2011AA ObjectClass-2)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
CL.2
Code List
Reason Form Submitted
CL Item
Required Assessment At The End Of The Docetaxel Regimen (Required assessment at the end of the docetaxel regimen)
CL Item
Required Assessment At The End Of The Ac Cycles (Required assessment at the end of the AC cycles)
CL Item
Discretionary Assessment Which Identified Protocol-defined Progressive Disease (Discretionary assessment which identified protocol-defined Progressive Disease)
Item Group
Form completed by
CombinedInstitutionName
Item
Institution/Affiliate
text
ResponsiblePersonLastName
Item
Person Completing Form, Last Name
text
ResponsiblePersonFirstName
Item
Person Completing Form, First Name
text
ResponsiblePersonPhoneNumber
Item
Person Completing Form, Phone
text
DataAmendedInd-3
Item
Are data amended
boolean
TargetLesionDimensionInd-2
Item
Were the target lesions measured on this evaluation
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25702 (NCI Thesaurus ObjectClass-2)
C1521840 (UMLS 2011AA ObjectClass-2)
C25483 (NCI Thesaurus Property)
C0439534 (UMLS 2011AA Property)
LesionAssessmentDate
Item
Date of Evaluation
date
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C25367 (NCI Thesaurus ValueDomain-2)
Item
Response status of Target lesion (s)
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25702 (NCI Thesaurus ObjectClass-2)
C1521840 (UMLS 2011AA ObjectClass-2)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.4
Code List
Response status of Target lesion (s)
CL Item
Complete Response (Complete Response)
CL Item
Partial Response (Partial Response)
CL Item
Incomplete Response Or Stable Disease (Incomplete Response or Stable Disease)
LesionSiteNumber
Item
Lesion Number
float
C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
Item
Target Lesion Site
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25341 (NCI Thesaurus Property)
C0450429 (UMLS 2011AA Property)
C25702 (NCI Thesaurus Property-2)
C1521840 (UMLS 2011AA Property-2)
CL.5
Code List
Target Lesion Site
CL Item
Breast (Breast)
C12971 (NCI Thesaurus)
C0006141 (UMLS 2011AA)
CL Item
Axilla (Axilla)
C12674 (NCI Thesaurus)
C0004454 (UMLS 2011AA)
Longest Diameter of Lesion
Item
Longest Diameter of Lesion (s)
float
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS CUI-1)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS CUI-2)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS CUI-3)
C25209 (NCI Thesaurus ValueDomain)
C25285 (NCI Thesaurus ValueDomain-2)
LongestLesionSumDiameterMeasurement
Item
Sum of longest diameters of all target lesions (cm)
float
C25558 (NCI Thesaurus ObjectClass)
C1522425 (UMLS 2011AA ObjectClass)
C3824 (NCI Thesaurus ObjectClass-2)
C0221198 (UMLS 2011AA ObjectClass-2)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25697 (NCI Thesaurus Property-2)
C1515051 (UMLS 2011AA Property-2)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
LesionLowestSumLongestDiameterMeasurement
Item
Smallest Sum of Longest Diameters of all Target Lesions
float
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS 2011AA Property-2)
C25697 (NCI Thesaurus Property-3)
C1515051 (UMLS 2011AA Property-3)
C43517 (NCI Thesaurus Property-4)
C1708760 (UMLS 2011AA Property-4)
C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25285 (NCI Thesaurus ValueDomain-2)
C1301886 (UMLS 2011AA ValueDomain-2)
LesionLowestSumLongestDiameterDate
Item
Date Smallest Sum Observed
date
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C25558 (NCI Thesaurus Property-2)
C1522425 (UMLS 2011AA Property-2)
C25697 (NCI Thesaurus Property-3)
C1515051 (UMLS 2011AA Property-3)
C43517 (NCI Thesaurus Property-4)
C1708760 (UMLS 2011AA Property-4)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
NontargetLesionBaselinePresentInd-2
Item
Were nontarget lesions identified on the baseline evaluation
boolean
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass-2)
C1518389 (UMLS 2011AA ObjectClass-2)
C25626 (NCI Thesaurus Property)
C0150312 (UMLS 2011AA Property)
C25213 (NCI Thesaurus Property-2)
C1442488 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
NontargetLesionFollow-upAssessmentInd-2
Item
Were the nontarget lesions assessed on this evaluation
boolean
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass-2)
C1518389 (UMLS 2011AA ObjectClass-2)
C25367 (NCI Thesaurus Property)
C16033 (NCI Thesaurus Property-2)
C1522577 (UMLS 2011AA Property)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
Item
Response Status of NONTARGET Lesions
text
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25592 (NCI Thesaurus ObjectClass-2)
C1518389 (UMLS 2011AA ObjectClass-2)
C25755 (NCI Thesaurus Property)
C0871261 (UMLS 2011AA Property)
C25688 (NCI Thesaurus ValueDomain)
C0449438 (UMLS 2011AA ValueDomain)
CL.8
Code List
Response Status of NONTARGET Lesions
CL Item
Complete Response (Complete Response)
CL Item
Incomplete Response/sd (Incomplete Response/SD)
CL Item
Progressive Disease (Progressive Disease)
C35571 (NCI Thesaurus)
C1335499 (UMLS 2011AA)
NewLesionAppearanceInd-2
Item
Was the appearance of any new lesions documented
boolean
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus ObjectClass-2)
C0205314 (UMLS 2011AA ObjectClass-2)
C25377 (NCI Thesaurus Property)
C0700364 (UMLS 2011AA Property)
Item
New Lesion Site
text
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property-2)
C0450429 (UMLS 2011AA Property-2)
CL.10
Code List
New Lesion Site
CL Item
Breast (Breast)
C12971 (NCI Thesaurus)
C0006141 (UMLS 2011AA)
CL Item
Axilla (Axilla)
C12674 (NCI Thesaurus)
C0004454 (UMLS 2011AA)
CL Item
Other (Other)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus-3)
C0205394 (UMLS 2011AA-4)
LesionNewLocationSpecify
Item
Specify
text
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3824 (NCI Thesaurus ObjectClass)
C0221198 (UMLS 2011AA ObjectClass)
C25586 (NCI Thesaurus Property)
C0205314 (UMLS 2011AA Property)
C25341 (NCI Thesaurus Property-2)
C0450429 (UMLS 2011AA Property-2)
DiseaseOtherIndicationProgressionInd-2
Item
Was there any other manifestation of disease progression (other than progression of target lesions, progression of nontarget lesions, or the appearance of a new lesion)
boolean
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25331 (NCI Thesaurus Property-2)
C41184 (NCI Thesaurus Property-3)
C0392360 (UMLS 2011AA Property-2)
C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
DiseaseOtherIndicationProgressionSpecify
Item
Specify (If yes)
text
C2991 (NCI Thesaurus ObjectClass)
C0012634 (UMLS 2011AA ObjectClass)
C17649 (NCI Thesaurus Property)
C0205394 (UMLS 2011AA Property)
C25331 (NCI Thesaurus Property-2)
C41184 (NCI Thesaurus Property-3)
C0392360 (UMLS 2011AA Property-2)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
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