ID

6307

Beschreibung

CALGB: 140503 Surgical Resection Form Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=218D55B1-930A-6505-E044-0003BA3F9857

Link

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=218D55B1-930A-6505-E044-0003BA3F9857

Stichworte

18.12.14 18.12.14 - Martin Dugas
09.01.15 09.01.15 - Martin Dugas
21.06.15 21.06.15 -

Hochgeladen am

18. Dezember 2014

DOI

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Lung Cancer NCT00499330 Treatment - CALGB: 140503 Surgical Resection Form - 2538137v1.0

Modell
Details

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted.

1 Formulare

StudyEvent: CALGB: 140503 Surgical Resection Form
1. INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted.

Name

Typ

Description | Question | Decode (Coded Value)

Datentyp

Alias

Unnamed1

Item Group

Unnamed1

CALGBFormIdentifierNumber

Item

CALGB Form

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus ObjectClass)
C1516238 (UMLS 2011AA ObjectClass)

ProtocolCALGBIdentifierNumber

Item

CALGB Study No

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)

PatientCALGBIdentifierNumber

Item

CALGB Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25442 (NCI Thesaurus Property)
C1516238 (UMLS 2011AA Property)

DataAmendedInd-3

Item

Are data amended

text

C38148 (NCI Thesaurus ValueDomain)
C1512699 (UMLS 2011AA ValueDomain)
C25474 (NCI Thesaurus ObjectClass)
C1511726 (UMLS 2011AA ObjectClass)
C25416 (NCI Thesaurus Property)
C1691222 (UMLS 2011AA Property)

CL.1

Code List

Are data amended

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)
C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

Unnamed2

Item Group

Unnamed2

PatientInitialsName

Item

Patient Initials (Last, First Middle)

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25536 (NCI Thesaurus Property)
C1555582 (UMLS 2011AA Property)

PatientMedicalRecordNumber

Item

Patient Hospital No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25261 (NCI Thesaurus Property)
C0205476 (UMLS 2011AA Property)
C25198 (NCI Thesaurus Property)
C0034869 (UMLS 2011AA Property)

CombinedInstitutionName

Item

Institution/Affiliate

text

C25454 (NCI Thesaurus ObjectClass)
C0205195 (UMLS 2011AA ObjectClass)
C21541 (NCI Thesaurus ObjectClass)
C0018704 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)
C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C21541 (NCI Thesaurus ValueDomain)
C0018704 (UMLS 2011AA ValueDomain)

ParticipatingGroupName

Item

Participating Group

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25608 (NCI Thesaurus ObjectClass)
C0679823 (UMLS 2011AA ObjectClass)
C17005 (NCI Thesaurus ObjectClass)
C1257890 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

ProtocolParticipatingIdentifierNumber

Item

Participating Group Study No.

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C25320 (NCI Thesaurus ObjectClass)
C1507394 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

PatientParticipatingIdentifierNumber

Item

Participating Group Patient ID

text

C25337 (NCI Thesaurus ValueDomain)
C0237753 (UMLS 2011AA ValueDomain)
C16960 (NCI Thesaurus ObjectClass)
C0030705 (UMLS 2011AA ObjectClass)
C25608 (NCI Thesaurus Property)
C0679823 (UMLS 2011AA Property)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

Operative Data

Item Group

Unnamed 3

LungSurgicalProcedurePerformedType

Item

Surgical Procedure Type (Post-Operative Data)

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)

CL.2

Code List

Surgical Procedure Type (Post-Operative Data)

CL Item

Lobectomy (Lobectomy)

C15272 (NCI Thesaurus)
C0023928 (UMLS 2011AA)

CL Item

Wedge Resection (Wedge resection)

CL Item

Segmentectomy (Segmentectomy)

CL Item

Incomplete/failed Resection (Incomplete/failed resection)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

LungSurgicalProcedurePerformedSpecify

Item

Other, specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C38000 (NCI Thesaurus Property)
C0884358 (UMLS 2011AA Property)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)

LungIncompleteSurgicalProcedureReasonType

Item

Specify reason

text

C49160 (NCI Thesaurus ObjectClass)
C0205257 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25638 (NCI Thesaurus Property)
C0392360 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.3

Code List

Specify reason

CL Item

Positive Lymph Node (Positive Lymph Node)

C27296 (NCI Thesaurus)
C0746319 (UMLS 2011AA)

CL Item

Positive Margins On Permanent Sections (Positive margins on permanent sections)

CL Item

Other (Other)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

LungIncompleteSurgicalProcedureReasonSpecify

Item

Specify

text

C49160 (NCI Thesaurus ObjectClass)
C0205257 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25638 (NCI Thesaurus Property)
C0392360 (UMLS 2011AA Property)
C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)

LungSurgicalProcedureAdministeredType

Item

Surgical Approach

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C15329 (NCI Thesaurus ObjectClass)
C0543467 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)

CL.4

Code List

Surgical Approach

CL Item

Thoracotomy (thoracotomy)

CL Item

Thoracoscopy / Video-assisted (vats) (Thoracoscopy / Video-assisted (VATS))

CL Item

Thoracoscopy / Video-assisted (vats), With Conversion To Thoracotomy (Thoracoscopy / Video-assisted (VATS), with conversion to Thoracotomy)

SurgeonVideo-AssistThoracicSurgeryCertificationInd-2

Item

Is the surgeon VATS credentialed (If VATS,)

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C18071 (NCI Thesaurus ObjectClass)
C0582175 (UMLS 2011AA ObjectClass)
C43610 (NCI Thesaurus Property)
C0007836 (UMLS 2011AA Property)
C0752151 (NCI Metathesaurus Property)

CL.5

Code List

Is the surgeon VATS credentialed (If VATS,)

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

SurgicalMarginDistanceMeasurement

Item

Surgical Margin Distance (as determined by surgeon)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25698 (NCI Thesaurus ObjectClass)
C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)
C25167 (NCI Thesaurus Property)
C0012751 (UMLS 2011AA Property)

SurgicalMarginNotEvaluationText

Item

Is surgical margin not available, mark with an X

text

C25704 (NCI Thesaurus ValueDomain)
C1527021 (UMLS 2011AA ValueDomain)
C25214 (NCI Thesaurus Property)
C0220825 (UMLS 2011AA Property)
C25594 (NCI Thesaurus Property)
C1518422 (UMLS 2011AA Property)
C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)

SurgicalMarginFrozenSectionPositiveFindingInd-2

Item

If frozen section, does the tumor involve the surgical margin

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38758 (NCI Thesaurus Property)
C1514241 (UMLS 2011AA Property)
C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)
C67462 (NCI Thesaurus Property)
C0016741 (UMLS 2011AA Property)

CL.6

Code List

If frozen section, does the tumor involve the surgical margin

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PermanentSectionSurgicalMarginPositiveFindingInd-2

Item

If permanent section, does the tumor involve the surgical margin

text

C38147 (NCI Thesaurus ValueDomain)
C1512698 (UMLS 2011AA ValueDomain)
C38758 (NCI Thesaurus Property)
C1514241 (UMLS 2011AA Property)
C41227 (NCI Thesaurus ObjectClass)
C0229985 (UMLS 2011AA ObjectClass)
C67463 (NCI Thesaurus ObjectClass)
C1882347 (UMLS 2011AA ObjectClass)

CL.8

Code List

If permanent section, does the tumor involve the surgical margin

CL Item

No (No)

C49487 (NCI Thesaurus)
C1298908 (UMLS 2011AA)

CL Item

Yes (Yes)

C49488 (NCI Thesaurus)
C1705108 (UMLS 2011AA)

PositiveSurgicalMarginTherapyAdministeredType

Item

Specify treatment

text

C25246 (NCI Thesaurus ObjectClass)
C1446409 (UMLS 2011AA ObjectClass)
C25698 (NCI Thesaurus ObjectClass)
C15368 (NCI Thesaurus ObjectClass)
C25563 (NCI Thesaurus ObjectClass)
C0205284 (UMLS 2011AA ObjectClass)
C25382 (NCI Thesaurus Property)
C1521801 (UMLS 2011AA Property)
C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)

CL.9

Code List

Specify treatment

CL Item

Anatomic Segmentectomy (Anatomic segmentectomy)

CL Item

No Treatment (No treatment)

CL Item

Off-study Lobectomy (Off-study lobectomy)

CL Item

Re-wedge (Re-wedge)

PositiveSurgicalMarginTherapyAdministeredType

Item

Specify treatment

text

CL.9

Code List

Specify treatment

CL Item

Anatomic Segmentectomy (Anatomic segmentectomy)

CL Item

No Treatment (No treatment)

CL Item

Off-study Lobectomy (Off-study lobectomy)

CL Item

Re-wedge (Re-wedge)

MediastinalLymphNodePhysicalExaminationType

Item

Type of Mediastinal Lymph Node Dissection

text

C25284 (NCI Thesaurus ValueDomain)
C0332307 (UMLS 2011AA ValueDomain)
C20989 (NCI Thesaurus Property)
C0031809 (UMLS 2011AA Property)
C12745 (NCI Thesaurus ObjectClass)
C0024204 (UMLS 2011AA ObjectClass)
C25310 (NCI Thesaurus ObjectClass)
C1522718 (UMLS 2011AA ObjectClass)

CL.10

Code List

Type of Mediastinal Lymph Node Dissection

CL Item

Complete Mediastinal Lymph Node Dissection (Complete mediastinal lymph node dissection)

CL Item

Systematic Sampling (Systematic sampling)

CL Item

Simple Sampling (Simple sampling)

CL Item

None (None)

C41132 (NCI Thesaurus)
C0549184 (UMLS 2011AA)

LungTumorHistologicClassificationLungTumorHistologicCategory

Item

Histology

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)
C25372 (NCI Thesaurus ValueDomain)
C0683312 (UMLS 2011AA ValueDomain)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)

CL.11

Code List

Histology

CL Item

Adenocarcinoma (Adenocarcinoma)

C2852 (NCI Thesaurus)
C0001418 (UMLS 2011AA)

CL Item

Small Cell Carcinoma (oat Cell) (Small cell carcinoma (oat cell))

CL Item

Benign Mass (Benign mass)

CL Item

Carcinoid (Carcinoid)

CL Item

Unknown (Unknown)

C17998 (NCI Thesaurus)
C0439673 (UMLS 2011AA)

CL Item

Other (Other specify)

C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)
C17649 (NCI Thesaurus)
C0205394 (UMLS 2011AA)

TumorHistologicCategorySpecify

Item

Other specify

text

C25685 (NCI Thesaurus ValueDomain)
C1521902 (UMLS 2011AA ValueDomain)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25161 (NCI Thesaurus Property)
C0008902 (UMLS 2011AA Property)

LungTumorHistologicGrade

Item

Histologic Grade (Differentiation)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25526 (NCI Thesaurus Property)
C0205462 (UMLS 2011AA Property)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)
C25526 (NCI Thesaurus ValueDomain)
C0205462 (UMLS 2011AA ValueDomain)
C18000 (NCI Thesaurus ValueDomain)
C0919553 (UMLS 2011AA ValueDomain)

CL.12

Code List

Histologic Grade (Differentiation)

CL Item

Well Differentiated (Grade I)

C14171 (NCI Thesaurus)
C0205615 (UMLS 2011AA)

CL Item

Moderately Differentiated (Grade II)

C14162 (NCI Thesaurus)
C0205616 (UMLS 2011AA)

CL Item

Poorly Differentiated (Grade III)

C14167 (NCI Thesaurus)
C0205617 (UMLS 2011AA)

CL Item

Undifferentiated (Grade IV)

C14176 (NCI Thesaurus)
C0205618 (UMLS 2011AA)

TumorMaximumDiameterMeasurement

Item

Maximum Diameter (cm)

double

C25209 (NCI Thesaurus ValueDomain)
C0242485 (UMLS 2011AA ValueDomain)
C25285 (NCI Thesaurus Property)
C1301886 (UMLS 2011AA Property)
C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C25564 (NCI Thesaurus Property)
C0806909 (UMLS 2011AA Property)

Pathologic T-N-M Staging

Item Group

Lung: Surgical-pathological Results

LungTumorPathologicTStage

Item

Pathologic T Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)
C25365 (NCI Thesaurus Property)
C0678257 (UMLS 2011AA Property)

CL.13

Code List

Pathologic T Stage

CL Item

Primary Tumor Cannot Be Assessed, Or Tumor Proven By The Presence Of Malignant Cells In Sputum Or Bronchial Washings But Not Visualized By Imaging Or Bronchoscopy (TX)

CL Item

No Evidence Of Primary Tumor (T0)

CL Item

Carcinoma In Situ (Tis)

C2917 (NCI Thesaurus)
C0007099 (UMLS 2011AA)
C2917 (NCI Thesaurus)
C0007099 (UMLS 2011AA)

CL Item

Tumor 3 Cm Or Less In Greatest Dimension, Surrounded By Lung Or Visceral Pleura, Invasion More Proximal Than The Lobar Bronchus, (i.e., Not In The Main Bronchus) (T1)

CL Item

Tumor With Any Of The Following Features Of Size Or Extent: More Than 3cm In Greatest Dimension; Invades The Visceral Pleura; Associated With Atelectasis Or Obstructive Pneumonitis That Extends To The Hilar Region But Does Not Involve The Entire Lung (T2)

CL Item

Tumor Of Any Size That Directly Invades Any Of The Following: Chest Wall (including Superior Sulcus Tumors), Diaphragm, Mediastinal Pleura, Parietal Pericardium; Or Tumor In The Main Bronchus Less Than 2 Cm Distal To The Carina, But Without Involvement O* (T3)

CL Item

Tumor Of Any Size That Invades Any Of The Following: Mediastinum, Heart, Great Vessels, Trachea, Esophagus, Vertebral Body, Carina; Or Separate Tumor Nodules In The Same Lobe; Or Tumor With A Malignant Pleural Effusion (T4)

LungTumorPathologicNStage

Item

Pathologic N Stage

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25610 (NCI Thesaurus Property)
C1521733 (UMLS 2011AA Property)
C25580 (NCI Thesaurus Property)
C0456532 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.14

Code List

Pathologic N Stage

CL Item

No Regional Lymph Node Metastasis (N0)

CL Item

Metastasis To Ipsilateral Peribronchial And/or Ipsilateral Hilar Lymph Nodes, And Intrapulmonary Nodes Including Involvement By Direct Extension Of The Primary Tumor (N1)

CL Item

Metastasis To Ipsilateral Mediastinal And/or Subcarinal Lymph Node(s) (N2)

CL Item

Metastasis To Contralateral Mediastinal, Contralateral Hilar, Ipsilateral Or Contralateral Scalene, Or Supraclavicular Lymph Node(s) (N3)

CL Item

Regional Lymph Nodes Cannot Be Assessed (NX)

LungTumorClinicalMStage

Item

Clinical M Stage ([M] Mark one with an X.)

text

C3262 (NCI Thesaurus ObjectClass)
C0027651 (UMLS 2011AA ObjectClass)
C12468 (NCI Thesaurus ObjectClass)
C0024109 (UMLS 2011AA ObjectClass)
C25398 (NCI Thesaurus Property)
C0205210 (UMLS 2011AA Property)
C25727 (NCI Thesaurus Property)
C0456533 (UMLS 2011AA Property)
C16899 (NCI Thesaurus ValueDomain)
C1300072 (UMLS 2011AA ValueDomain)

CL.15

Code List

Clinical M Stage ([M] Mark one with an X.)

CL Item

No Distant Metastasis (M0)

CL Item

Distant Metastasis Present (M1)

CL Item

Distant Metastasis Cannot Be Assessed (MX)

Footer Module

Item Group

Surgical Complications And Morbidities

ResponsiblePersonName

Item

Completed by

text

C25191 (NCI Thesaurus ValueDomain)
C1547383 (UMLS 2011AA ValueDomain)
C25657 (NCI Thesaurus ObjectClass)
C1273518 (UMLS 2011AA ObjectClass)
C25364 (NCI Thesaurus Property)
C0600091 (UMLS 2011AA Property)

FormOriginalCompleteDate

Item

Date Form Originally Completed

date

C19464 (NCI Thesaurus ObjectClass)
C0376315 (UMLS 2011AA ObjectClass)
C25250 (NCI Thesaurus Property)
C0205197 (UMLS 2011AA Property)
C25604 (NCI Thesaurus Property)
C0205313 (UMLS 2011AA Property)
C25164 (NCI Thesaurus ValueDomain)
C0011008 (UMLS 2011AA ValueDomain)
C25367 (NCI Thesaurus ValueDomain)

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Lung Cancer NCT00499330 Treatment - CALGB: 140503 Surgical Resection Form - 2538137v1.0

INSTRUCTIONS: Complete and submit this form as required by the protocol. Information in the upper right box must be completed for this form to be accepted.

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