ID

5064

Description

ODM derived from http://clinicaltrials.gov/show/NCT00993473

Link

http://clinicaltrials.gov/show/NCT00993473

Keywords

Versions (2)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 4/17/14 4/17/14 - Julian Varghese
Uploaded on

April 17, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00993473 Type 1 Diabetes Mellitus

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age 1 Year to 6 Years
Description

age 1 Year to 6 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Pediatric patients with type 1 diabetes mellitus aged >= one year to < 6 years at screening, for whom signed written informed consent has been obtained from parent or legal guardian to participate in the study
Description

Pediatric patients with type 1 diabetes mellitus aged >= one year to < 6 years at screening, for whom signed written informed consent has been obtained from parent or legal guardian to participate in the study

Data type

boolean

Alias
UMLS CUI 2011AA
C1521725
UMLS CUI 2011AA
C0011854
SNOMED CT 2011_0131
46635009
MedDRA 14.1
10067584
LOINC Version 232
MTHU020217
ICD-10-CM Version 2010
E10
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C1519316
UMLS CUI 2011AA
C1576874
HL7 V3 2006_05
WRITTEN
UMLS CUI 2011AA
C0021430
UMLS CUI 2011AA
C1301820
SNOMED CT 2011_0131
398092000
UMLS CUI 2011AA
C0030551
SNOMED CT 2011_0131
40683002
HL7 V3 2006_05
PARNT
UMLS CUI 2011AA
C0023226
SNOMED CT 2011_0131
58626002
LOINC Version 232
MTHU020628
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Diagnosis of type 1 diabetes for < one year
Description

Diagnosis of type 1 diabetes for < one year

Data type

boolean

Alias
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0011854
SNOMED CT 2011_0131
46635009
MedDRA 14.1
10067584
LOINC Version 232
MTHU020217
ICD-10-CM Version 2010
E10
UMLS CUI 2011AA
C0439092
SNOMED CT 2011_0131
276139006
HL7 V3 2006_05
LT
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
HbA1c at screening >12% or <6%
Description

HbA1c at screening >12% or <6%

Data type

boolean

Alias
UMLS CUI 2011AA
C0019018
Diabetes other than type 1 diabetes
Description

Diabetes other than type 1 diabetes

Data type

boolean

Alias
UMLS CUI 2011AA
C0011849
SNOMED CT 2011_0131
191044006
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0011854
SNOMED CT 2011_0131
46635009
MedDRA 14.1
10067584
LOINC Version 232
MTHU020217
ICD-10-CM Version 2010
E10
Parents and patients not willing to undergo all study assessments and treatments, including home blood glucose monitoring, Continuous Glucose Monitoring System (CGMS) sensor placement and maintenance both at the site and at home, multiple daily insulin injections, and visits, as dictated by the protocol (if a telephone is not available patients may undergo all visits in person)
Description

Parents and patients not willing to undergo all study assessments and treatments, including home blood glucose monitoring, Continuous Glucose Monitoring System (CGMS) sensor placement and maintenance both at the site and at home, multiple daily insulin injections, and visits, as dictated by the protocol (if a telephone is not available patients may undergo all visits in person)

Data type

boolean

Alias
UMLS CUI 2011AA
C0558080
SNOMED CT 2011_0131
225465005
UMLS CUI 2011AA
C1321605
SNOMED CT 2011_0131
405078008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C1514873
UMLS CUI 2011AA
C1276391
SNOMED CT 2011_0131
359772000
UMLS CUI 2011AA
C0785704
SNOMED CT 2011_0131
354068006
UMLS CUI 2011AA
C0439064
SNOMED CT 2011_0131
255204007
UMLS CUI 2011AA
C0332173
SNOMED CT 2011_0131
69620002
UMLS CUI 2011AA
C0586328
SNOMED CT 2011_0131
308755006
Patients and families for whom 6 days in total (not necessarily continuous) of useable CGMS data cannot be obtained (either by home sensor replacement, or by sensor replacement at the site at additional screening visits if needed) during the screening CGMS evaluations between Visit 2 and the randomization visit
Description

Patients and families for whom 6 days in total (not necessarily continuous) of useable CGMS data cannot be obtained (either by home sensor replacement, or by sensor replacement at the site at additional screening visits if needed) during the screening CGMS evaluations between Visit 2 and the randomization visit

Data type

boolean

Alias
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C1301820
SNOMED CT 2011_0131
398092000
UMLS CUI 2011AA
C0205452
SNOMED CT 2011_0131
68244004
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0205197
SNOMED CT 2011_0131
255594003
UMLS CUI 2011AA
C0872182
UMLS CUI 2011AA
C0449913
SNOMED CT 2011_0131
246333005
LOINC Version 232
MTHU025766
UMLS CUI 2011AA
C1511726
Patients treated with insulin pump therapy during the two months prior to screening
Description

Patients treated with insulin pump therapy during the two months prior to screening

Data type

boolean

Alias
UMLS CUI 2011AA
C1140609
SNOMED CT 2011_0131
69805005
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
History of primary seizure disorder
Description

History of primary seizure disorder

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
C0852425
MedDRA 14.1
10039912
History of severe hypoglycemic episode accompanied by seizure and/or coma, or diabetic ketoacidosis leading to hospitalization or to care in the emergency ward, in the 2 months prior to the screening visit
Description

History of severe hypoglycemic episode accompanied by seizure and/or coma, or diabetic ketoacidosis leading to hospitalization or to care in the emergency ward, in the 2 months prior to the screening visit

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0020615
SNOMED CT 2011_0131
302866003
MedDRA 14.1
10020993
ICD-10-CM Version 2010
E16.2
ICD-9-CM Version 2011
251.2
CTCAE 1105E
E12322
UMLS CUI 2011AA
C0332189
SNOMED CT 2011_0131
272128006
UMLS CUI 2011AA
C0036572
SNOMED CT 2011_0131
91175000
MedDRA 14.1
10039910
ICD-9-CM Version 2011
780.39
UMLS CUI 2011AA
C0009421
SNOMED CT 2011_0131
371632003
MedDRA 14.1
10010071
LOINC Version 232
MTHU020645
ICD-10-CM Version 2010
R40.20
ICD-9-CM Version 2011
780.01
UMLS CUI 2011AA
C0011880
SNOMED CT 2011_0131
420422005
MedDRA 14.1
10012671
ICD-9-CM Version 2011
250.1
Need for chronic treatment with acetaminophen (paracetamol)-containing medications
Description

Need for chronic treatment with acetaminophen (paracetamol)-containing medications

Data type

boolean

Alias
UMLS CUI 2011AA
C0686904
SNOMED CT 2011_0131
103325001
UMLS CUI 2011AA
C0205191
SNOMED CT 2011_0131
90734009
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0000970
SNOMED CT 2011_0131
387517004
LOINC Version 232
MTHU003399
UMLS CUI 2011AA
C0332256
SNOMED CT 2011_0131
42504009
UMLS CUI 2011AA
C0013227
Serum creatinine > 2.0mg/dL at screening
Description

Serum creatinine > 2.0mg/dL at screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0201976
SNOMED CT 2011_0131
113075003
MedDRA 14.1
10040230
UMLS CUI 2011AA
C1409616
Serum ALT or AST > 3x upper limit of normal for the patient's age and gender, at screening
Description

Serum ALT or AST > 3x upper limit of normal for the patient's age and gender, at screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0001899
SNOMED CT 2011_0131
56935002
LOINC Version 232
MTHU006766
UMLS CUI 2011AA
C0004002
SNOMED CT 2011_0131
26091008
LOINC Version 232
MTHU004883
UMLS CUI 2011AA
C1519815
UMLS CUI 2011AA
C1409616
Hemoglobin < 10g/dL, or platelet count < 100,000/cu mm, at screening
Description

Hemoglobin < 10g/dL, or platelet count < 100,000/cu mm, at screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0019046
SNOMED CT 2011_0131
38082009
MedDRA 14.1
10019481
LOINC Version 232
LP14449-0
UMLS CUI 2011AA
C1287267
SNOMED CT 2011_0131
365632008
LOINC Version 232
777-3
UMLS CUI 2011AA
C1409616
Treatment with any pharmacologic anti-hyperglycemic oral agent for > 3 months at any time
Description

Treatment with any pharmacologic anti-hyperglycemic oral agent for > 3 months at any time

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0205464
SNOMED CT 2011_0131
56183000
UMLS CUI 2011AA
C0359086
SNOMED CT 2011_0131
346597008
LOINC Version 232
MTHU003326
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
Treatment with any non-insulin antihyperglycemic medication (eg, Symlin) for the 3 months prior to screening
Description

Treatment with any non-insulin antihyperglycemic medication (eg, Symlin) for the 3 months prior to screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C2825234
UMLS CUI 2011AA
C1174780
SNOMED CT 2011_0131
427360000
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
Treatment with systemic glucocorticoids within the month prior to screening
Description

Treatment with systemic glucocorticoids within the month prior to screening

Data type

boolean

Alias
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
CL428886
MedDRA 14.1
10071104
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1409616
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
CL425202 (UMLS CUI 2011AA)
age 1 Year to 6 Years
Item
age 1 Year to 6 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Pediatric patients with type 1 diabetes mellitus aged >= one year to < 6 years at screening, for whom signed written informed consent has been obtained from parent or legal guardian to participate in the study
Item
Pediatric patients with type 1 diabetes mellitus aged >= one year to < 6 years at screening, for whom signed written informed consent has been obtained from parent or legal guardian to participate in the study
boolean
C1521725 (UMLS CUI 2011AA)
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C1519316 (UMLS CUI 2011AA)
C1576874 (UMLS CUI 2011AA)
WRITTEN (HL7 V3 2006_05)
C0021430 (UMLS CUI 2011AA)
C1301820 (UMLS CUI 2011AA)
398092000 (SNOMED CT 2011_0131)
C0030551 (UMLS CUI 2011AA)
40683002 (SNOMED CT 2011_0131)
PARNT (HL7 V3 2006_05)
C0023226 (UMLS CUI 2011AA)
58626002 (SNOMED CT 2011_0131)
MTHU020628 (LOINC Version 232)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Diagnosis of type 1 diabetes for < one year
Item
Diagnosis of type 1 diabetes for < one year
boolean
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
HbA1c at screening >12% or <6%
Item
HbA1c at screening >12% or <6%
boolean
C0019018 (UMLS CUI 2011AA)
Diabetes other than type 1 diabetes
Item
Diabetes other than type 1 diabetes
boolean
C0011849 (UMLS CUI 2011AA)
191044006 (SNOMED CT 2011_0131)
CL411789 (UMLS CUI 2011AA)
C0011854 (UMLS CUI 2011AA)
46635009 (SNOMED CT 2011_0131)
10067584 (MedDRA 14.1)
MTHU020217 (LOINC Version 232)
E10 (ICD-10-CM Version 2010)
Parents and patients not willing to undergo all study assessments and treatments, including home blood glucose monitoring, Continuous Glucose Monitoring System (CGMS) sensor placement and maintenance both at the site and at home, multiple daily insulin injections, and visits, as dictated by the protocol (if a telephone is not available patients may undergo all visits in person)
Item
Parents and patients not willing to undergo all study assessments and treatments, including home blood glucose monitoring, Continuous Glucose Monitoring System (CGMS) sensor placement and maintenance both at the site and at home, multiple daily insulin injections, and visits, as dictated by the protocol (if a telephone is not available patients may undergo all visits in person)
boolean
C0558080 (UMLS CUI 2011AA)
225465005 (SNOMED CT 2011_0131)
C1321605 (UMLS CUI 2011AA)
405078008 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C1514873 (UMLS CUI 2011AA)
C1276391 (UMLS CUI 2011AA)
359772000 (SNOMED CT 2011_0131)
C0785704 (UMLS CUI 2011AA)
354068006 (SNOMED CT 2011_0131)
C0439064 (UMLS CUI 2011AA)
255204007 (SNOMED CT 2011_0131)
C0332173 (UMLS CUI 2011AA)
69620002 (SNOMED CT 2011_0131)
C0586328 (UMLS CUI 2011AA)
308755006 (SNOMED CT 2011_0131)
Patients and families for whom 6 days in total (not necessarily continuous) of useable CGMS data cannot be obtained (either by home sensor replacement, or by sensor replacement at the site at additional screening visits if needed) during the screening CGMS evaluations between Visit 2 and the randomization visit
Item
Patients and families for whom 6 days in total (not necessarily continuous) of useable CGMS data cannot be obtained (either by home sensor replacement, or by sensor replacement at the site at additional screening visits if needed) during the screening CGMS evaluations between Visit 2 and the randomization visit
boolean
C1518422 (UMLS CUI 2011AA)
C1301820 (UMLS CUI 2011AA)
398092000 (SNOMED CT 2011_0131)
C0205452 (UMLS CUI 2011AA)
68244004 (SNOMED CT 2011_0131)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0205197 (UMLS CUI 2011AA)
255594003 (SNOMED CT 2011_0131)
C0872182 (UMLS CUI 2011AA)
C0449913 (UMLS CUI 2011AA)
246333005 (SNOMED CT 2011_0131)
MTHU025766 (LOINC Version 232)
C1511726 (UMLS CUI 2011AA)
Patients treated with insulin pump therapy during the two months prior to screening
Item
Patients treated with insulin pump therapy during the two months prior to screening
boolean
C1140609 (UMLS CUI 2011AA)
69805005 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
History of primary seizure disorder
Item
History of primary seizure disorder
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
CL414904 (UMLS CUI 2011AA)
C0852425 (UMLS CUI 2011AA)
10039912 (MedDRA 14.1)
History of severe hypoglycemic episode accompanied by seizure and/or coma, or diabetic ketoacidosis leading to hospitalization or to care in the emergency ward, in the 2 months prior to the screening visit
Item
History of severe hypoglycemic episode accompanied by seizure and/or coma, or diabetic ketoacidosis leading to hospitalization or to care in the emergency ward, in the 2 months prior to the screening visit
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0020615 (UMLS CUI 2011AA)
302866003 (SNOMED CT 2011_0131)
10020993 (MedDRA 14.1)
E16.2 (ICD-10-CM Version 2010)
251.2 (ICD-9-CM Version 2011)
E12322 (CTCAE 1105E)
C0332189 (UMLS CUI 2011AA)
272128006 (SNOMED CT 2011_0131)
C0036572 (UMLS CUI 2011AA)
91175000 (SNOMED CT 2011_0131)
10039910 (MedDRA 14.1)
780.39 (ICD-9-CM Version 2011)
C0009421 (UMLS CUI 2011AA)
371632003 (SNOMED CT 2011_0131)
10010071 (MedDRA 14.1)
MTHU020645 (LOINC Version 232)
R40.20 (ICD-10-CM Version 2010)
780.01 (ICD-9-CM Version 2011)
C0011880 (UMLS CUI 2011AA)
420422005 (SNOMED CT 2011_0131)
10012671 (MedDRA 14.1)
250.1 (ICD-9-CM Version 2011)
Need for chronic treatment with acetaminophen (paracetamol)-containing medications
Item
Need for chronic treatment with acetaminophen (paracetamol)-containing medications
boolean
C0686904 (UMLS CUI 2011AA)
103325001 (SNOMED CT 2011_0131)
C0205191 (UMLS CUI 2011AA)
90734009 (SNOMED CT 2011_0131)
C0039798 (UMLS CUI 2011AA)
C0000970 (UMLS CUI 2011AA)
387517004 (SNOMED CT 2011_0131)
MTHU003399 (LOINC Version 232)
C0332256 (UMLS CUI 2011AA)
42504009 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
Serum creatinine > 2.0mg/dL at screening
Item
Serum creatinine > 2.0mg/dL at screening
boolean
C0201976 (UMLS CUI 2011AA)
113075003 (SNOMED CT 2011_0131)
10040230 (MedDRA 14.1)
C1409616 (UMLS CUI 2011AA)
Serum ALT or AST > 3x upper limit of normal for the patient's age and gender, at screening
Item
Serum ALT or AST > 3x upper limit of normal for the patient's age and gender, at screening
boolean
C0001899 (UMLS CUI 2011AA)
56935002 (SNOMED CT 2011_0131)
MTHU006766 (LOINC Version 232)
C0004002 (UMLS CUI 2011AA)
26091008 (SNOMED CT 2011_0131)
MTHU004883 (LOINC Version 232)
C1519815 (UMLS CUI 2011AA)
C1409616 (UMLS CUI 2011AA)
Hemoglobin < 10g/dL, or platelet count < 100,000/cu mm, at screening
Item
Hemoglobin < 10g/dL, or platelet count < 100,000/cu mm, at screening
boolean
C0019046 (UMLS CUI 2011AA)
38082009 (SNOMED CT 2011_0131)
10019481 (MedDRA 14.1)
LP14449-0 (LOINC Version 232)
C1287267 (UMLS CUI 2011AA)
365632008 (SNOMED CT 2011_0131)
777-3 (LOINC Version 232)
C1409616 (UMLS CUI 2011AA)
Treatment with any pharmacologic anti-hyperglycemic oral agent for > 3 months at any time
Item
Treatment with any pharmacologic anti-hyperglycemic oral agent for > 3 months at any time
boolean
C0039798 (UMLS CUI 2011AA)
C0205464 (UMLS CUI 2011AA)
56183000 (SNOMED CT 2011_0131)
C0359086 (UMLS CUI 2011AA)
346597008 (SNOMED CT 2011_0131)
MTHU003326 (LOINC Version 232)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
Treatment with any non-insulin antihyperglycemic medication (eg, Symlin) for the 3 months prior to screening
Item
Treatment with any non-insulin antihyperglycemic medication (eg, Symlin) for the 3 months prior to screening
boolean
C0039798 (UMLS CUI 2011AA)
C2825234 (UMLS CUI 2011AA)
C1174780 (UMLS CUI 2011AA)
427360000 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
Treatment with systemic glucocorticoids within the month prior to screening
Item
Treatment with systemic glucocorticoids within the month prior to screening
boolean
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
CL428886 (UMLS CUI 2011AA)
10071104 (MedDRA 14.1)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
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