ID

32660

Beschreibung

Patient Preference of h-Patch vs. Pen or Needle/Syringe as Insulin Administration Device; ODM derived from: https://clinicaltrials.gov/show/NCT00453934

Link

https://clinicaltrials.gov/show/NCT00453934

Stichworte

Versionen (1)
  1. 10.11.18 10.11.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

10. November 2018

DOI

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Lizenz

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Eligibility Type 1 Diabetes NCT00453934

Englisch

Eligibility Type 1 Diabetes NCT00453934

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. diagnosis of type 1or type 2 diabetes mellitus for at least a year
Beschreibung

Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0011860
UMLS CUI [2,2]
C0872146
2. stable insulin regimen for at least 3 months consisting of multiple daily injections of human regular or rapid acting insulin at meal times and long or intermediate acting insulin as basal. in this protocol multiple daily injections requires at least three injections daily.
Beschreibung

Insulin regime Stable | Injection Multiple Daily | Regular Insulin, Human | Short-Acting Insulin Mealtimes | Insulin, Long-Acting | Intermediate-acting insulin | Basal insulin

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0557978
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C1533685
UMLS CUI [2,2]
C0439064
UMLS CUI [2,3]
C0332173
UMLS CUI [3]
C0795635
UMLS CUI [4,1]
C0356365
UMLS CUI [4,2]
C0587119
UMLS CUI [5]
C0304870
UMLS CUI [6]
C0304869
UMLS CUI [7]
C0650607
3. total daily insulin dose between 50 and 80 units.
Beschreibung

Insulin Total Dose U/day

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021641
UMLS CUI [1,2]
C2986497
UMLS CUI [1,3]
C0456683
4. if patient is type 2, can be treated with metformin and/or a thiazolidinedione and/or a sulfonylurea, but other diabetes drugs including α-glucosidase inhibitors, meglitinides, pramlintide exenatide, and dpp-iv's are excluded.
Beschreibung

Diabetes Mellitus, Non-Insulin-Dependent | Metformin | Thiazolidinediones | Sulfonylureas | alpha-Glucosidase Inhibitors Excluded | Meglitinide Excluded | Pramlintide Excluded | Exenatide Excluded | Dipeptidyl-Peptidase IV Inhibitors Excluded

Datentyp

boolean

Alias
UMLS CUI [1]
C0011860
UMLS CUI [2]
C0025598
UMLS CUI [3]
C1257987
UMLS CUI [4]
C0038766
UMLS CUI [5,1]
C1299007
UMLS CUI [5,2]
C0332196
UMLS CUI [6,1]
C0065880
UMLS CUI [6,2]
C0332196
UMLS CUI [7,1]
C0537551
UMLS CUI [7,2]
C0332196
UMLS CUI [8,1]
C0167117
UMLS CUI [8,2]
C0332196
UMLS CUI [9,1]
C1827106
UMLS CUI [9,2]
C0332196
5. hba1c > 7.0% and < 9.0%.
Beschreibung

Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474680
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. recurrent major hypoglycemia or prolonged unstable blood glucose control (as judged by the investigator).
Beschreibung

Hypoglycemia Major | Blood Glucose Control Unstable Prolonged

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020615
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0005802
UMLS CUI [2,2]
C2587213
UMLS CUI [2,3]
C0443343
UMLS CUI [2,4]
C0439590
2. use of other diabetes drugs including α-glucosidase inhibitors, meglitinides, pramlintide, exenatide or dpp-iv inhibitors (metformin and/or a thiazolidinedione and/or a sulfonylurea are allowed).
Beschreibung

Antidiabetics | alpha-Glucosidase Inhibitors | Meglitinide | Pramlintide | exenatide | Dipeptidyl-Peptidase IV Inhibitors | Metformin allowed | Thiazolidinediones allowed | Sulfonylureas allowed

Datentyp

boolean

Alias
UMLS CUI [1]
C0935929
UMLS CUI [2]
C1299007
UMLS CUI [3]
C0065880
UMLS CUI [4]
C0537551
UMLS CUI [5]
C0167117
UMLS CUI [6]
C1827106
UMLS CUI [7,1]
C0025598
UMLS CUI [7,2]
C0683607
UMLS CUI [8,1]
C1257987
UMLS CUI [8,2]
C0683607
UMLS CUI [9,1]
C0038766
UMLS CUI [9,2]
C0683607
3. intend to use any other concomitant drug therapy (prescription or over-the-counter medications) that can affect blood glucose levels.
Beschreibung

Pharmacotherapy Affecting Blood glucose level | Non-Prescription Drugs Affecting Blood glucose level

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0428554
UMLS CUI [2,1]
C0013231
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0428554
4. have used systemic glucocorticoids within 1 month prior to screening or currently on glucocorticoids.
Beschreibung

Glucocorticoids, Systemic | Glucocorticoids

Datentyp

boolean

Alias
UMLS CUI [1]
C3540777
UMLS CUI [2]
C0017710
5. have a history of drug or alcohol abuse within 1 year prior to screening visit.
Beschreibung

Substance Use Disorders

Datentyp

boolean

Alias
UMLS CUI [1]
C0038586
6. have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, or neurological disease that would, in the investigator's opinion, preclude safe participation in the study.
Beschreibung

Cardiovascular Disease Study Subject Participation Status Excluded | Respiration Disorder Study Subject Participation Status Excluded | Liver disease Study Subject Participation Status Excluded | Kidney Disease Study Subject Participation Status Excluded | Gastrointestinal Disease Study Subject Participation Status Excluded | Nervous system disorder Study Subject Participation Status Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0035204
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0332196
UMLS CUI [4,1]
C0022658
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C0332196
UMLS CUI [5,1]
C0017178
UMLS CUI [5,2]
C2348568
UMLS CUI [5,3]
C0332196
UMLS CUI [6,1]
C0027765
UMLS CUI [6,2]
C2348568
UMLS CUI [6,3]
C0332196
7. have a history of major surgery, e.g. laparotomy, thoracotomy, open orthopedic procedure, etc. within 3 months prior to screening visit.
Beschreibung

Major surgery | Laparotomy | Thoracotomy | Orthopedic Procedure Open

Datentyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0023038
UMLS CUI [3]
C0039991
UMLS CUI [4,1]
C0524852
UMLS CUI [4,2]
C0175566
8. evidence of significant neuropsychiatric disease.
Beschreibung

Neuropsychiatric syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C3203509
9. have participated in a medical, surgical, or pharmaceutical investigational new drug/device study in the last 30 days or ≤ 5 half-lives of the investigational drug, whichever is longer, prior to screening visit.
Beschreibung

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Clinical Trial | Clinical Trial Surgical | Pharmaceutical Preparations Investigational

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4]
C0008976
UMLS CUI [5,1]
C0008976
UMLS CUI [5,2]
C0543467
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C1517586
10. blood donation of 500 ml or more in the last 2 months prior to screening visit.
Beschreibung

Blood Donation Amount

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1265611
11. evidence of significant active hematological disease.
Beschreibung

Hematological Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0018939
12. acute infection with fever.
Beschreibung

Communicable Disease With Fever

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332287
UMLS CUI [1,3]
C0015967
13. hemoglobin < 10 g/dl; ast, alt ≥ 1.5 times the upper reference limit at screening.
Beschreibung

Hemoglobin measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased

Datentyp

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0151905
14. uncontrolled treated/untreated hypertension (systolic blood pressure > 155 mmhg and diastolic blood pressure > 90 mmhg).
Beschreibung

Uncontrolled hypertension Treated | Uncontrolled hypertension Untreated | Systolic Pressure | Diastolic blood pressure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1868885
UMLS CUI [1,2]
C1522326
UMLS CUI [2,1]
C1868885
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
15. history of proliferative retinopathy or maculopathy requiring acute treatment
Beschreibung

Proliferative retinopathy | Disorder of macula of retina Treatment required for

Datentyp

boolean

Alias
UMLS CUI [1]
C0339467
UMLS CUI [2,1]
C0730362
UMLS CUI [2,2]
C0332121
16. mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation.
Beschreibung

Mental handicap Preventing Comprehension | Comprehension Unwilling | Language Barrier Preventing Comprehension | Mental handicap Preventing Cooperation | Cooperation Unwilling | Language Barrier Preventing Cooperation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1306341
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0162340
UMLS CUI [2,1]
C0162340
UMLS CUI [2,2]
C0558080
UMLS CUI [3,1]
C0237167
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0162340
UMLS CUI [4,1]
C1306341
UMLS CUI [4,2]
C1292733
UMLS CUI [4,3]
C0392337
UMLS CUI [5,1]
C0392337
UMLS CUI [5,2]
C0558080
UMLS CUI [6,1]
C0237167
UMLS CUI [6,2]
C1292733
UMLS CUI [6,3]
C0392337
17. any condition that the investigator and/or sponsor feel would interfere with trial participation or evaluation of results
Beschreibung

Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C1261322
UMLS CUI [2,4]
C0683954
18. pregnancy, breast-feeding, intention of becoming pregnant for female patients of child-bearing potential.
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Planned Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0032992
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Ähnliche Modelle

Eligibility Type 1 Diabetes NCT00453934

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Insulin-Dependent Diabetes Mellitus Disease length | Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
1. diagnosis of type 1or type 2 diabetes mellitus for at least a year
boolean
C0011854 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0011860 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
Insulin regime Stable | Injection Multiple Daily | Regular Insulin, Human | Short-Acting Insulin Mealtimes | Insulin, Long-Acting | Intermediate-acting insulin | Basal insulin
Item
2. stable insulin regimen for at least 3 months consisting of multiple daily injections of human regular or rapid acting insulin at meal times and long or intermediate acting insulin as basal. in this protocol multiple daily injections requires at least three injections daily.
boolean
C0557978 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C1533685 (UMLS CUI [2,1])
C0439064 (UMLS CUI [2,2])
C0332173 (UMLS CUI [2,3])
C0795635 (UMLS CUI [3])
C0356365 (UMLS CUI [4,1])
C0587119 (UMLS CUI [4,2])
C0304870 (UMLS CUI [5])
C0304869 (UMLS CUI [6])
C0650607 (UMLS CUI [7])
Insulin Total Dose U/day
Item
3. total daily insulin dose between 50 and 80 units.
boolean
C0021641 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
Diabetes Mellitus, Non-Insulin-Dependent | Metformin | Thiazolidinediones | Sulfonylureas | alpha-Glucosidase Inhibitors Excluded | Meglitinide Excluded | Pramlintide Excluded | Exenatide Excluded | Dipeptidyl-Peptidase IV Inhibitors Excluded
Item
4. if patient is type 2, can be treated with metformin and/or a thiazolidinedione and/or a sulfonylurea, but other diabetes drugs including α-glucosidase inhibitors, meglitinides, pramlintide exenatide, and dpp-iv's are excluded.
boolean
C0011860 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
C0038766 (UMLS CUI [4])
C1299007 (UMLS CUI [5,1])
C0332196 (UMLS CUI [5,2])
C0065880 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C0537551 (UMLS CUI [7,1])
C0332196 (UMLS CUI [7,2])
C0167117 (UMLS CUI [8,1])
C0332196 (UMLS CUI [8,2])
C1827106 (UMLS CUI [9,1])
C0332196 (UMLS CUI [9,2])
Hemoglobin A1c measurement
Item
5. hba1c > 7.0% and < 9.0%.
boolean
C0474680 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypoglycemia Major | Blood Glucose Control Unstable Prolonged
Item
1. recurrent major hypoglycemia or prolonged unstable blood glucose control (as judged by the investigator).
boolean
C0020615 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0005802 (UMLS CUI [2,1])
C2587213 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
C0439590 (UMLS CUI [2,4])
Antidiabetics | alpha-Glucosidase Inhibitors | Meglitinide | Pramlintide | exenatide | Dipeptidyl-Peptidase IV Inhibitors | Metformin allowed | Thiazolidinediones allowed | Sulfonylureas allowed
Item
2. use of other diabetes drugs including α-glucosidase inhibitors, meglitinides, pramlintide, exenatide or dpp-iv inhibitors (metformin and/or a thiazolidinedione and/or a sulfonylurea are allowed).
boolean
C0935929 (UMLS CUI [1])
C1299007 (UMLS CUI [2])
C0065880 (UMLS CUI [3])
C0537551 (UMLS CUI [4])
C0167117 (UMLS CUI [5])
C1827106 (UMLS CUI [6])
C0025598 (UMLS CUI [7,1])
C0683607 (UMLS CUI [7,2])
C1257987 (UMLS CUI [8,1])
C0683607 (UMLS CUI [8,2])
C0038766 (UMLS CUI [9,1])
C0683607 (UMLS CUI [9,2])
Pharmacotherapy Affecting Blood glucose level | Non-Prescription Drugs Affecting Blood glucose level
Item
3. intend to use any other concomitant drug therapy (prescription or over-the-counter medications) that can affect blood glucose levels.
boolean
C0013216 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0428554 (UMLS CUI [1,3])
C0013231 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0428554 (UMLS CUI [2,3])
Glucocorticoids, Systemic | Glucocorticoids
Item
4. have used systemic glucocorticoids within 1 month prior to screening or currently on glucocorticoids.
boolean
C3540777 (UMLS CUI [1])
C0017710 (UMLS CUI [2])
Substance Use Disorders
Item
5. have a history of drug or alcohol abuse within 1 year prior to screening visit.
boolean
C0038586 (UMLS CUI [1])
Cardiovascular Disease Study Subject Participation Status Excluded | Respiration Disorder Study Subject Participation Status Excluded | Liver disease Study Subject Participation Status Excluded | Kidney Disease Study Subject Participation Status Excluded | Gastrointestinal Disease Study Subject Participation Status Excluded | Nervous system disorder Study Subject Participation Status Excluded
Item
6. have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, or neurological disease that would, in the investigator's opinion, preclude safe participation in the study.
boolean
C0007222 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0035204 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0023895 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
C0022658 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C0332196 (UMLS CUI [4,3])
C0017178 (UMLS CUI [5,1])
C2348568 (UMLS CUI [5,2])
C0332196 (UMLS CUI [5,3])
C0027765 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C0332196 (UMLS CUI [6,3])
Major surgery | Laparotomy | Thoracotomy | Orthopedic Procedure Open
Item
7. have a history of major surgery, e.g. laparotomy, thoracotomy, open orthopedic procedure, etc. within 3 months prior to screening visit.
boolean
C0679637 (UMLS CUI [1])
C0023038 (UMLS CUI [2])
C0039991 (UMLS CUI [3])
C0524852 (UMLS CUI [4,1])
C0175566 (UMLS CUI [4,2])
Neuropsychiatric syndrome
Item
8. evidence of significant neuropsychiatric disease.
boolean
C3203509 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device | Clinical Trial | Clinical Trial Surgical | Pharmaceutical Preparations Investigational
Item
9. have participated in a medical, surgical, or pharmaceutical investigational new drug/device study in the last 30 days or ≤ 5 half-lives of the investigational drug, whichever is longer, prior to screening visit.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C0008976 (UMLS CUI [4])
C0008976 (UMLS CUI [5,1])
C0543467 (UMLS CUI [5,2])
C0013227 (UMLS CUI [6,1])
C1517586 (UMLS CUI [6,2])
Blood Donation Amount
Item
10. blood donation of 500 ml or more in the last 2 months prior to screening visit.
boolean
C0005794 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Hematological Disease
Item
11. evidence of significant active hematological disease.
boolean
C0018939 (UMLS CUI [1])
Communicable Disease With Fever
Item
12. acute infection with fever.
boolean
C0009450 (UMLS CUI [1,1])
C0332287 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
Hemoglobin measurement | Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
13. hemoglobin < 10 g/dl; ast, alt ≥ 1.5 times the upper reference limit at screening.
boolean
C0518015 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0151905 (UMLS CUI [3])
Uncontrolled hypertension Treated | Uncontrolled hypertension Untreated | Systolic Pressure | Diastolic blood pressure
Item
14. uncontrolled treated/untreated hypertension (systolic blood pressure > 155 mmhg and diastolic blood pressure > 90 mmhg).
boolean
C1868885 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C1868885 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Proliferative retinopathy | Disorder of macula of retina Treatment required for
Item
15. history of proliferative retinopathy or maculopathy requiring acute treatment
boolean
C0339467 (UMLS CUI [1])
C0730362 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
Mental handicap Preventing Comprehension | Comprehension Unwilling | Language Barrier Preventing Comprehension | Mental handicap Preventing Cooperation | Cooperation Unwilling | Language Barrier Preventing Cooperation
Item
16. mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation.
boolean
C1306341 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C0162340 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
C0237167 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0162340 (UMLS CUI [3,3])
C1306341 (UMLS CUI [4,1])
C1292733 (UMLS CUI [4,2])
C0392337 (UMLS CUI [4,3])
C0392337 (UMLS CUI [5,1])
C0558080 (UMLS CUI [5,2])
C0237167 (UMLS CUI [6,1])
C1292733 (UMLS CUI [6,2])
C0392337 (UMLS CUI [6,3])
Condition Interferes with Study Subject Participation Status | Condition Interferes with Evaluation Research results
Item
17. any condition that the investigator and/or sponsor feel would interfere with trial participation or evaluation of results
boolean
C0348080 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
Pregnancy | Breast Feeding | Childbearing Potential Planned Pregnancy
Item
18. pregnancy, breast-feeding, intention of becoming pregnant for female patients of child-bearing potential.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0032992 (UMLS CUI [3,2])
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