ID

33032

Beschrijving

Health Benefits of Aerobic and Resistance Training in Individuals With Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00458133

Link

https://clinicaltrials.gov/show/NCT00458133

Trefwoorden

Versies (1)
  1. 23-11-18 23-11-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 november 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Type 2 Diabetes NCT00458133

Engels

Eligibility Type 2 Diabetes NCT00458133

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
age 30-75 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
type 2 diabetes determined by self-report with verification
Beschrijving

Diabetes Mellitus, Non-Insulin-Dependent

Datatype

boolean

Alias
UMLS CUI [1]
C0011860
6.5% < hba1c < 11%
Beschrijving

Hemoglobin A1c measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0474680
sedentary lifestyle - not being physically active greater than or equal to 3 days per week for 20 minutes each time for the previous 6 months, and not performing regular resistance exercise
Beschrijving

Sedentary lifestyle | Physical activity Duration days/week | Resistive exercise Regular Absent

Datatype

boolean

Alias
UMLS CUI [1]
C1532253
UMLS CUI [2,1]
C0026606
UMLS CUI [2,2]
C0449238
UMLS CUI [2,3]
C0677547
UMLS CUI [3,1]
C0203991
UMLS CUI [3,2]
C0205272
UMLS CUI [3,3]
C0332197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
inadequate control of co-morbid conditions
Beschrijving

Comorbidity Poorly controlled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C3853134
resting blood pressure greater than or equal to 160/100 mm hg
Beschrijving

Blood pressure determination At rest

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005824
UMLS CUI [1,2]
C0443144
triglycerides greater than or equal to 500 mg/dl
Beschrijving

Triglycerides measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0202236
bmi is greater than or equal to 48
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
current use of an insulin pump or insulin injections other than lantus
Beschrijving

Use of Insulin pump | Insulin injection | Exception Lantus

Datatype

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C1140609
UMLS CUI [2]
C0199782
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0876064
metal object in the body that may interfere with mri/mrs scans
Beschrijving

Metallic material Body Interferes with MRI scan | Metallic material Body Interferes with MRS

Datatype

boolean

Alias
UMLS CUI [1,1]
C0567346
UMLS CUI [1,2]
C1268086
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0024485
UMLS CUI [2,1]
C0567346
UMLS CUI [2,2]
C1268086
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0024487
factors that may limit adherence to intervention or affect conduct of the trial
Beschrijving

Factor Limiting Adherence Intervention | Factor Affecting Completion of clinical trial

Datatype

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C1510802
UMLS CUI [1,4]
C0184661
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C2732579
1. unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment
Beschrijving

Lacking Able to communicate Research Personnel | Communication Research Personnel Unwilling | Informed Consent Unable | Informed Consent Unwilling | Randomization Unable | Randomization Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2364293
UMLS CUI [1,3]
C0035173
UMLS CUI [2,1]
C0009452
UMLS CUI [2,2]
C0035173
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0021430
UMLS CUI [3,2]
C1299582
UMLS CUI [4,1]
C0021430
UMLS CUI [4,2]
C0558080
UMLS CUI [5,1]
C0034656
UMLS CUI [5,2]
C1299582
UMLS CUI [6,1]
C0034656
UMLS CUI [6,2]
C0558080
2. failure to complete behavioral run-in and baseline testing
Beschrijving

Run-in Behavioral Completion failed | Baseline Testing failed

Datatype

boolean

Alias
UMLS CUI [1,1]
C3274438
UMLS CUI [1,2]
C0004927
UMLS CUI [1,3]
C0205197
UMLS CUI [1,4]
C0231175
UMLS CUI [2,1]
C1442488
UMLS CUI [2,2]
C0039593
UMLS CUI [2,3]
C0231175
3. hospitalization for depression in the last 6 months
Beschrijving

Hospitalization Due to Depressive disorder

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0011581
4. not physically capable of performing the exercise required for the study protocols
Beschrijving

Study Protocol Exercise Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0015259
UMLS CUI [1,3]
C1299582
5. consuming > 14 alcoholic beverages per week
Beschrijving

Alcohol consumption units/week

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0560579
6. plans to be away > 4 weeks in the next 9 months
Beschrijving

Patient unavailable Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301818
UMLS CUI [1,2]
C0449238
7. lack of support from primary health care provider or family members
Beschrijving

Primary care provider Support Lacking | Lack of family support

Datatype

boolean

Alias
UMLS CUI [1,1]
C2735026
UMLS CUI [1,2]
C1521721
UMLS CUI [1,3]
C0332268
UMLS CUI [2]
C2364078
8. significant weight loss in the past year (>20 lbs) or current use of weight loss medications
Beschrijving

Weight loss Significant | Weight-Loss Agents

Datatype

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0376606
9. current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
Beschrijving

Schizophrenia | Psychotic Disorders | Bipolar Disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0036341
UMLS CUI [2]
C0033975
UMLS CUI [3]
C0005586
10. another member of household is a participant or staff member of hart-d
Beschrijving

Study Subject Participation Status | Household Member

Datatype

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C4330269
11. bariatric surgery
Beschrijving

Bariatric Surgery

Datatype

boolean

Alias
UMLS CUI [1]
C1456587
12. other temporary intervening event, such as sick spouse, bereavement, or recent move
Beschrijving

Event Temporary | Sick spouse | Bereavement | Relocation of home

Datatype

boolean

Alias
UMLS CUI [1,1]
C0441471
UMLS CUI [1,2]
C0205374
UMLS CUI [2]
C0857764
UMLS CUI [3]
C0005119
UMLS CUI [4]
C2699029
13. other medical, psychiatric, or behavioral limitations that, in the view of the principal investigator, may interfere with study participation or the ability to follow the intervention protocol
Beschrijving

Limitation Medical Interferes with Study Subject Participation Status | Limitation Medical Interferes with Protocol Compliance | Mental handicap Interferes with Study Subject Participation Status | Mental handicap Interferes with Protocol Compliance | Behavioral disability Interferes with Study Subject Participation Status | Behavioral disability Interferes with Protocol Compliance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0449295
UMLS CUI [1,2]
C0205476
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C2348568
UMLS CUI [2,1]
C0449295
UMLS CUI [2,2]
C0205476
UMLS CUI [2,3]
C0521102
UMLS CUI [2,4]
C0525058
UMLS CUI [3,1]
C1306341
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C1306341
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0525058
UMLS CUI [5,1]
C1291707
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C2348568
UMLS CUI [6,1]
C1291707
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C0525058
underlying diseases or conditions likely to limit lifespan and/or affect the safety of the intervention
Beschrijving

Primary disorders Limiting Life span | Primary disorders Affecting Safety Intervention

Datatype

boolean

Alias
UMLS CUI [1,1]
C0277554
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0870809
UMLS CUI [2,1]
C0277554
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0036043
UMLS CUI [2,4]
C0184661
1. pregnant or plan on becoming pregnant in the next 9 months
Beschrijving

Pregnancy | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
2. cancers requiring treatment in the past 5 years, unless prognosis is excellent
Beschrijving

Malignant Neoplasms Treatment required for | Exception Prognosis Excellent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0033325
UMLS CUI [2,3]
C1961136
3. self-reported hiv or tuberculosis
Beschrijving

HIV Infection | Tuberculosis

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0041296
4. history or evidence of serious arrythmias, cardiomyopathy, congestive heart failure, aortic aneurysm, or heart transplantation
Beschrijving

Cardiac Arrhythmia Serious | Cardiomyopathy | Congestive heart failure | Aortic Aneurysm | Heart Transplantation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0878544
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0003486
UMLS CUI [5]
C0018823
5. renal disease: urine dipstick 4+ protein, serum creatinine is greater than or equal to 1.4 mg/dl (women) or is greater than or equal to 1.5 mg/dl (men) or currently receiving dialysis
Beschrijving

Kidney Disease | Urine dipstick for protein | Creatinine measurement, serum | Gender | Dialysis

Datatype

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0430371
UMLS CUI [3]
C0201976
UMLS CUI [4]
C0079399
UMLS CUI [5]
C0011946
6. any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise
Beschrijving

Other medical condition Life Threatening | Life threatening illness | Other medical condition Interferes with Exercise | Disease Interferes with Exercise | Disease Exacerbation Due to Exercise

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C3846017
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0015259
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0015259
UMLS CUI [5,1]
C0235874
UMLS CUI [5,2]
C0678226
UMLS CUI [5,3]
C0015259
7. advanced neuropathy or retinopathy
Beschrijving

Neuropathy Advanced | Retinal Disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0035309
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Similar models

Eligibility Type 2 Diabetes NCT00458133

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age 30-75 years
boolean
C0001779 (UMLS CUI [1])
Diabetes Mellitus, Non-Insulin-Dependent
Item
type 2 diabetes determined by self-report with verification
boolean
C0011860 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
6.5% < hba1c < 11%
boolean
C0474680 (UMLS CUI [1])
Sedentary lifestyle | Physical activity Duration days/week | Resistive exercise Regular Absent
Item
sedentary lifestyle - not being physically active greater than or equal to 3 days per week for 20 minutes each time for the previous 6 months, and not performing regular resistance exercise
boolean
C1532253 (UMLS CUI [1])
C0026606 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0677547 (UMLS CUI [2,3])
C0203991 (UMLS CUI [3,1])
C0205272 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Comorbidity Poorly controlled
Item
inadequate control of co-morbid conditions
boolean
C0009488 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
Blood pressure determination At rest
Item
resting blood pressure greater than or equal to 160/100 mm hg
boolean
C0005824 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
Triglycerides measurement
Item
triglycerides greater than or equal to 500 mg/dl
boolean
C0202236 (UMLS CUI [1])
Body mass index
Item
bmi is greater than or equal to 48
boolean
C1305855 (UMLS CUI [1])
Use of Insulin pump | Insulin injection | Exception Lantus
Item
current use of an insulin pump or insulin injections other than lantus
boolean
C1524063 (UMLS CUI [1,1])
C1140609 (UMLS CUI [1,2])
C0199782 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0876064 (UMLS CUI [3,2])
Metallic material Body Interferes with MRI scan | Metallic material Body Interferes with MRS
Item
metal object in the body that may interfere with mri/mrs scans
boolean
C0567346 (UMLS CUI [1,1])
C1268086 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0024485 (UMLS CUI [1,4])
C0567346 (UMLS CUI [2,1])
C1268086 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0024487 (UMLS CUI [2,4])
Factor Limiting Adherence Intervention | Factor Affecting Completion of clinical trial
Item
factors that may limit adherence to intervention or affect conduct of the trial
boolean
C1521761 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C1510802 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,4])
C1521761 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Lacking Able to communicate Research Personnel | Communication Research Personnel Unwilling | Informed Consent Unable | Informed Consent Unwilling | Randomization Unable | Randomization Unwilling
Item
1. unable or unwilling to communicate with staff, to provide written informed consent, or accept the randomized assignment
boolean
C0332268 (UMLS CUI [1,1])
C2364293 (UMLS CUI [1,2])
C0035173 (UMLS CUI [1,3])
C0009452 (UMLS CUI [2,1])
C0035173 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0021430 (UMLS CUI [3,1])
C1299582 (UMLS CUI [3,2])
C0021430 (UMLS CUI [4,1])
C0558080 (UMLS CUI [4,2])
C0034656 (UMLS CUI [5,1])
C1299582 (UMLS CUI [5,2])
C0034656 (UMLS CUI [6,1])
C0558080 (UMLS CUI [6,2])
Run-in Behavioral Completion failed | Baseline Testing failed
Item
2. failure to complete behavioral run-in and baseline testing
boolean
C3274438 (UMLS CUI [1,1])
C0004927 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
C1442488 (UMLS CUI [2,1])
C0039593 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
Hospitalization Due to Depressive disorder
Item
3. hospitalization for depression in the last 6 months
boolean
C0019993 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0011581 (UMLS CUI [1,3])
Study Protocol Exercise Unable
Item
4. not physically capable of performing the exercise required for the study protocols
boolean
C2348563 (UMLS CUI [1,1])
C0015259 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Alcohol consumption units/week
Item
5. consuming > 14 alcoholic beverages per week
boolean
C0001948 (UMLS CUI [1,1])
C0560579 (UMLS CUI [1,2])
Patient unavailable Duration
Item
6. plans to be away > 4 weeks in the next 9 months
boolean
C1301818 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Primary care provider Support Lacking | Lack of family support
Item
7. lack of support from primary health care provider or family members
boolean
C2735026 (UMLS CUI [1,1])
C1521721 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C2364078 (UMLS CUI [2])
Weight loss Significant | Weight-Loss Agents
Item
8. significant weight loss in the past year (>20 lbs) or current use of weight loss medications
boolean
C1262477 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0376606 (UMLS CUI [2])
Schizophrenia | Psychotic Disorders | Bipolar Disorder
Item
9. current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
boolean
C0036341 (UMLS CUI [1])
C0033975 (UMLS CUI [2])
C0005586 (UMLS CUI [3])
Study Subject Participation Status | Household Member
Item
10. another member of household is a participant or staff member of hart-d
boolean
C2348568 (UMLS CUI [1])
C4330269 (UMLS CUI [2])
Bariatric Surgery
Item
11. bariatric surgery
boolean
C1456587 (UMLS CUI [1])
Event Temporary | Sick spouse | Bereavement | Relocation of home
Item
12. other temporary intervening event, such as sick spouse, bereavement, or recent move
boolean
C0441471 (UMLS CUI [1,1])
C0205374 (UMLS CUI [1,2])
C0857764 (UMLS CUI [2])
C0005119 (UMLS CUI [3])
C2699029 (UMLS CUI [4])
Limitation Medical Interferes with Study Subject Participation Status | Limitation Medical Interferes with Protocol Compliance | Mental handicap Interferes with Study Subject Participation Status | Mental handicap Interferes with Protocol Compliance | Behavioral disability Interferes with Study Subject Participation Status | Behavioral disability Interferes with Protocol Compliance
Item
13. other medical, psychiatric, or behavioral limitations that, in the view of the principal investigator, may interfere with study participation or the ability to follow the intervention protocol
boolean
C0449295 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C0449295 (UMLS CUI [2,1])
C0205476 (UMLS CUI [2,2])
C0521102 (UMLS CUI [2,3])
C0525058 (UMLS CUI [2,4])
C1306341 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C1306341 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
C1291707 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348568 (UMLS CUI [5,3])
C1291707 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
Primary disorders Limiting Life span | Primary disorders Affecting Safety Intervention
Item
underlying diseases or conditions likely to limit lifespan and/or affect the safety of the intervention
boolean
C0277554 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0870809 (UMLS CUI [1,3])
C0277554 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0036043 (UMLS CUI [2,3])
C0184661 (UMLS CUI [2,4])
Pregnancy | Pregnancy, Planned
Item
1. pregnant or plan on becoming pregnant in the next 9 months
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Malignant Neoplasms Treatment required for | Exception Prognosis Excellent
Item
2. cancers requiring treatment in the past 5 years, unless prognosis is excellent
boolean
C0006826 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0033325 (UMLS CUI [2,2])
C1961136 (UMLS CUI [2,3])
HIV Infection | Tuberculosis
Item
3. self-reported hiv or tuberculosis
boolean
C0019693 (UMLS CUI [1])
C0041296 (UMLS CUI [2])
Cardiac Arrhythmia Serious | Cardiomyopathy | Congestive heart failure | Aortic Aneurysm | Heart Transplantation
Item
4. history or evidence of serious arrythmias, cardiomyopathy, congestive heart failure, aortic aneurysm, or heart transplantation
boolean
C0003811 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0878544 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0003486 (UMLS CUI [4])
C0018823 (UMLS CUI [5])
Kidney Disease | Urine dipstick for protein | Creatinine measurement, serum | Gender | Dialysis
Item
5. renal disease: urine dipstick 4+ protein, serum creatinine is greater than or equal to 1.4 mg/dl (women) or is greater than or equal to 1.5 mg/dl (men) or currently receiving dialysis
boolean
C0022658 (UMLS CUI [1])
C0430371 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
C0079399 (UMLS CUI [4])
C0011946 (UMLS CUI [5])
Other medical condition Life Threatening | Life threatening illness | Other medical condition Interferes with Exercise | Disease Interferes with Exercise | Disease Exacerbation Due to Exercise
Item
6. any other medical condition or disease that is life threatening or that can interfere with or be aggravated by exercise
boolean
C3843040 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C3846017 (UMLS CUI [2])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0015259 (UMLS CUI [3,3])
C0012634 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0015259 (UMLS CUI [4,3])
C0235874 (UMLS CUI [5,1])
C0678226 (UMLS CUI [5,2])
C0015259 (UMLS CUI [5,3])
Neuropathy Advanced | Retinal Disease
Item
7. advanced neuropathy or retinopathy
boolean
C0442874 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0035309 (UMLS CUI [2])
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