Inglés

PART A - Period 2 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 formularios  
Orthostatic blood pressure / Pulse - Predose
Descripción

Orthostatic blood pressure / Pulse - Predose

Alias
UMLS CUI-1
C0518766
UMLS CUI-2
C1095971
UMLS CUI-3
C0232117
UMLS CUI-4
C3812758
Date of visit
Descripción

For the pre-dose measurements in Part A, Day 1 of Periods 1 and 2, and Part B, Day 1 of Periods 1 and 2, 3 sets of semi-supine and erect blood pressure and pulse measurements will be taken, commencing approximately 40 minutes prior to dosing and each set will be separated by 10 minutes rest in the semi- supine position. Three stable measurements should be recorded In this instance stable is defined as the three semi-supine diastolic measurements being within 15 mmHg of the lowest measurement. This rule also applies for the semi-supine systolic and erect systolic and diastolic measurements. A maximum of six attempts can be made to obtain measurements pre-dose. If three consecutive stable measurements of blood pressure cannot be obtained then the Investigator should contact the Medical Monitor to discuss whether the patient can be included/continue in the study.

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1320303
UMLS CUI [1,2]
C3812758
Heart Rate semi-supine
Descripción

Heart rate Semi-Supine

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C3812758
bpm
Heart Rate standing
Descripción

Heart Rate standing

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C2029905
UMLS CUI [1,2]
C3812758
bpm
Systolic blood pressure semi-supine
Descripción

Systolic blood pressure semi-supine

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C3812758
mmHg
Diastolic blood pressure semi-supine
Descripción

Diastolic blood pressure semi-supine

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C3812758
mmHg
Systolic blood pressure standing
Descripción

Systolic blood pressure standing

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
UMLS CUI [1,3]
C3812758
mmHg
Diastolic blood pressure standing
Descripción

Diastolic blood pressure standing

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C1303019
UMLS CUI [1,2]
C3812758
mmHg
Pregnancy test
Descripción

Pregnancy test

Alias
UMLS CUI-1
C0032976
Was a pregnancy test performed?
Descripción

pregnancy test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0032976
If yes, what type of pregnancy test was performed?
Descripción

pregnancy test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0032976
Date of pregnancy test
Descripción

Date of pregnancy test

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Result
Descripción

Result of pregnancy test

Tipo de datos

integer

Alias
UMLS CUI [1]
C0427777
Patient diary
Descripción

Patient diary

Alias
UMLS CUI-1
C3890583
Please collect and review the Patient Diary with the subject. If corrections or additional information are required, please ask the subject to provide missing information or clarification. Please use the Comments CRF pages as necessary. Document any missed doses on the appropriate CRF page. Please inform the subject that he/she should bring back the diary at the next visit.
Descripción

Patient diary

Tipo de datos

text

Alias
UMLS CUI [1]
C3890583
Alcohol breath/ blood test
Descripción

Alcohol breath/ blood test

Alias
UMLS CUI-1
C0202304
Time
Descripción

Perform Alcohol Breath/Blood Test and attach printout

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C0040223
Result
Descripción

Result of alcohol test

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0202304
UMLS CUI [1,2]
C1274040
Subjects MUST refrain from consuming alcohol for 24h prior to the screening and follow - up visits and for 24 hours before and throughout Parts A and B Has this subject consumed alcohol within the previous 24h?
Descripción

alcohol consumption

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0443288
Drug screening (urine)
Descripción

Drug screening (urine)

Alias
UMLS CUI-1
C0202274
Time
Descripción

Time of drug screening

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0040223
UMLS CUI [1,2]
C0202274
Cannabinoids
Descripción

Cannabinoids urine

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0006864
Morphine and morphine derivates
Descripción

Morphine and morphine derivates urine

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0279996
Amphetamine
Descripción

Amphetamine urine

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0002667
Barbiturates
Descripción

Barbiturates urine

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0004745
Benzodiazepines
Descripción

Benzodiazepines urine

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0005064
Cocaine
Descripción

Cocaine urine

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0202274
UMLS CUI [1,2]
C0009170
Tricyclic antidepressants
Descripción

Tricyclic antidepressants urine

Tipo de datos

integer

Alias
UMLS CUI [1]
C0003290
If positive, give further details.
Descripción

Urine drug screening positive specify

Tipo de datos

text

Alias
UMLS CUI [1,1]
C2711519
UMLS CUI [1,2]
C1521902
Concomitant medication
Descripción

Concomitant medication

Alias
UMLS CUI-1
C2347852
Has the subject had any changes in medication since the last study visit?
Descripción

If 'Yes', please document on the Concomitant Medication Report Forms.

Tipo de datos

integer

Alias
UMLS CUI [1]
C0580105
Have the subject's smoking habits remained unchanged?
Descripción

tobacco use unchanged

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0543414
UMLS CUI [1,2]
C0442739
Has the subject complied with suggested dietary restrictions?
Descripción

dietary restrictions

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0425422
UMLS CUI [1,2]
C1321605
Adverse event
Descripción

Adverse event

Alias
UMLS CUI-1
C0877248
Has the subject experienced any Adverse Events since the last study contact?
Descripción

If 'Yes', please document on the Adverse Event Report Forms.

Tipo de datos

integer

Alias
UMLS CUI [1]
C0877248
Standard Breakfast
Descripción

Standard Breakfast

Alias
UMLS CUI-1
C2698559
Breakfast started
Descripción

Breakfast started

Tipo de datos

time

Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0439659
Breakfast ended
Descripción

Breakfast ended

Tipo de datos

time

Alias
UMLS CUI [1,1]
C2698559
UMLS CUI [1,2]
C0444930
Did the subject complete the breakfast?
Descripción

Breakfast completed

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0814440
UMLS CUI [1,2]
C0205197
If no, please comment:
Descripción

Breakfast not completed comment

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0947611
UMLS CUI [1,2]
C0814440
UMLS CUI [1,3]
C0205197
Study Drug Dosing
Descripción

Study Drug Dosing

Alias
UMLS CUI-1
C0013175
UMLS CUI-2
C0678766
Dosage given
Descripción

The subject will not be allowed to lie down or sleep for 4 hours after the morning dose.

Tipo de datos

float

Unidades de medida
  • mg/day
Alias
UMLS CUI [1]
C0678766
mg/day
Dosage
Descripción

Dosage

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C3854006
Time of dosing
Descripción

Time of Dosing

Tipo de datos

time

Unidades de medida
  • 24hr:min
Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0040223
24hr:min
Witness 1
Descripción

Witness 1

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C0001555
Witness 2
Descripción

Witness 2

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0682356
UMLS CUI [1,2]
C0001555
Witness date
Descripción

Witness date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C4263486
UMLS CUI [1,2]
C0011008
Orthostatic blood pressure / pulse measurement - post dose
Descripción

Orthostatic blood pressure / pulse measurement - post dose

Alias
UMLS CUI-1
C1095971
UMLS CUI-2
C0232117
UMLS CUI-3
C0439568
Time point
Descripción

Date of visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1320303
Post dose
Descripción

Post dose

Tipo de datos

integer

Alias
UMLS CUI [1]
C0439568
Post dose
Descripción

Post dose

Tipo de datos

integer

Alias
UMLS CUI [1]
C0439568
Time of post dose
Descripción

Time post dose

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0439568
UMLS CUI [1,2]
C0040223
Heart Rate semi-supine
Descripción

Heart rate Semi-Supine

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C0439568
bpm
Heart Rate standing
Descripción

Heart Rate standing

Tipo de datos

integer

Unidades de medida
  • bpm
Alias
UMLS CUI [1,1]
C2029905
UMLS CUI [1,2]
C0439568
bpm
Systolic blood pressure semi-supine
Descripción

Systolic blood pressure semi-supine

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C0439568
mmHg
Diastolic blood pressure semi-supine
Descripción

Diastolic blood pressure semi-supine

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C0439568
mmHg
Systolic blood pressure standing
Descripción

Systolic blood pressure standing

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0231472
UMLS CUI [1,3]
C0439568
mmHg
Diastolic blood pressure standing
Descripción

Diastolic blood pressure standing

Tipo de datos

integer

Unidades de medida
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0231472
UMLS CUI [1,3]
C0439568
mmHg
Adverse Event - 4 hours post dosing
Descripción

Adverse Event - 4 hours post dosing

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0439574
Has the subject experienced any Adverse Events since the time of dosing?
Descripción

If Yes , please document on the Adverse Event Report Forms

Tipo de datos

integer

Alias
UMLS CUI [1]
C0877248
Discharge
Descripción

Discharge

Alias
UMLS CUI-1
C0030685
Was study medication dispensed to the subject?
Descripción

For subjects randomized to IR formulation, please ensure sufficient medication has been dispensed and that the subject is instructed re: self administration

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C3854006
UMLS CUI [1,2]
C0947323
Time of discharge from study site
Descripción

Discharge Time

Tipo de datos

time

Alias
UMLS CUI [1]
C3864299
Date of next study visit
Descripción

Date of next study visit

Tipo de datos

date

Alias
UMLS CUI [1]
C1545257
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Similar models

PART A - Period 2 - Day 1 - Ropinirole and the effect of food in early stage Parkinson’s disease subjects 101468/164

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Orthostatic blood pressure / Pulse - Predose
C0518766 (UMLS CUI-1)
C1095971 (UMLS CUI-2)
C0232117 (UMLS CUI-3)
C3812758 (UMLS CUI-4)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1,1])
C3812758 (UMLS CUI [1,2])
Heart rate Semi-Supine
Item
Heart Rate semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Heart Rate standing
Item
Heart Rate standing
integer
C2029905 (UMLS CUI [1,1])
C3812758 (UMLS CUI [1,2])
Systolic blood pressure semi-supine
Item
Systolic blood pressure semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Diastolic blood pressure semi-supine
Item
Diastolic blood pressure semi-supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Systolic blood pressure standing
Item
Systolic blood pressure standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C3812758 (UMLS CUI [1,3])
Diastolic blood pressure standing
Item
Diastolic blood pressure standing
integer
C1303019 (UMLS CUI [1,1])
C3812758 (UMLS CUI [1,2])
Item Group
Pregnancy test
C0032976 (UMLS CUI-1)
Item
Was a pregnancy test performed?
integer
C0032976 (UMLS CUI [1])
pregnancy test
Code List
Was a pregnancy test performed?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Item
If yes, what type of pregnancy test was performed?
integer
C0032976 (UMLS CUI [1])
pregnancy test
Code List
If yes, what type of pregnancy test was performed?
CL Item
Serum (1)
CL Item
Urine (2)
Date of pregnancy test
Item
Date of pregnancy test
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Result
integer
C0427777 (UMLS CUI [1])
Result of pregnancy test
Code List
Result
CL Item
positive (1)
CL Item
negative (2)
Item Group
Patient diary
C3890583 (UMLS CUI-1)
Patient diary
Item
Please collect and review the Patient Diary with the subject. If corrections or additional information are required, please ask the subject to provide missing information or clarification. Please use the Comments CRF pages as necessary. Document any missed doses on the appropriate CRF page. Please inform the subject that he/she should bring back the diary at the next visit.
text
C3890583 (UMLS CUI [1])
Item Group
Alcohol breath/ blood test
C0202304 (UMLS CUI-1)
Time of alcohol test
Item
Time
time
C0202304 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Result
integer
C0202304 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Result of alcohol test
Code List
Result
CL Item
negative (1)
CL Item
positive (2)
alcohol consumption
Item
Subjects MUST refrain from consuming alcohol for 24h prior to the screening and follow - up visits and for 24 hours before and throughout Parts A and B Has this subject consumed alcohol within the previous 24h?
boolean
C0001948 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
Item Group
Drug screening (urine)
C0202274 (UMLS CUI-1)
Time of drug screening
Item
Time
time
C0040223 (UMLS CUI [1,1])
C0202274 (UMLS CUI [1,2])
Item
Cannabinoids
integer
C0202274 (UMLS CUI [1,1])
C0006864 (UMLS CUI [1,2])
Cannabinoids urine
Code List
Cannabinoids
CL Item
negative (1)
CL Item
positive (2)
Item
Morphine and morphine derivates
integer
C0202274 (UMLS CUI [1,1])
C0279996 (UMLS CUI [1,2])
Morphine and morphine derivates urine
Code List
Morphine and morphine derivates
CL Item
negative (1)
CL Item
positive (2)
Item
Amphetamine
integer
C0202274 (UMLS CUI [1,1])
C0002667 (UMLS CUI [1,2])
Amphetamine urine
Code List
Amphetamine
CL Item
negative (1)
CL Item
positive (2)
Item
Barbiturates
integer
C0202274 (UMLS CUI [1,1])
C0004745 (UMLS CUI [1,2])
Barbiturates urine
Code List
Barbiturates
CL Item
negative (1)
CL Item
positive (2)
Item
Benzodiazepines
integer
C0202274 (UMLS CUI [1,1])
C0005064 (UMLS CUI [1,2])
Benzodiazepines urine
Code List
Benzodiazepines
CL Item
negative (1)
CL Item
positive (2)
Item
Cocaine
integer
C0202274 (UMLS CUI [1,1])
C0009170 (UMLS CUI [1,2])
Cocaine urine
Code List
Cocaine
CL Item
negative (1)
CL Item
positive (2)
Item
Tricyclic antidepressants
integer
C0003290 (UMLS CUI [1])
Tricyclic antidepressants urine
Code List
Tricyclic antidepressants
CL Item
negative (1)
CL Item
positive (2)
Urine drug screening positive specify
Item
If positive, give further details.
text
C2711519 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Concomitant medication
C2347852 (UMLS CUI-1)
Item
Has the subject had any changes in medication since the last study visit?
integer
C0580105 (UMLS CUI [1])
changes in medication
Code List
Has the subject had any changes in medication since the last study visit?
CL Item
Yes (1)
CL Item
No (2)
Item
Have the subject's smoking habits remained unchanged?
integer
C0543414 (UMLS CUI [1,1])
C0442739 (UMLS CUI [1,2])
tobacco use unchanged
Code List
Have the subject's smoking habits remained unchanged?
CL Item
Yes (1)
CL Item
No (2)
Item
Has the subject complied with suggested dietary restrictions?
integer
C0425422 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
dietary restrictions
Code List
Has the subject complied with suggested dietary restrictions?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Adverse event
C0877248 (UMLS CUI-1)
Item
Has the subject experienced any Adverse Events since the last study contact?
integer
C0877248 (UMLS CUI [1])
adverse event
Code List
Has the subject experienced any Adverse Events since the last study contact?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Standard Breakfast
C2698559 (UMLS CUI-1)
Breakfast started
Item
Breakfast started
time
C2698559 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
Breakfast ended
Item
Breakfast ended
time
C2698559 (UMLS CUI [1,1])
C0444930 (UMLS CUI [1,2])
Breakfast completed
Item
Did the subject complete the breakfast?
boolean
C0814440 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Breakfast not completed comment
Item
If no, please comment:
text
C0947611 (UMLS CUI [1,1])
C0814440 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Item Group
Study Drug Dosing
C0013175 (UMLS CUI-1)
C0678766 (UMLS CUI-2)
Dosage given
Item
Dosage given
float
C0678766 (UMLS CUI [1])
Item
Dosage
integer
C0178602 (UMLS CUI [1,1])
C3854006 (UMLS CUI [1,2])
Dosage
Code List
Dosage
CL Item
CR (1)
CL Item
IR (2)
Time of Dosing
Item
Time of dosing
time
C0178602 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Witness 1
Item
Witness 1
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness 2
Item
Witness 2
text
C0682356 (UMLS CUI [1,1])
C0001555 (UMLS CUI [1,2])
Witness date
Item
Witness date
date
C4263486 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Orthostatic blood pressure / pulse measurement - post dose
C1095971 (UMLS CUI-1)
C0232117 (UMLS CUI-2)
C0439568 (UMLS CUI-3)
Date of visit
Item
Time point
date
C1320303 (UMLS CUI [1])
Item
Post dose
integer
C0439568 (UMLS CUI [1])
Post dose
Code List
Post dose
CL Item
1h post dose (1)
CL Item
2h post dose (2)
CL Item
3h post dose (3)
CL Item
4h post dose (4)
Item
Post dose
integer
C0439568 (UMLS CUI [1])
Post dose
Code List
Post dose
CL Item
1h post dose (1)
CL Item
2h post dose (2)
CL Item
3h post dose (3)
CL Item
4h post dose (4)
Time post dose
Item
Time of post dose
time
C0439568 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Heart rate Semi-Supine
Item
Heart Rate semi-supine
integer
C0018810 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Heart Rate standing
Item
Heart Rate standing
integer
C2029905 (UMLS CUI [1,1])
C0439568 (UMLS CUI [1,2])
Systolic blood pressure semi-supine
Item
Systolic blood pressure semi-supine
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Diastolic blood pressure semi-supine
Item
Diastolic blood pressure semi-supine
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Systolic blood pressure standing
Item
Systolic blood pressure standing
integer
C0871470 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Diastolic blood pressure standing
Item
Diastolic blood pressure standing
integer
C0428883 (UMLS CUI [1,1])
C0231472 (UMLS CUI [1,2])
C0439568 (UMLS CUI [1,3])
Item Group
Adverse Event - 4 hours post dosing
C0877248 (UMLS CUI-1)
C0439574 (UMLS CUI-2)
Item
Has the subject experienced any Adverse Events since the time of dosing?
integer
C0877248 (UMLS CUI [1])
adverse event
Code List
Has the subject experienced any Adverse Events since the time of dosing?
CL Item
Yes (1)
CL Item
No (2)
Item Group
Discharge
C0030685 (UMLS CUI-1)
Item
Was study medication dispensed to the subject?
integer
C3854006 (UMLS CUI [1,1])
C0947323 (UMLS CUI [1,2])
Study medication dispensed
Code List
Was study medication dispensed to the subject?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Discharge Time
Item
Time of discharge from study site
time
C3864299 (UMLS CUI [1])
Date of next study visit
Item
Date of next study visit
date
C1545257 (UMLS CUI [1])
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