ID

24042

Beskrivning

Module 2 - Screening & Repeat Tests 101468/243 Study ID: 101468/243 Clinical Study ID: 101468/243 Study Title: A 52 Week Open-Label Extension Study of the Long-Term Safety of Ropinirole in Subjects Suffering from Restless Legs Syndrome (RLS) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: N/A Sponsor:GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Nyckelord

  1. 2017-07-23 2017-07-23 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

23 juli 2017

DOI

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Creative Commons BY-NC 3.0

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GSK study: Ropinirole in RLS patients 101468/243 - Screening & Repeat Tests

GSK study: Ropinirole in RLS patients 101468/243 - Screening & Repeat Tests

Vital signs
Beskrivning

Vital signs

Alias
UMLS CUI-1
C0518766
Pulse
Beskrivning

after 5 minutes sitting

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Sitting systolic Blood Pressure
Beskrivning

after 5 minutes sitting

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0277814
mmHg
Sitting diastolic blood pressure
Beskrivning

after 5 min sitting

Datatyp

integer

Måttenheter
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0277814
mmHg
Laboratory Evaluation
Beskrivning

Laboratory Evaluation

Alias
UMLS CUI-1
C0022877
Date of blood sample
Beskrivning

Date of blood sample

Datatyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Please affix the Quest Diagnostics Laboratory label here.
Beskrivning

(Affix label only if sample was sent to Quest)

Datatyp

text

Alias
UMLS CUI [1]
C4273937
Were any clinically significant abnormalities detected?
Beskrivning

If "Yes", please record the diagnosis on the Baseline Signs and Symptoms page in this module and/or SAE page in separate pad and exclude the patient from the study.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1704258
Urine Dipstick
Beskrivning

Urine Dipstick

Alias
UMLS CUI-1
C0430370
What was the result of the urine dipstick performed at this visit?
Beskrivning

If ’Positive’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptom/SAE pages and send a sample to Quest Diagnostics for further evaluation.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984
Pregnancy dipstick
Beskrivning

Pregnancy dipstick

Alias
UMLS CUI-1
C0430056
Is the patient a female of child-bearing potential?
Beskrivning

If ’Yes’, please perform a pregnancy dipstick test and record result below.

Datatyp

integer

Alias
UMLS CUI [1]
C1960468
Pregnancy dipstick result
Beskrivning

If previous question was answered "yes", please perform a pregnancy dipstick test and record result below. If ’Positive’, please record details on the pregnancy form and exclude the patient.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C0456984
Medical Procedures
Beskrivning

Medical Procedures

Alias
UMLS CUI-1
C0199171
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
Beskrivning

If 'Yes', please record details below using standard medical terminology

Datatyp

integer

Alias
UMLS CUI [1]
C0199171
UMLS CUI [2]
C0087111
UMLS CUI [3]
C0430022
UMLS CUI [4]
C0543467
Medical Procedures
Beskrivning

Medical Procedures

Alias
UMLS CUI-1
C0199171
Procedure
Beskrivning

Procedure

Datatyp

text

Alias
UMLS CUI [1]
C0199171
Indication
Beskrivning

Indication of medical procedure

Datatyp

text

Alias
UMLS CUI [1,1]
C0199171
UMLS CUI [1,2]
C3146298
Procedure Start Date
Beskrivning

Procedure Start Date

Datatyp

date

Alias
UMLS CUI [1,1]
C0199171
UMLS CUI [1,2]
C0808070
End Date Procedure
Beskrivning

End Date Procedure

Datatyp

date

Alias
UMLS CUI [1,1]
C0199171
UMLS CUI [1,2]
C0806020
Prior and concomitant medication
Beskrivning

Prior and concomitant medication

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C2347852
Has the patient taken any medication (including any pharmacotherapy medication for treatment of RLS) since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
Beskrivning

If ‘Yes’, please record details below (Please print clearly)

Datatyp

integer

Alias
UMLS CUI [1,1]
C2826257
UMLS CUI [1,2]
C2347852
prior and concomitant medication
Beskrivning

prior and concomitant medication

Alias
UMLS CUI-1
C2826257
UMLS CUI-2
C2347852
Drug Name (Trade name preferred)
Beskrivning

Drug name

Datatyp

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0919189
Total daily dose
Beskrivning

eg. 500 mg

Datatyp

text

Alias
UMLS CUI [1]
C2348070
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
Beskrivning

or symptom in absence of diagnosis

Datatyp

text

Alias
UMLS CUI [1]
C0011900
Start Date (be as precise as possible)
Beskrivning

start date of medication

Datatyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End Date
Beskrivning

End Date of medication

Datatyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Does the medication still continue?
Beskrivning

medication is current

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521116
Baseline signs and symptoms
Beskrivning

Baseline signs and symptoms

Alias
UMLS CUI-1
C0037088
UMLS CUI-2
C1442488
Please mark this box if no baseline events occurred prior to randomisation into study.
Beskrivning

Baseline adverse reaction

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1442488
Baseline event
Beskrivning

Record any baseline events (using standard medical terminology) observed or elicited by the following direct question to patient: “Have you felt different in any way in the last 7 days?” Provide the diagnosis, not symptoms where possible. One baseline event per column.

Datatyp

text

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C1442488
Onset Date and Time
Beskrivning

Adverse Reaction Start Date Time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C2981441
UMLS CUI [1,2]
C1442488
End Date and Time
Beskrivning

(If ongoing please leave blank)

Datatyp

datetime

Alias
UMLS CUI [1,1]
C2981425
UMLS CUI [1,2]
C1442488
Outcome
Beskrivning

If patient died, STOP: go to SAE section and follow instructions given there

Datatyp

integer

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C1624730
Event Course
Beskrivning

adverse reaction course

Datatyp

integer

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0750729
Number of episodes
Beskrivning

only answer if previous answer was 'intermittent'

Datatyp

integer

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C4086638
Intensity (maximum)
Beskrivning

Intensity concerning the maximum

Datatyp

integer

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0518690
Relationship to study procedures performed prior to enrolment
Beskrivning

Relationship to study procedures

Datatyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1510821
Corrective Therapy
Beskrivning

If ‘Yes’, record details in Prior and Concomitant Medication section and/or Resource Utilisation section if appropriate

Datatyp

integer

Alias
UMLS CUI [1,1]
C0559546
UMLS CUI [1,2]
C0087111
Was patient withdrawn due to this specific event prior to randomisation?
Beskrivning

Study subject participation status due to adverse reaction

Datatyp

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0559546
UMLS CUI [1,3]
C0424092
Significant medical/surgical history and physical examination
Beskrivning

Significant medical/surgical history and physical examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-3
C0489540
UMLS CUI-5
C0031809
Is the patient suffering from or has he/she suffered from any significant medical or surgical condition since the last visit of the previous study (excluding RLS)?
Beskrivning

If 'Yes' , please list below one diagnosis per line.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0008976
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0008976
Significant medical/surgical history and physical examination
Beskrivning

Significant medical/surgical history and physical examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0489540
UMLS CUI-3
C0031809
Diagnosis
Beskrivning

Diagnosis

Datatyp

text

Alias
UMLS CUI [1]
C0011900
Year of first diagnosis (if know)
Beskrivning

Year of diagnosis

Datatyp

partialDate

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0439234
Past and/or ongoing (diagnosis)
Beskrivning

Past and/or ongoing medical history

Datatyp

integer

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0455458
UMLS CUI [2]
C2826680
Patient continuation/ withdrawal
Beskrivning

Patient continuation/ withdrawal

Alias
UMLS CUI-1
C2348568
Is the patient continuing in the study?
Beskrivning

If ’Yes’, please place this Module in the CRF (Book 1) If ’No’, please mark the primary cause of withdrawal. (Mark one box only).

Datatyp

integer

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0549178
Cause of withdrawal from study
Beskrivning

Cause of withdrawal from study

Datatyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0085978
Please specify 'other' cause of withdrawal from study.
Beskrivning

Other cause of withdrawal from study

Datatyp

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0205394
Investigator signature
Beskrivning

Investigator signature

Alias
UMLS CUI-1
C2346576
Investigator signature
Beskrivning

I certify that I have reviewed the data in this Case Report Form, including laboratory data and that in the Baseline Signs and Symptoms and Serious Adverse Experience sections (if appropriate) and that all information is complete and accurate.

Datatyp

text

Alias
UMLS CUI [1]
C2346576
Date
Beskrivning

Investigator Signature Date

Datatyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Repeated Laboratory Evaluation
Beskrivning

Repeated Laboratory Evaluation

Alias
UMLS CUI-1
C0022877
UMLS CUI-2
C0205341
Date of blood sample
Beskrivning

Date of blood sample

Datatyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Please affix the Quest Diagnostics Laboratory label here.
Beskrivning

Affix label only if sample was sent to Quest

Datatyp

text

Alias
UMLS CUI [1]
C4273937
Were any clinically significant abnormalities detected?
Beskrivning

If "Yes", please record the diagnosis on the Baseline Signs and Symptoms page in this module and/or SAE page in separate pad and exclude the patient from the study.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C1704258
Repeated Urine dipstick
Beskrivning

Repeated Urine dipstick

Alias
UMLS CUI-1
C0430370
UMLS CUI-2
C0205341
What was the result of the urine dipstick performed at this visit?
Beskrivning

If ’Positive’, please record details on the Significant Medical/Surgical History and Physical Examination or Baseline Signs and Symptom/SAE pages and send a sample to Quest Diagnostics for further evaluation.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0430370
UMLS CUI [1,2]
C0456984

Similar models

GSK study: Ropinirole in RLS patients 101468/243 - Screening & Repeat Tests

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
systolic blood pressure sitting
Item
Sitting systolic Blood Pressure
integer
C0871470 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
diastolic blood pressure sitting
Item
Sitting diastolic blood pressure
integer
C0428883 (UMLS CUI [1,1])
C0277814 (UMLS CUI [1,2])
Item Group
Laboratory Evaluation
C0022877 (UMLS CUI-1)
Date of blood sample
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
laboratory label
Item
Please affix the Quest Diagnostics Laboratory label here.
text
C4273937 (UMLS CUI [1])
Item
Were any clinically significant abnormalities detected?
integer
C0005834 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Code List
Were any clinically significant abnormalities detected?
CL Item
yes (1)
CL Item
no (2)
Item Group
Urine Dipstick
C0430370 (UMLS CUI-1)
Item
What was the result of the urine dipstick performed at this visit?
integer
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Code List
What was the result of the urine dipstick performed at this visit?
CL Item
Positive (2)
CL Item
Negative (1)
Item Group
Pregnancy dipstick
C0430056 (UMLS CUI-1)
Item
Is the patient a female of child-bearing potential?
integer
C1960468 (UMLS CUI [1])
Code List
Is the patient a female of child-bearing potential?
CL Item
no (1 )
CL Item
yes (2 )
Item
Pregnancy dipstick result
integer
C0430056 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Code List
Pregnancy dipstick result
CL Item
negative (1)
CL Item
positive (2)
Item Group
Medical Procedures
C0199171 (UMLS CUI-1)
Item
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
integer
C0199171 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0430022 (UMLS CUI [3])
C0543467 (UMLS CUI [4])
Code List
Have any non-medication, therapeutic, diagnostic or surgical procedures been performed since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
CL Item
No (1 )
CL Item
Yes (2)
Item Group
Medical Procedures
C0199171 (UMLS CUI-1)
Procedure
Item
Procedure
text
C0199171 (UMLS CUI [1])
Indication of medical procedure
Item
Indication
text
C0199171 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Procedure Start Date
Item
Procedure Start Date
date
C0199171 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date Procedure
Item
End Date Procedure
date
C0199171 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item Group
Prior and concomitant medication
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Item
Has the patient taken any medication (including any pharmacotherapy medication for treatment of RLS) since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
integer
C2826257 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Code List
Has the patient taken any medication (including any pharmacotherapy medication for treatment of RLS) since the last visit in the previous study or within the last 3 months (whichever is the shorter period)?
CL Item
no (1 )
CL Item
yes (2 )
Item Group
prior and concomitant medication
C2826257 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Drug name
Item
Drug Name (Trade name preferred)
text
C0013227 (UMLS CUI [1,1])
C0919189 (UMLS CUI [1,2])
Total Daily Dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1])
Diagnosis
Item
Medical Illness/ Diagnosis (or symptom in absence of diagnosis)
text
C0011900 (UMLS CUI [1])
start date of medication
Item
Start Date (be as precise as possible)
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End Date of medication
Item
End Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
medication is current
Item
Does the medication still continue?
boolean
C0013227 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Item Group
Baseline signs and symptoms
C0037088 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
Baseline adverse reaction
Item
Please mark this box if no baseline events occurred prior to randomisation into study.
boolean
C0037088 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Baseline adverse reaction
Item
Baseline event
text
C0559546 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Adverse Reaction Start Date Time
Item
Onset Date and Time
datetime
C2981441 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Adverse Reaction End Date Time
Item
End Date and Time
datetime
C2981425 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Item
Outcome
integer
C0559546 (UMLS CUI [1,1])
C1624730 (UMLS CUI [1,2])
Code List
Outcome
CL Item
resolved (1)
CL Item
ongoing (2)
CL Item
died (3)
Item
Event Course
integer
C0559546 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
Code List
Event Course
CL Item
intermittent (1)
CL Item
constant (2)
Number of episodes of adverse reaction
Item
Number of episodes
integer
C0559546 (UMLS CUI [1,1])
C4086638 (UMLS CUI [1,2])
Item
Intensity (maximum)
integer
C0559546 (UMLS CUI [1,1])
C0518690 (UMLS CUI [1,2])
Code List
Intensity (maximum)
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
Item
Relationship to study procedures performed prior to enrolment
integer
C0877248 (UMLS CUI [1,1])
C1510821 (UMLS CUI [1,2])
Code List
Relationship to study procedures performed prior to enrolment
CL Item
Related (5)
CL Item
Possibly related (6)
CL Item
Probably unrelated (7)
CL Item
Unrelated (1)
Item
Corrective Therapy
integer
C0559546 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Code List
Corrective Therapy
CL Item
yes (1)
CL Item
no (2)
Item
Was patient withdrawn due to this specific event prior to randomisation?
integer
C2348568 (UMLS CUI [1,1])
C0559546 (UMLS CUI [1,2])
C0424092 (UMLS CUI [1,3])
Code List
Was patient withdrawn due to this specific event prior to randomisation?
CL Item
yes (1)
CL Item
no (2)
Item Group
Significant medical/surgical history and physical examination
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-3)
C0031809 (UMLS CUI-5)
Item
Is the patient suffering from or has he/she suffered from any significant medical or surgical condition since the last visit of the previous study (excluding RLS)?
integer
C0012634 (UMLS CUI [1,1])
C0008976 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
Code List
Is the patient suffering from or has he/she suffered from any significant medical or surgical condition since the last visit of the previous study (excluding RLS)?
CL Item
No (1)
CL Item
Yes (2)
Item Group
Significant medical/surgical history and physical examination
C0262926 (UMLS CUI-1)
C0489540 (UMLS CUI-2)
C0031809 (UMLS CUI-3)
Diagnosis
Item
text
C0011900 (UMLS CUI [1])
Year of diagnosis
Item
Year of first diagnosis (if know)
partialDate
C0011900 (UMLS CUI [1,1])
C0439234 (UMLS CUI [1,2])
Item
Past and/or ongoing (diagnosis)
integer
C0011900 (UMLS CUI [1,1])
C0455458 (UMLS CUI [1,2])
C2826680 (UMLS CUI [2])
Code List
Past and/or ongoing (diagnosis)
CL Item
Past (1)
CL Item
ongoing (2)
CL Item
past+ongoing (3)
Item Group
Patient continuation/ withdrawal
C2348568 (UMLS CUI-1)
Item
Is the patient continuing in the study?
integer
C2348568 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Code List
Is the patient continuing in the study?
CL Item
Yes (1)
CL Item
No (2)
Item
Cause of withdrawal from study
text
C0422727 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
Code List
Cause of withdrawal from study
CL Item
Baseline sign and symptom (please complete Baseline Signs and Symptoms page)  (1)
CL Item
Does not meet inclusion/exclusion criteria (10)
CL Item
Protocol deviation (including non-compliance) (3)
CL Item
Lost to follow-up (4)
CL Item
Other-specify: (7)
Other cause of withdrawal from study
Item
Please specify 'other' cause of withdrawal from study.
text
C0422727 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Item Group
Investigator signature
C2346576 (UMLS CUI-1)
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Investigator Signature Date
Item
Date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Repeated Laboratory Evaluation
C0022877 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Date of blood sample
Item
Date of blood sample
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Laboratory label
Item
Please affix the Quest Diagnostics Laboratory label here.
text
C4273937 (UMLS CUI [1])
Item
Were any clinically significant abnormalities detected?
integer
C0005834 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Code List
Were any clinically significant abnormalities detected?
CL Item
yes (1)
CL Item
no (2)
Item Group
Repeated Urine dipstick
C0430370 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
Item
What was the result of the urine dipstick performed at this visit?
integer
C0430370 (UMLS CUI [1,1])
C0456984 (UMLS CUI [1,2])
Code List
What was the result of the urine dipstick performed at this visit?
CL Item
Positive (2)
CL Item
Negative (1)

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