ID

26490

Beschreibung

Study ID: 101468/190 Clinical Study ID: SKF-101468/190 Study Title:A 12 Week, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS). Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Requip Study Indication: Restless Legs Syndrome This is the Baseline form.

Stichworte

Versionen (2)
  1. 09.10.17 09.10.17 -
  2. 18.10.17 18.10.17 -
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GlaxoSmithKline

Hochgeladen am

18. Oktober 2017

DOI

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Baseline GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

Englisch

Baseline GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

1 Formulare  
General Information
Beschreibung

General Information

Alias
UMLS CUI-1
C1508263
UMLS CUI-2
C1955348
UMLS CUI-3
C0035258
Centre Number
Beschreibung

Centre Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C0600091
UMLS CUI [1,2]
C0019994
Patient Number
Beschreibung

Patient Number

Datentyp

integer

Alias
UMLS CUI [1]
C1830427
Patient Initials
Beschreibung

Patient Initials

Datentyp

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Beschreibung

Visit Date

Datentyp

date

Alias
UMLS CUI [1]
C1320303
INCLUSION/EXCLUSION CRITERIA
Beschreibung

INCLUSION/EXCLUSION CRITERIA

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C0680251
Patient has a total score > 15 on the RLS Rating Scale at baseline
Beschreibung

RLS Rating Scale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
Signs of secondary RLS (e.g. renal failure (end-stage renal disease), iron deficient anemia), or pregnancy at baseline.
Beschreibung

secondary RLS

Datentyp

boolean

Alias
UMLS CUI [1]
C1536279
Patient suffers from augmentation and/or end of dose rebound at baseline.
Beschreibung

Augmentation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0473305
UMLS CUI [1,2]
C0454417
Patient has clinically significant abnormal laboratory, ECG or physical examination findings not resolved by the time of the baseline examinations.
Beschreibung

abnormal

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205161
UMLS CUI [1,2]
C0438215
UMLS CUI [1,3]
C0522055
UMLS CUI [1,4]
C0031809
Patient is taking any medication known to induce drowsiness, affect RLS or sleep (the minimum discontinuation period is generally 5 half lives or 7 consecutive nights medication free, prior to baseline, whichever is the longer period).
Beschreibung

medication

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0037313
UMLS CUI [1,3]
C0013144
Patient has a diastolic blood pressure > 110mmHg or < 50mmHg OR systolic blood pressure > 180mmHg or < 90mmHg at baseline.
Beschreibung

blood pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0005823
Patient has participated in any clinical drug or device trial in the 3 months prior to the baseline visit.
Beschreibung

trial

Datentyp

boolean

Alias
UMLS CUI [1]
C2347449
Patient has withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, cimetidine, HRT) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Patients already on these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrolment through to the follow-up visit at end of study.
Beschreibung

hormone replacement therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0207509
UMLS CUI [1,2]
C0282402
RLS RATING SCALES
Beschreibung

RLS RATING SCALES

Alias
UMLS CUI-1
C0450973
UMLS CUI-2
C0035258
Mark the patient’s total score for all 10 items
Beschreibung

RLS Rating Scale

Datentyp

integer

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
If this score is not more than 15 exclude the patient
Beschreibung

RLS Rating Scale

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0681889
UMLS CUI [1,2]
C0035258
PATIENT RATED SCALES
Beschreibung

PATIENT RATED SCALES

Alias
UMLS CUI-1
C0030705
UMLS CUI-2
C0450973
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
Beschreibung

Patient related scales

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0450973
VITAL SIGNS
Beschreibung

VITAL SIGNS

Alias
UMLS CUI-1
C0518766
Pulse
Beschreibung

(after 5 minutes sitting)

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0232117
beats/min
Sitting Blood Pressure systolic
Beschreibung

(after 5 minutes sitting)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0580946
UMLS CUI [1,2]
C0871470
Sitting Blood Pressure diastolic
Beschreibung

(after 5 minutes sitting)

Datentyp

integer

Alias
UMLS CUI [1,1]
C0580946
UMLS CUI [1,2]
C0428883
CONCOMITANT MEDICATION
Beschreibung

CONCOMITANT MEDICATION

Alias
UMLS CUI-1
C2347852
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
Beschreibung

Concomitant Medication

Datentyp

boolean

Alias
UMLS CUI [1]
C2347852
MEDICAL PROCEDURES
Beschreibung

MEDICAL PROCEDURES

Alias
UMLS CUI-1
C0199171
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
Beschreibung

Medical Procedures

Datentyp

boolean

Alias
UMLS CUI [1]
C0199171
BASELINE SIGNS AND SYMPTOMS
Beschreibung

BASELINE SIGNS AND SYMPTOMS

Alias
UMLS CUI-1
C0037088
UMLS CUI-2
C1442488
UMLS CUI-3
C0877248
UMLS CUI-4
C0011900
Please mark this box if no baseline events occurred prior to randomisation into study.
Beschreibung

no baseline event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C1442488
Baseline Event
Beschreibung

Baseline Event

Datentyp

text

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

Onset Date and Time

Datentyp

date

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

End Date and Time

Datentyp

date

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

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

Datentyp

integer

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1442488
Event Course
Beschreibung

Event Course

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C1442488
Event Course - Number of episodes
Beschreibung

Event Course

Datentyp

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0750729
UMLS CUI [1,3]
C1442488
UMLS CUI [1,4]
C0332189
Intensity
Beschreibung

Maximum

Datentyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C1442488
Relationship to study procedures performed prior to randomisation
Beschreibung

Relationship to study procedures performed prior to randomisation

Datentyp

integer

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

If ‘Yes’, record details in Prior and ConcomitantMedication section and/or Health Care Resource Utilisation section if appropriate.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0087111
Was patient withdrawn due to this specific event?
Beschreibung

Patient withdrawn due to event

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0877248
BASELINE EMPLOYMENT STATUS
Beschreibung

BASELINE EMPLOYMENT STATUS

Alias
UMLS CUI-1
C0242271
UMLS CUI-2
C1442488
Full time employment
Beschreibung

Full time employment

Datentyp

boolean

Alias
UMLS CUI [1]
C0682295
Part-time employment
Beschreibung

Part-time employment

Datentyp

boolean

Alias
UMLS CUI [1]
C0682294
Part-time employment: list approximate hours per week:
Beschreibung

Part-time employment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0682294
UMLS CUI [1,2]
C2584953
Volunteer/Unpaid work
Beschreibung

Volunteer/Unpaid work

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2367294
UMLS CUI [1,2]
C0557361
Volunteer/Unpaid work
Beschreibung

Volunteer/Unpaid work

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2367294
UMLS CUI [1,2]
C0557361
UMLS CUI [1,3]
C2584953
Unemployed due to RLS
Beschreibung

Unemployed due to RLS

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0041674
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0035258
Unemployed due to other (NON-RLS) disability
Beschreibung

Unemployed due to other (NON-RLS) disability

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0041674
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0231170
Unemployed for other reason
Beschreibung

Unemployed for other reason

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0041674
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C3840932
Retired
Beschreibung

Retired

Datentyp

boolean

Alias
UMLS CUI [1]
C0035345
Date of retirement
Beschreibung

Retired

Datentyp

date

Alias
UMLS CUI [1,1]
C0035345
UMLS CUI [1,2]
C0011008
Homemaker
Beschreibung

Homemaker

Datentyp

boolean

Alias
UMLS CUI [1]
C0555052
If patient is employed (full-time, part-time or an unpaid volunteer) or seeking work answer question 2 2. Please mark the one box below which best describes the category of the patient's occupation: (International Standard Classification of Occupations, ISCO-88 COM)
Beschreibung

employment

Datentyp

integer

Alias
UMLS CUI [1]
C0014003
CLINICAL GLOBAL IMPRESSION
Beschreibung

CLINICAL GLOBAL IMPRESSION

Alias
UMLS CUI-1
C3639708
CLINICAL GLOBAL IMPRESSION
Beschreibung

CLINICAL GLOBAL IMPRESSION

Datentyp

boolean

Alias
UMLS CUI [1]
C3639708
RAMOS RANDOMISATION AND DISPENSING
Beschreibung

RAMOS RANDOMISATION AND DISPENSING

Alias
UMLS CUI-1
C0034656
UMLS CUI-2
C0947323
UMLS CUI-3
C0947323
Randomisation number
Beschreibung

Randomisation number

Datentyp

text

Alias
UMLS CUI [1,1]
C0034656
UMLS CUI [1,2]
C0237753
Container number
Beschreibung

Container number

Datentyp

text

Alias
UMLS CUI [1,1]
C0180098
UMLS CUI [1,2]
C0013227
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Ähnliche Modelle

Baseline GSK Ropinirole in Patients Suffering from Restless Legs Syndrome 101468/190

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
General Information
C1508263 (UMLS CUI-1)
C1955348 (UMLS CUI-2)
C0035258 (UMLS CUI-3)
Centre Number
Item
Centre Number
integer
C0600091 (UMLS CUI [1,1])
C0019994 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
INCLUSION/EXCLUSION CRITERIA
C1512693 (UMLS CUI-1)
C0680251 (UMLS CUI-2)
RLS Rating Scale
Item
Patient has a total score > 15 on the RLS Rating Scale at baseline
boolean
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
secondary RLS
Item
Signs of secondary RLS (e.g. renal failure (end-stage renal disease), iron deficient anemia), or pregnancy at baseline.
boolean
C1536279 (UMLS CUI [1])
Augmentation
Item
Patient suffers from augmentation and/or end of dose rebound at baseline.
boolean
C0473305 (UMLS CUI [1,1])
C0454417 (UMLS CUI [1,2])
abnormal
Item
Patient has clinically significant abnormal laboratory, ECG or physical examination findings not resolved by the time of the baseline examinations.
boolean
C0205161 (UMLS CUI [1,1])
C0438215 (UMLS CUI [1,2])
C0522055 (UMLS CUI [1,3])
C0031809 (UMLS CUI [1,4])
medication
Item
Patient is taking any medication known to induce drowsiness, affect RLS or sleep (the minimum discontinuation period is generally 5 half lives or 7 consecutive nights medication free, prior to baseline, whichever is the longer period).
boolean
C0013227 (UMLS CUI [1,1])
C0037313 (UMLS CUI [1,2])
C0013144 (UMLS CUI [1,3])
blood pressure
Item
Patient has a diastolic blood pressure > 110mmHg or < 50mmHg OR systolic blood pressure > 180mmHg or < 90mmHg at baseline.
boolean
C0005823 (UMLS CUI [1])
trial
Item
Patient has participated in any clinical drug or device trial in the 3 months prior to the baseline visit.
boolean
C2347449 (UMLS CUI [1])
hormone replacement therapy
Item
Patient has withdrawal, introduction, or change in dose of hormone replacement therapy (HRT) and/or any drug known to substantially inhibit CYP1A2 (e.g., ciprofloxacin, cimetidine, HRT) or induce CYP1A2 (e.g. tobacco, omeprazole) within 7 days prior to enrolment. Patients already on these agents may be enrolled but must remain on stable doses of the agent from 7 days prior to enrolment through to the follow-up visit at end of study.
boolean
C0207509 (UMLS CUI [1,1])
C0282402 (UMLS CUI [1,2])
Item Group
RLS RATING SCALES
C0450973 (UMLS CUI-1)
C0035258 (UMLS CUI-2)
RLS Rating Scale
Item
Mark the patient’s total score for all 10 items
integer
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
RLS Rating Scale
Item
If this score is not more than 15 exclude the patient
boolean
C0681889 (UMLS CUI [1,1])
C0035258 (UMLS CUI [1,2])
Item Group
PATIENT RATED SCALES
C0030705 (UMLS CUI-1)
C0450973 (UMLS CUI-2)
Patient related scales
Item
If the patient is eligible to continue in the study please continue the assessments for this visit as stated below: Remove the appropriate scales from the Patient Reported Outcomes Questionnaire Book and ask the patient to complete them in the following order: • RLS Quality of Life Questionnaire • SF36 Health Status Survey • Medical Outcome Study Sleep Scale • Work Productivity and Activity Impairment Questionnaire
boolean
C0030705 (UMLS CUI [1,1])
C0450973 (UMLS CUI [1,2])
Item Group
VITAL SIGNS
C0518766 (UMLS CUI-1)
pulse
Item
Pulse
integer
C0232117 (UMLS CUI [1])
Sitting Blood Pressure systolic
Item
Sitting Blood Pressure systolic
integer
C0580946 (UMLS CUI [1,1])
C0871470 (UMLS CUI [1,2])
Sitting Blood Pressure diastolic
Item
Sitting Blood Pressure diastolic
integer
C0580946 (UMLS CUI [1,1])
C0428883 (UMLS CUI [1,2])
Item Group
CONCOMITANT MEDICATION
C2347852 (UMLS CUI-1)
Concomitant Medication
Item
Please record any changes in concomitant medication since the last visit in the Concomitant Medication section at the back of this book.
boolean
C2347852 (UMLS CUI [1])
Item Group
MEDICAL PROCEDURES
C0199171 (UMLS CUI-1)
Medical Procedures
Item
Please record any medical procedures performed since the last visit in the Medical Procedures section at the back of this book.
boolean
C0199171 (UMLS CUI [1])
Item Group
BASELINE SIGNS AND SYMPTOMS
C0037088 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C0011900 (UMLS CUI-4)
no baseline event
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 Event
Item
Baseline Event
text
C0559546 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Onset Date and Time
Item
Onset Date and Time
date
C2981441 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
End Date and Time
Item
End Date and Time
date
C2981425 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Item
Outcome
integer
C1705586 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Resolved (1)
CL Item
Ongoing (2)
CL Item
Died (3)
Item
Event Course
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
Event Course
Code List
Event Course
CL Item
Intermittent (1)
CL Item
Consistent (2)
Event Course
Item
Event Course - Number of episodes
integer
C0877248 (UMLS CUI [1,1])
C0750729 (UMLS CUI [1,2])
C1442488 (UMLS CUI [1,3])
C0332189 (UMLS CUI [1,4])
Item
Intensity
integer
C0518690 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Relationship to study procedures performed prior to randomisation
integer
C0877248 (UMLS CUI [1,1])
C1510821 (UMLS CUI [1,2])
Relationship to study procedures performed prior to randomisation
Code List
Relationship to study procedures performed prior to randomisation
CL Item
Related (1)
CL Item
Possibly related (2)
CL Item
Probably related (3)
CL Item
Unrelated (4)
Corrective Therapy
Item
Corrective Therapy
boolean
C0877248 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Patient withdrawn due to event
Item
Was patient withdrawn due to this specific event?
boolean
C0422727 (UMLS CUI [1,1])
C0877248 (UMLS CUI [1,2])
Item Group
BASELINE EMPLOYMENT STATUS
C0242271 (UMLS CUI-1)
C1442488 (UMLS CUI-2)
Full time employment
Item
Full time employment
boolean
C0682295 (UMLS CUI [1])
Part-time employment
Item
Part-time employment
boolean
C0682294 (UMLS CUI [1])
Part-time employment
Item
Part-time employment: list approximate hours per week:
boolean
C0682294 (UMLS CUI [1,1])
C2584953 (UMLS CUI [1,2])
Volunteer/Unpaid work
Item
Volunteer/Unpaid work
boolean
C2367294 (UMLS CUI [1,1])
C0557361 (UMLS CUI [1,2])
Volunteer/Unpaid work
Item
Volunteer/Unpaid work
boolean
C2367294 (UMLS CUI [1,1])
C0557361 (UMLS CUI [1,2])
C2584953 (UMLS CUI [1,3])
Unemployed due to RLS
Item
Unemployed due to RLS
boolean
C0041674 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0035258 (UMLS CUI [1,3])
Unemployed due to other (NON-RLS) disability
Item
Unemployed due to other (NON-RLS) disability
boolean
C0041674 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0231170 (UMLS CUI [1,3])
Unemployed for other reason
Item
Unemployed for other reason
boolean
C0041674 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C3840932 (UMLS CUI [1,3])
Retired
Item
Retired
boolean
C0035345 (UMLS CUI [1])
Retired
Item
Date of retirement
date
C0035345 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Homemaker
Item
Homemaker
boolean
C0555052 (UMLS CUI [1])
Item
If patient is employed (full-time, part-time or an unpaid volunteer) or seeking work answer question 2 2. Please mark the one box below which best describes the category of the patient's occupation: (International Standard Classification of Occupations, ISCO-88 COM)
integer
C0014003 (UMLS CUI [1])
employment
Code List
If patient is employed (full-time, part-time or an unpaid volunteer) or seeking work answer question 2 2. Please mark the one box below which best describes the category of the patient's occupation: (International Standard Classification of Occupations, ISCO-88 COM)
CL Item
Legislator, senior official or manager (e.g. specialist managers, directors and chief executives) (1)
CL Item
Professional (e.g. teaching, legal, science and health professionals) (2)
CL Item
Technician or associate professional (computer associates, nurses/midwives, ship & aircraft controllers, police inspectors, finance & sales) (3)
CL Item
Clerk (e.g. secretaries, cashiers and other office clerks) (4)
CL Item
Service worker or shop and market sales worker (e.g. housekeeping and restaurant services, shop salesperson & demonstrators, and models) (5)
CL Item
Skilled agricultural or fishery worker (e.g. animal/crop producers, market gardeners, fishery workers, hunters and trappers) (6)
CL Item
Craft and related trades worker (e.g. miners, builders, blacksmiths, potters, glass-makers, textile workers) (7)
CL Item
Plant and machine operator or assembler (e.g. metal processing plant operators, food and related products machine operators) (8)
CL Item
Military (9)
Item Group
CLINICAL GLOBAL IMPRESSION
C3639708 (UMLS CUI-1)
CLINICAL GLOBAL IMPRESSION
Item
CLINICAL GLOBAL IMPRESSION
boolean
C3639708 (UMLS CUI [1])
Item Group
RAMOS RANDOMISATION AND DISPENSING
C0034656 (UMLS CUI-1)
C0947323 (UMLS CUI-2)
C0947323 (UMLS CUI-3)
Randomisation number
Item
Randomisation number
text
C0034656 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Container number
Item
Container number
text
C0180098 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
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