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TIME AND EVENTS TABLE Ropinirole Case Report Form GSK

1 forms  
TIME AND EVENTS TABLE
Description

TIME AND EVENTS TABLE

Assessments
Description

Assessments

Data type

integer

Alias
UMLS CUI [1]
C0220825
IRLSSG diagnostic criteria
Description

IRLSSG diagnostic criteria

Data type

integer

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C2348561
Inclusion/exclusion criteria
Description

Inclusion/exclusion criteria

Data type

integer

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
Subject demography
Description

Subject demography

Data type

integer

Alias
UMLS CUI [1]
C0011298
RLS history
Description

RLS history

Data type

integer

Alias
UMLS CUI [1]
C0035258
Orthostatic blood pressure and heart rate
Description

Orthostatic blood pressure and heart rate

Data type

integer

Alias
UMLS CUI [1]
C1095971
Weight
Description

Weight

Data type

integer

Alias
UMLS CUI [1]
C0220825
Height
Description

Height

Data type

integer

Alias
UMLS CUI [1]
C0005890
ECG
Description

ECG

Data type

integer

Alias
UMLS CUI [1]
C0220825
Medical/surgical history
Description

Medical/surgical history

Data type

integer

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0455610
Physical examination
Description

Physical examination

Data type

integer

Alias
UMLS CUI [1]
C0031809
Laboratory evaluation
Description

Laboratory evaluation

Data type

integer

Alias
UMLS CUI [1]
C0022885
Prior/concomitant medication
Description

Prior/concomitant medication

Data type

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013227
Pregnancy test
Description

Pregnancy test

Data type

integer

Alias
UMLS CUI [1]
C0032976
Dispense Subject Symptom Diary
Description

Dispense Subject Symptom Diary

Data type

integer

Alias
UMLS CUI [1]
C2216446
Dispense Actigraphy device
Description

Dispense Actigraphy device

Data type

integer

Alias
UMLS CUI [1]
C1171301
IRLS Rating Scale
Description

IRLS Rating Scale

Data type

integer

Alias
UMLS CUI [1]
C0681889
CGI Scales (Improvement & Severity)
Description

CGI Scales (Improvement & Severity)

Data type

integer

Alias
UMLS CUI [1]
C3639708
Insomnia Severity Index
Description

Insomnia Severity Index

Data type

integer

Alias
UMLS CUI [1]
C0917801
Written informed consent
Description

Written informed consent

Data type

integer

Alias
UMLS CUI [1]
C0021430
Dispense Patient Global Improvement Scale (PGI) Forms
Description

Dispense Patient Global Improvement Scale (PGI) Forms

Data type

integer

Alias
UMLS CUI [1,1]
C2986411
UMLS CUI [1,2]
C0349674
Patient satisfaction question
Description

Patient satisfaction question

Data type

integer

Alias
UMLS CUI [1]
C3476649
Quality of Life Questionnaire
Description

Quality of Life Questionnaire

Data type

integer

Alias
UMLS CUI [1]
C0451149
MOS Sleep Scale
Description

MOS Sleep Scale

Data type

integer

Alias
UMLS CUI [1]
C3697468
Profile of Mood States (POMS)
Description

Profile of Mood States (POMS)

Data type

integer

Alias
UMLS CUI [1]
C0451394
Hospital Anxiety and Depression Scale (HADS)
Description

Hospital Anxiety and Depression Scale (HADS)

Data type

integer

Alias
UMLS CUI [1]
C3539657
Adverse events
Description

Adverse events

Data type

integer

Alias
UMLS CUI [1]
C0877248
Subject randomization
Description

Subject randomization

Data type

integer

Alias
UMLS CUI [1]
C0034656
Pharmacogenomics sample
Description

Pharmacogenomics sample

Data type

integer

Alias
UMLS CUI [1]
C1138555
Study conclusion form
Description

Study conclusion form

Data type

integer

Alias
UMLS CUI [1]
C1707478
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TIME AND EVENTS TABLE Ropinirole Case Report Form GSK

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
TIME AND EVENTS TABLE
Item
Assessments
integer
C0220825 (UMLS CUI [1])
Assessments
Code List
Assessments
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
IRLSSG diagnostic criteria
integer
C0035258 (UMLS CUI [1,1])
C2348561 (UMLS CUI [1,2])
Assessments
Code List
IRLSSG diagnostic criteria
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Inclusion/exclusion criteria
integer
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Assessments
Code List
Inclusion/exclusion criteria
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Subject demography
integer
C0011298 (UMLS CUI [1])
Assessments
Code List
Subject demography
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
RLS history
integer
C0035258 (UMLS CUI [1])
Assessments
Code List
RLS history
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Orthostatic blood pressure and heart rate
integer
C1095971 (UMLS CUI [1])
Assessments
Code List
Orthostatic blood pressure and heart rate
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Weight
integer
C0220825 (UMLS CUI [1])
Assessments
Code List
Weight
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Height
integer
C0005890 (UMLS CUI [1])
Assessments
Code List
Height
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
ECG
integer
C0220825 (UMLS CUI [1])
Assessments
Code List
ECG
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Medical/surgical history
integer
C0262926 (UMLS CUI [1,1])
C0455610 (UMLS CUI [1,2])
Assessments
Code List
Medical/surgical history
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Physical examination
integer
C0031809 (UMLS CUI [1])
Assessments
Code List
Physical examination
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Laboratory evaluation
integer
C0022885 (UMLS CUI [1])
Assessments
Code List
Laboratory evaluation
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Prior/concomitant medication
integer
C2347852 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Assessments
Code List
Prior/concomitant medication
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Pregnancy test
integer
C0032976 (UMLS CUI [1])
Assessments
Code List
Pregnancy test
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Dispense Subject Symptom Diary
integer
C2216446 (UMLS CUI [1])
Assessments
Code List
Dispense Subject Symptom Diary
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Dispense Actigraphy device
integer
C1171301 (UMLS CUI [1])
Assessments
Code List
Dispense Actigraphy device
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
IRLS Rating Scale
integer
C0681889 (UMLS CUI [1])
Assessments
Code List
IRLS Rating Scale
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
CGI Scales (Improvement & Severity)
integer
C3639708 (UMLS CUI [1])
Assessments
Code List
CGI Scales (Improvement & Severity)
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Insomnia Severity Index
integer
C0917801 (UMLS CUI [1])
Assessments
Code List
Insomnia Severity Index
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Written informed consent
integer
C0021430 (UMLS CUI [1])
Assessments
Code List
Written informed consent
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Dispense Patient Global Improvement Scale (PGI) Forms
integer
C2986411 (UMLS CUI [1,1])
C0349674 (UMLS CUI [1,2])
Assessments
Code List
Dispense Patient Global Improvement Scale (PGI) Forms
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Patient satisfaction question
integer
C3476649 (UMLS CUI [1])
Assessments
Code List
Patient satisfaction question
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Quality of Life Questionnaire
integer
C0451149 (UMLS CUI [1])
Assessments
Code List
Quality of Life Questionnaire
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
MOS Sleep Scale
integer
C3697468 (UMLS CUI [1])
Assessments
Code List
MOS Sleep Scale
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Profile of Mood States (POMS)
integer
C0451394 (UMLS CUI [1])
Assessments
Code List
Profile of Mood States (POMS)
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Hospital Anxiety and Depression Scale (HADS)
integer
C3539657 (UMLS CUI [1])
Assessments
Code List
Hospital Anxiety and Depression Scale (HADS)
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Adverse events
integer
C0877248 (UMLS CUI [1])
Assessments
Code List
Adverse events
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Subject randomization
integer
C0034656 (UMLS CUI [1])
Assessments
Code List
Subject randomization
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Pharmacogenomics sample
integer
C1138555 (UMLS CUI [1])
Assessments
Code List
Pharmacogenomics sample
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
Item
Study conclusion form
integer
C1707478 (UMLS CUI [1])
Assessments
Code List
Study conclusion form
CL Item
Screening (1)
C1409616 (UMLS CUI-1)
(Comment:en)
CL Item
Baseline (2)
C1442488 (UMLS CUI-1)
(Comment:en)
CL Item
12 Week Double-Blind Treatment Phase (3)
C0013072 (UMLS CUI-1)
C0814495 (UMLS CUI-2)
(Comment:en)
CL Item
Early withdrawal (4)
C2349954 (UMLS CUI-1)
(Comment:en)
CL Item
Follow Up (5)
C1522577 (UMLS CUI-1)
(Comment:en)
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