ID

42909

Description

Study ID: 100013 Clinical Study ID: RRL100013 A 12-Week, Double-Blind, Placebo-Controlled, Twice-Daily Dosing Study to Assess the Efficacy and Safety of Ropinirole in Patients Suffering from Restless Legs Syndrome (RLS) Requiring Extended Treatment Coverage

Keywords

  1. 8/26/17 8/26/17 -
  2. 9/17/21 9/17/21 -
Copyright Holder

gsk

Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY-NC 3.0

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TIME AND EVENTS TABLE Ropinirole Case Report Form GSK RRL100013

TIME AND EVENTS TABLE Ropinirole Case Report Form GSK

Zeitplan
Description

Zeitplan

Bewertung
Description

Assessments

Data type

integer

Alias
UMLS CUI [1]
C0220825
IRLSSG diagnostische Kriterien
Description

IRLSSG diagnostic criteria

Data type

integer

Alias
UMLS CUI [1,1]
C0035258
UMLS CUI [1,2]
C2348561
Einschlusskriterien & Ausschlusskriterien
Description

Inclusion/exclusion criteria

Data type

integer

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C0680251
Patientendaten
Description

Subject demography

Data type

integer

Alias
UMLS CUI [1]
C0011298
RSL Anamnese
Description

RLS history

Data type

integer

Alias
UMLS CUI [1]
C0035258
RR
Description

Orthostatic blood pressure and heart rate

Data type

integer

Alias
UMLS CUI [1]
C1095971
Gewicht
Description

Weight

Data type

integer

Alias
UMLS CUI [1]
C0220825
Größe
Description

Height

Data type

integer

Alias
UMLS CUI [1]
C0005890
EKG
Description

ECG

Data type

integer

Alias
UMLS CUI [1]
C0220825
Anamnese
Description

Medical/surgical history

Data type

integer

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0455610
Körperliche Untersuchung
Description

Physical examination

Data type

integer

Alias
UMLS CUI [1]
C0031809
Labor
Description

Laboratory evaluation

Data type

integer

Alias
UMLS CUI [1]
C0022885
Medikamente
Description

Prior/concomitant medication

Data type

integer

Alias
UMLS CUI [1,1]
C2347852
UMLS CUI [1,2]
C0013227
Schwangerschaftstest
Description

Pregnancy test

Data type

integer

Alias
UMLS CUI [1]
C0032976
Symptom Tagebuch
Description

Dispense Subject Symptom Diary

Data type

integer

Alias
UMLS CUI [1]
C2216446
Aktigraphie
Description

Dispense Actigraphy device

Data type

integer

Alias
UMLS CUI [1]
C1171301
IRLS Beurteilungsskala
Description

IRLS Rating Scale

Data type

integer

Alias
UMLS CUI [1]
C0681889
CGI Beurteilung
Description

CGI Scales (Improvement & Severity)

Data type

integer

Alias
UMLS CUI [1]
C3639708
Insomnie Schweregradindex
Description

Insomnia Severity Index

Data type

integer

Alias
UMLS CUI [1]
C0917801
schriftliche Einwilligungserklärung
Description

Written informed consent

Data type

integer

Alias
UMLS CUI [1]
C0021430
Verbesserung
Description

Dispense Patient Global Improvement Scale (PGI) Forms

Data type

integer

Alias
UMLS CUI [1,1]
C2986411
UMLS CUI [1,2]
C0349674
Zufriedenheitsfragebogen
Description

Patient satisfaction question

Data type

integer

Alias
UMLS CUI [1]
C3476649
Lebensqualität Fragebogen
Description

Quality of Life Questionnaire

Data type

integer

Alias
UMLS CUI [1]
C0451149
Pittsburgh Schlafskala
Description

MOS Sleep Scale

Data type

integer

Alias
UMLS CUI [1]
C3697468
Gemütszustand
Description

Profile of Mood States (POMS)

Data type

integer

Alias
UMLS CUI [1]
C0451394
Krankenhaus Angstskala
Description

Hospital Anxiety and Depression Scale (HADS)

Data type

integer

Alias
UMLS CUI [1]
C3539657
unerwünschtem Ereignis
Description

Adverse events

Data type

integer

Alias
UMLS CUI [1]
C0877248
Randomisierung
Description

Subject randomization

Data type

integer

Alias
UMLS CUI [1]
C0034656
Pharmacogenomics
Description

Pharmacogenomics sample

Data type

integer

Alias
UMLS CUI [1]
C1138555
Schlussfolgerung
Description

Study conclusion form

Data type

integer

Alias
UMLS CUI [1]
C1707478

Similar models

TIME AND EVENTS TABLE Ropinirole Case Report Form GSK

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Zeitplan
Item
Bewertung
integer
C0220825 (UMLS CUI [1])
Code List
Bewertung
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 diagnostische Kriterien
integer
C0035258 (UMLS CUI [1,1])
C2348561 (UMLS CUI [1,2])
Code List
IRLSSG diagnostische Kriterien
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
Einschlusskriterien & Ausschlusskriterien
integer
C1512693 (UMLS CUI [1,1])
C0680251 (UMLS CUI [1,2])
Code List
Einschlusskriterien & Ausschlusskriterien
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
Patientendaten
integer
C0011298 (UMLS CUI [1])
Code List
Patientendaten
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
RSL Anamnese
integer
C0035258 (UMLS CUI [1])
Code List
RSL Anamnese
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
RR
integer
C1095971 (UMLS CUI [1])
Code List
RR
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
Gewicht
integer
C0220825 (UMLS CUI [1])
Code List
Gewicht
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
Größe
integer
C0005890 (UMLS CUI [1])
Code List
Größe
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
EKG
integer
C0220825 (UMLS CUI [1])
Code List
EKG
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
Anamnese
integer
C0262926 (UMLS CUI [1,1])
C0455610 (UMLS CUI [1,2])
Code List
Anamnese
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
Körperliche Untersuchung
integer
C0031809 (UMLS CUI [1])
Code List
Körperliche Untersuchung
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
Labor
integer
C0022885 (UMLS CUI [1])
Code List
Labor
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
Medikamente
integer
C2347852 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Code List
Medikamente
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
Schwangerschaftstest
integer
C0032976 (UMLS CUI [1])
Code List
Schwangerschaftstest
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
Symptom Tagebuch
integer
C2216446 (UMLS CUI [1])
Code List
Symptom Tagebuch
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
Aktigraphie
integer
C1171301 (UMLS CUI [1])
Code List
Aktigraphie
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 Beurteilungsskala
integer
C0681889 (UMLS CUI [1])
Code List
IRLS Beurteilungsskala
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 Beurteilung
integer
C3639708 (UMLS CUI [1])
Code List
CGI Beurteilung
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
Insomnie Schweregradindex
integer
C0917801 (UMLS CUI [1])
Code List
Insomnie Schweregradindex
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
schriftliche Einwilligungserklärung
integer
C0021430 (UMLS CUI [1])
Code List
schriftliche Einwilligungserklärung
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
Verbesserung
integer
C2986411 (UMLS CUI [1,1])
C0349674 (UMLS CUI [1,2])
Code List
Verbesserung
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
Zufriedenheitsfragebogen
integer
C3476649 (UMLS CUI [1])
Code List
Zufriedenheitsfragebogen
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
Lebensqualität Fragebogen
integer
C0451149 (UMLS CUI [1])
Code List
Lebensqualität Fragebogen
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
Pittsburgh Schlafskala
integer
C3697468 (UMLS CUI [1])
Code List
Pittsburgh Schlafskala
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
Gemütszustand
integer
C0451394 (UMLS CUI [1])
Code List
Gemütszustand
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
Krankenhaus Angstskala
integer
C3539657 (UMLS CUI [1])
Code List
Krankenhaus Angstskala
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
unerwünschtem Ereignis
integer
C0877248 (UMLS CUI [1])
Code List
unerwünschtem Ereignis
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
Randomisierung
integer
C0034656 (UMLS CUI [1])
Code List
Randomisierung
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
integer
C1138555 (UMLS CUI [1])
Code List
Pharmacogenomics
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
Schlussfolgerung
integer
C1707478 (UMLS CUI [1])
Code List
Schlussfolgerung
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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