ID

29519

Beschreibung

Study ID: 104385 Clinical Study ID: RES104385 Study Title: A randomised double-blind two-period crossover study to investigate the effect of treatment with repeat doses of a PPAR gamma agonist on the allergen-induced late asthmatic response in subjects with mild asthma compared with repeat doses of placebo Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00318630 https://clinicaltrials.gov/ct2/show/NCT00318630 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia XR,Avandia; Rosiglitazone XR,Avandia XR,Avandia Study Indication: Asthma This ODM-file contains Screening Part 2 - Medical conditions incl. child-bearing potential.

Link

https://clinicaltrials.gov/ct2/show/NCT00318630

Stichworte

Versionen (2)
  1. 05.04.18 05.04.18 - Sarah Riepenhausen
  2. 05.04.18 05.04.18 - Sarah Riepenhausen
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

5. April 2018

DOI

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Lizenz

Creative Commons BY-NC 3.0
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GSK Influence of PPAR gamma agonist vs. Placebo on allergen-induced late asthmatic response NCT00318630

Englisch

Screening 2 - Medical Conditions

1 Formulare  
Child-bearing Potential
Beschreibung

Child-bearing Potential

Alias
UMLS CUI-1
C3831118
Child-bearing potential: pick one.
Beschreibung

Complete for Female Subjects only. Post-menopausal: > 6 months without a menstrual period. sterile: Pre-menopausal women who cannot conceive children. (This category includes women who have become sterile through surgical procedures such as tubal ligation. Do not include post-menopausal women in this category.). Potentially able to bear children: Women of child-bearing age who are not sterile. Note: If the subject is sterile and is not of child-bearing age, then ‘post-menopausal’ will be the best choice and should be ticked. If the subject is sterile and does not know if she is post-menopausal and is less than 62 years of age, then she is of child-bearing age and ‘sterile’ should be ticked.

Datentyp

integer

Alias
UMLS CUI [1]
C1960468
Pregnancy Test - Date sample Taken
Beschreibung

Complete for Female Subjects only.

Datentyp

date

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C0011008
Pregnancy test results
Beschreibung

Complete for Female Subjects only.

Datentyp

text

Alias
UMLS CUI [1,1]
C0032976
UMLS CUI [1,2]
C1274040
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Height
Beschreibung

Height

Datentyp

integer

Maßeinheiten
  • cm
Alias
UMLS CUI [1]
C0005890
cm
Weight
Beschreibung

Weight

Datentyp

float

Maßeinheiten
  • kg
Alias
UMLS CUI [1]
C0005910
kg
Body mass index
Beschreibung

Body mass index

Datentyp

float

Maßeinheiten
  • kg/m2
Alias
UMLS CUI [1]
C1305855
kg/m2
Vital Signs
Beschreibung

Vital Signs

Alias
UMLS CUI-1
C0518766
Date of Vital Signs Measurement
Beschreibung

Date of Vital Signs Measurement

Datentyp

date

Alias
UMLS CUI [1]
C2826644
Planned relative Time
Beschreibung

The subject should be in the supine position for at least 5 minutes before and during the recording. At least three consecutive readings more than 1 minute apart will be recorded.

Datentyp

text

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0439564
Actual time
Beschreibung

Hr:Min (00:00 - 23:59)

Datentyp

time

Alias
UMLS CUI [1,1]
C0518766
UMLS CUI [1,2]
C0040223
Systolic Blood pressure (supine)
Beschreibung

The subject should be in the supine position for at least 5 minutes before and during the recording. At least three consecutive readings more than 1 minute apart will be recorded.

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0871470
UMLS CUI [1,2]
C0038846
mmHg
Diastolic Blood pressure (supine)
Beschreibung

The subject should be in the supine position for at least 5 minutes before and during the recording. At least three consecutive readings more than 1 minute apart will be recorded.

Datentyp

integer

Maßeinheiten
  • mmHg
Alias
UMLS CUI [1,1]
C0428883
UMLS CUI [1,2]
C0038846
mmHg
Heart rate
Beschreibung

The subject should be in the supine position for at least 5 minutes before and during the recording. At least three consecutive readings more than 1 minute apart will be recorded.

Datentyp

integer

Maßeinheiten
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Pedal Oedema
Beschreibung

Pedal Oedema

Alias
UMLS CUI-1
C0574002
Date of Assessment
Beschreibung

Date of Assessment

Datentyp

date

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C0574002
Time of Assessment
Beschreibung

Hr:Min 00:00-23:59

Datentyp

time

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0574002
Pick one.
Beschreibung

Press firmly with thumb anterior to the ankle until further pressure produces no greater indentation. Visually estimate depth of pit and record the Estimated Depth of Indentation below. Note: Use the same ankle throughout the study.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0205125
Pick the appropriate box below to indicate which ankle was assessed at this visit:
Beschreibung

Side Ankle

Datentyp

integer

Alias
UMLS CUI [1,1]
C0574002
UMLS CUI [1,2]
C0441987
Medical conditions
Beschreibung

Medical conditions

Alias
UMLS CUI-1
C3899485
UMLS CUI-3
C0262926
Diagnosis
Beschreibung

Only in the absence of a diagnosis, record the signs and symptoms on separate lines. Please mark if current or past condition in the associated item.

Datentyp

text

Alias
UMLS CUI [1]
C3899485
UMLS CUI [2]
C0262926
Time of Medical Condition
Beschreibung

CURRENT MEDICAL CONDITIONS Conditions from which the subject is currently suffering, regardless of how long they have been present. If the subject has had a recurring condition that is not present at the time of the assessment, it can be classed as current if, in the Investigator’s opinion it is likely to recur during the study. PAST MEDICAL CONDITIONS Conditions from which the subject has suffered in the past, but are no longer present. A past condition may have stopped as recently as the day prior to being assessed.

Datentyp

integer

Alias
UMLS CUI [1]
C3899485
UMLS CUI [2]
C0262926
Duration of Asthma
Beschreibung

Duration of Asthma

Alias
UMLS CUI-1
C0004096
UMLS CUI-2
C0449238
Pick one box only
Beschreibung

Duration of Asthma

Datentyp

integer

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0449238
Physical examination
Beschreibung

Physical examination

Alias
UMLS CUI-1
C0031809
Date of Assessment
Beschreibung

Date of Assessment

Datentyp

date

Alias
UMLS CUI [1]
C2985720
Hair and skin
Beschreibung

Indicate current physical findings by ticking the appropriate box below and if ABNORMAL, describe concisely (following item).

Datentyp

text

Alias
UMLS CUI [1,1]
C0018494
UMLS CUI [1,2]
C0558035
Hair and Skin: if abnormal, describe concisely
Beschreibung

if ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/)

Datentyp

text

Alias
UMLS CUI [1,1]
C0018494
UMLS CUI [1,2]
C0558035
UMLS CUI [1,3]
C1704258
Lymph nodes
Beschreibung

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item).

Datentyp

text

Alias
UMLS CUI [1]
C0024204
Lymph nodes: if abnormal, describe concisely
Beschreibung

if ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/)

Datentyp

text

Alias
UMLS CUI [1,1]
C0024204
UMLS CUI [1,2]
C1704258
Eyes
Beschreibung

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item).

Datentyp

text

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C0031809
Eyes: if abnormal, describe concisely
Beschreibung

if ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/)

Datentyp

text

Alias
UMLS CUI [1,1]
C0015392
UMLS CUI [1,2]
C1704258
Ears, nose and throat
Beschreibung

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item).

Datentyp

text

Alias
UMLS CUI [1]
C0278350
Ears, nose and throat: if abnormal, describe concisely.
Beschreibung

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datentyp

text

Alias
UMLS CUI [1,1]
C0278350
UMLS CUI [1,2]
C1704258
Breasts
Beschreibung

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Datentyp

text

Alias
UMLS CUI [1]
C0199850
Breasts: if abnormal, describe concisely:
Beschreibung

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datentyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0006141
Respiratory
Beschreibung

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item).

Datentyp

text

Alias
UMLS CUI [1]
C0231832
Respiratory: if abnormal, describe concisely
Beschreibung

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datentyp

text

Alias
UMLS CUI [1,1]
C0035237
UMLS CUI [1,2]
C0031809
UMLS CUI [1,3]
C0205161
Cardiovascular
Beschreibung

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item).

Datentyp

text

Alias
UMLS CUI [1]
C3854344
Cardiovascular: if abnormal, describe concisely
Beschreibung

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datentyp

text

Alias
UMLS CUI [1,1]
C3854344
UMLS CUI [1,2]
C0205161
Abdomen
Beschreibung

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item).

Datentyp

text

Alias
UMLS CUI [1]
C0562238
Abdomen: if abnormal, describe concisely
Beschreibung

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datentyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0000726
Urogenital
Beschreibung

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Datentyp

text

Alias
UMLS CUI [1]
C1828035
Urogenital: if abnormal, describe concisely.
Beschreibung

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datentyp

text

Alias
UMLS CUI [1,1]
C1828035
UMLS CUI [1,2]
C0205161
Pelvic
Beschreibung

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0030797
Pelvic: if abnormal, describe concisely.
Beschreibung

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0030797
UMLS CUI [1,3]
C0205161
Rectal
Beschreibung

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Datentyp

text

Alias
UMLS CUI [1]
C0199900
Rectal: if abnormal, describe concisely.
Beschreibung

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datentyp

text

Alias
UMLS CUI [1,1]
C0199900
UMLS CUI [1,2]
C0205161
Musculoskeletal
Beschreibung

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Datentyp

text

Alias
UMLS CUI [1]
C0475091
Musculoskeletal: if abnormal, describe concisely.
Beschreibung

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datentyp

text

Alias
UMLS CUI [1,1]
C0475091
UMLS CUI [1,2]
C0205161
Neurological
Beschreibung

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Datentyp

text

Alias
UMLS CUI [1]
C0027853
Neurological: if abnormal, describe concisely.
Beschreibung

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datentyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0027853
Mental Status
Beschreibung

Indicate current physical findings by ticking the appropriate box(es) below and if ABNORMAL, describe concisely (following item)

Datentyp

text

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0278060
Mental Status: if abnormal, describe concisely.
Beschreibung

If ABNORMAL, describe concisely: different findings should be separated by either a (;) or a (/).

Datentyp

text

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C0278060
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Ähnliche Modelle

Screening 2 - Medical Conditions

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Child-bearing Potential
C3831118 (UMLS CUI-1)
Item
Child-bearing potential: pick one.
integer
C1960468 (UMLS CUI [1])
Child-bearing potential
Code List
Child-bearing potential: pick one.
CL Item
post-menopausal (2)
CL Item
sterile (of child-bearing age) (3)
CL Item
potentially able to bear children (4)
Pregnancy Test - Date
Item
Pregnancy Test - Date sample Taken
date
C0032976 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Pregnancy test results
text
C0032976 (UMLS CUI [1,1])
C1274040 (UMLS CUI [1,2])
Pregnancy test results
Code List
Pregnancy test results
CL Item
Positive (Positive)
CL Item
Negative (Negative)
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Height
Item
Height
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Body mass index
Item
Body mass index
float
C1305855 (UMLS CUI [1])
Item Group
Vital Signs
C0518766 (UMLS CUI-1)
Date of Vital Signs Measurement
Item
Date of Vital Signs Measurement
date
C2826644 (UMLS CUI [1])
Item
Planned relative Time
text
C0518766 (UMLS CUI [1,1])
C0439564 (UMLS CUI [1,2])
Planned relative Time
Code List
Planned relative Time
CL Item
Screening 1 (Screening 1)
CL Item
Screening 2 (Screening 2)
CL Item
Screening 3 (Screening 3)
CL Item
Unscheduled (Unscheduled)
Actual time
Item
Actual time
time
C0518766 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Systolic Blood pressure (supine)
Item
Systolic Blood pressure (supine)
integer
C0871470 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Diastolic Blood pressure (supine)
Item
Diastolic Blood pressure (supine)
integer
C0428883 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
Heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Pedal Oedema
C0574002 (UMLS CUI-1)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1,1])
C0574002 (UMLS CUI [1,2])
Time of Assessment
Item
Time of Assessment
time
C0011008 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0574002 (UMLS CUI [1,3])
Item
Pick one.
integer
C0574002 (UMLS CUI [1,1])
C0205125 (UMLS CUI [1,2])
Depth of Indentation
Code List
Pick one.
CL Item
< 1 mm (1)
CL Item
1-2 mm (2)
CL Item
3-5 mm (3)
CL Item
6-10 mm (4)
CL Item
> 10 mm (5)
Item
Pick the appropriate box below to indicate which ankle was assessed at this visit:
integer
C0574002 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Side Ankle
Code List
Pick the appropriate box below to indicate which ankle was assessed at this visit:
CL Item
right ankle (1)
CL Item
left ankle (2)
Item Group
Medical conditions
C3899485 (UMLS CUI-1)
C0262926 (UMLS CUI-3)
Diagnosis
Item
Diagnosis
text
C3899485 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
Item
Time of Medical Condition
integer
C3899485 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
Time of Medical Condition
Code List
Time of Medical Condition
CL Item
current (1)
CL Item
past (2)
Item Group
Duration of Asthma
C0004096 (UMLS CUI-1)
C0449238 (UMLS CUI-2)
Item
Pick one box only
integer
C0004096 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Duration of Asthma
Code List
Pick one box only
CL Item
> 6 months (1)
CL Item
>= 6 months to < 1 year (2)
CL Item
>= 1 year to < 5 years (3)
CL Item
>= 5 years to 10 years (4)
CL Item
>= 10 years (5)
Item Group
Physical examination
C0031809 (UMLS CUI-1)
Date of Assessment
Item
Date of Assessment
date
C2985720 (UMLS CUI [1])
Item
Hair and skin
text
C0018494 (UMLS CUI [1,1])
C0558035 (UMLS CUI [1,2])
Hair and skin
Code List
Hair and skin
CL Item
Normal (Normal)
CL Item
Abnormal (Abnormal)
Abnormal Hair and skin
Item
Hair and Skin: if abnormal, describe concisely
text
C0018494 (UMLS CUI [1,1])
C0558035 (UMLS CUI [1,2])
C1704258 (UMLS CUI [1,3])
Item
Lymph nodes
text
C0024204 (UMLS CUI [1])
Lymph nodes
Code List
Lymph nodes
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Abnormal Lymph nodes
Item
Lymph nodes: if abnormal, describe concisely
text
C0024204 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Eyes
text
C0015392 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
Eyes
Code List
Eyes
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Abnormal eyes
Item
Eyes: if abnormal, describe concisely
text
C0015392 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Ears, nose and throat
text
C0278350 (UMLS CUI [1])
Ears, nose and throat
Code List
Ears, nose and throat
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Abnormal Ears, nose and throat
Item
Ears, nose and throat: if abnormal, describe concisely.
text
C0278350 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
Item
Breasts
text
C0199850 (UMLS CUI [1])
Ears, nose and throat
Code List
Breasts
CL Item
normal (normal)
CL Item
abnormal (abnormal)
CL Item
not done (not done)
Abnormal Breasts
Item
Breasts: if abnormal, describe concisely:
text
C1704258 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
Item
Respiratory
text
C0231832 (UMLS CUI [1])
Ears, nose and throat
Code List
Respiratory
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Item
Respiratory: if abnormal, describe concisely
text
C0035237 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Ears, nose and throat
Code List
Respiratory: if abnormal, describe concisely
Item
Cardiovascular
text
C3854344 (UMLS CUI [1])
Ears, nose and throat
Code List
Cardiovascular
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Item
Cardiovascular: if abnormal, describe concisely
text
C3854344 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Ears, nose and throat
Code List
Cardiovascular: if abnormal, describe concisely
Item
Abdomen
text
C0562238 (UMLS CUI [1])
Ears, nose and throat
Code List
Abdomen
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Item
Abdomen: if abnormal, describe concisely
text
C1704258 (UMLS CUI [1,1])
C0000726 (UMLS CUI [1,2])
Ears, nose and throat
Code List
Abdomen: if abnormal, describe concisely
Item
Urogenital
text
C1828035 (UMLS CUI [1])
Ears, nose and throat
Code List
Urogenital
CL Item
normal (normal)
CL Item
abnormal (abnormal)
CL Item
not done (not done)
Abnormal urogenital
Item
Urogenital: if abnormal, describe concisely.
text
C1828035 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Item
Pelvic
text
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
Ears, nose and throat
Code List
Pelvic
CL Item
normal (normal)
CL Item
abnormal (abnormal)
CL Item
not done (not done)
Abnormal Pelvic
Item
Pelvic: if abnormal, describe concisely.
text
C0031809 (UMLS CUI [1,1])
C0030797 (UMLS CUI [1,2])
C0205161 (UMLS CUI [1,3])
Item
Rectal
text
C0199900 (UMLS CUI [1])
Ears, nose and throat
Code List
Rectal
CL Item
normal (normal)
CL Item
abnormal (abnormal)
CL Item
not done (not done)
Abnormal Rectal
Item
Rectal: if abnormal, describe concisely.
text
C0199900 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Item
Musculoskeletal
text
C0475091 (UMLS CUI [1])
Ears, nose and throat
Code List
Musculoskeletal
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Abnormal Musculoskeletal
Item
Musculoskeletal: if abnormal, describe concisely.
text
C0475091 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
Item
Neurological
text
C0027853 (UMLS CUI [1])
Ears, nose and throat
Code List
Neurological
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Abnormal neurological
Item
Neurological: if abnormal, describe concisely.
text
C1704258 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
Item
Mental Status
text
C0031809 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
Ears, nose and throat
Code List
Mental Status
CL Item
normal (normal)
CL Item
abnormal (abnormal)
Abnormal Mental Status
Item
Mental Status: if abnormal, describe concisely.
text
C1704258 (UMLS CUI [1,1])
C0278060 (UMLS CUI [1,2])
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