ID

40422

Descripción

Study ID: 111314 Clinical Study ID: 111314 Study Title: A first-time-in-human, three-part, placebo-controlled, dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00857883 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK1521498 or placebo Study Indication: Obesity

Palabras clave

Versiones (1)
  1. 19/4/20 19/4/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

19 de abril de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK1521498 in healthy subjects NCT00857883

Inglés

Neurological Exam; Ptosis & Nystagmus Assessment; Sensory Stimulus VAS Session

1 formularios  
Administrative
Descripción

Administrative

Alias
UMLS CUI-1
C1320722
Study
Descripción

Study

Tipo de datos

text

Alias
UMLS CUI [1]
C2603343
Subject
Descripción

Subject

Tipo de datos

text

Alias
UMLS CUI [1]
C0681850
Collected by
Descripción

Collected by

Tipo de datos

text

Alias
UMLS CUI [1]
C3244127
Subject Number
Descripción

Subject Number

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Study Phase
Descripción

Study Phase

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0205390
UMLS CUI [1,2]
C2603343
Session
Descripción

Session

Tipo de datos

text

Alias
UMLS CUI [1]
C1883017
Neurological Exam
Descripción

Neurological Exam

Alias
UMLS CUI-1
C0027853
Neurological Exam - Physical Date
Descripción

Neurological Exam - Physical Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0011008
Neurological Exam - Time
Descripción

Neurological Exam - Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0040223
Neurological Exam - Day
Descripción

Neurological Exam - Day

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0439228
Neurological Exam - Hour
Descripción

Neurological Exam - Hour

Tipo de datos

integer

Unidades de medida
  • h
Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0439227
h
Neurological Exam - Min
Descripción

Neurological Exam - Min

Tipo de datos

integer

Unidades de medida
  • min
Alias
UMLS CUI [1,1]
C0027853
UMLS CUI [1,2]
C0439232
min
Was a neurological exam required?
Descripción

Was a neurological exam required?

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027853
Ptosis & Nystagmus Assessment
Descripción

Ptosis & Nystagmus Assessment

Alias
UMLS CUI-1
C0028738
UMLS CUI-2
C1516048
UMLS CUI-4
C0033377
UMLS CUI-5
C1516048
Ptosis & Nystagmus Assessment - Physical Date
Descripción

Ptosis & Nystagmus Assessment - Physical Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C0028738
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0011008
UMLS CUI [2,1]
C0033377
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0011008
Ptosis & Nystagmus Assessment - Time
Descripción

Ptosis & Nystagmus Assessment - Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C0028738
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0040223
UMLS CUI [2,1]
C0033377
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0040223
Ptosis & Nystagmus Assessment - Day
Descripción

Ptosis & Nystagmus Assessment - Day

Tipo de datos

text

Alias
UMLS CUI [1,1]
C0028738
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0439228
UMLS CUI [2,1]
C0033377
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0439228
Ptosis & Nystagmus Assessment - Hour
Descripción

Ptosis & Nystagmus Assessment - Hour

Tipo de datos

integer

Unidades de medida
  • h
Alias
UMLS CUI [1,1]
C0028738
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0439227
UMLS CUI [2,1]
C0033377
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0439227
h
Ptosis & Nystagmus Assessment - Min
Descripción

Ptosis & Nystagmus Assessment - Min

Tipo de datos

integer

Unidades de medida
  • min
Alias
UMLS CUI [1,1]
C0028738
UMLS CUI [1,2]
C1516048
UMLS CUI [1,3]
C0439232
UMLS CUI [2,1]
C0033377
UMLS CUI [2,2]
C1516048
UMLS CUI [2,3]
C0439232
min
Ptosis Test Normal?
Descripción

Ptosis Test Normal?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0033377
UMLS CUI [1,2]
C1096215
Nystagmus Test Normal?
Descripción

Nystagmus Test Normal?

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0028738
UMLS CUI [1,2]
C1096215
Sensory Stimulus VAS Session 1
Descripción

Sensory Stimulus VAS Session 1

Alias
UMLS CUI-1
C1522640
UMLS CUI-2
C3536884
Sensory Stimulus VAS Session 1 - Physical Date
Descripción

Sensory Stimulus VAS Session 1 - Physical Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0011008
Sensory Stimulus VAS Session 1 - Time
Descripción

Sensory Stimulus VAS Session 1 - Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0040223
Sensory Stimulus VAS Session 1 - Day
Descripción

Sensory Stimulus VAS Session 1 - Day

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0439228
Sensory Stimulus VAS Session 1 - Hour
Descripción

Sensory Stimulus VAS Session 1 - Hour

Tipo de datos

integer

Unidades de medida
  • h
Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0439227
h
Sensory Stimulus VAS Session 1 - Min
Descripción

Sensory Stimulus VAS Session 1 - Min

Tipo de datos

integer

Unidades de medida
  • min
Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0439232
min
Sensory Stimulus VAS Session 1
Descripción

Sensory Stimulus VAS Session 1

Alias
UMLS CUI-1
C1522640
UMLS CUI-2
C3536884
Sensory Stimulus VAS Session 1 Prompt
Descripción

Sensory Stimulus VAS Session 1 Prompt

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C1602245
Sensory Stimulus VAS Session 1 - Assessment Details
Descripción

Sensory Stimulus VAS Session 1 - Assessment Details

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C1522508
UMLS CUI [1,4]
C0220825
Sensory Stimulus VAS Session 2
Descripción

Sensory Stimulus VAS Session 2

Alias
UMLS CUI-1
C1522640
UMLS CUI-2
C3536884
Sensory Stimulus VAS Session 2 - Physical Date
Descripción

Sensory Stimulus VAS Session 2 - Physical Date

Tipo de datos

date

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0011008
Sensory Stimulus VAS Session 2 - Time
Descripción

Sensory Stimulus VAS Session 2 - Time

Tipo de datos

time

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0040223
Sensory Stimulus VAS Session 2 - Day
Descripción

Sensory Stimulus VAS Session 2 - Day

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0439228
Sensory Stimulus VAS Session 2 - Hour
Descripción

Sensory Stimulus VAS Session 2 - Hour

Tipo de datos

integer

Unidades de medida
  • h
Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0439227
h
Sensory Stimulus VAS Session 2 - Min
Descripción

Sensory Stimulus VAS Session 2 - Min

Tipo de datos

integer

Unidades de medida
  • min
Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C0439232
min
Sensory Stimulus VAS Session 2
Descripción

Sensory Stimulus VAS Session 2

Alias
UMLS CUI-1
C1522640
UMLS CUI-2
C3536884
Sensory Stimulus VAS Session 2 Prompt
Descripción

Sensory Stimulus VAS Session 2 Prompt

Tipo de datos

integer

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C1602245
Sensory Stimulus VAS Session 2 - Assessment Details
Descripción

Sensory Stimulus VAS Session 2 - Assessment Details

Tipo de datos

text

Alias
UMLS CUI [1,1]
C1522640
UMLS CUI [1,2]
C3536884
UMLS CUI [1,3]
C1522508
UMLS CUI [1,4]
C0220825
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Similar models

Neurological Exam; Ptosis & Nystagmus Assessment; Sensory Stimulus VAS Session

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Study
Item
Study
text
C2603343 (UMLS CUI [1])
Subject
Item
Subject
text
C0681850 (UMLS CUI [1])
Collected by
Item
Collected by
text
C3244127 (UMLS CUI [1])
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Study Phase
Item
Study Phase
text
C0205390 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
Session
Item
Session
text
C1883017 (UMLS CUI [1])
Item Group
Neurological Exam
C0027853 (UMLS CUI-1)
Neurological Exam - Physical Date
Item
Neurological Exam - Physical Date
date
C0027853 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Neurological Exam - Time
Item
Neurological Exam - Time
time
C0027853 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Neurological Exam - Day
Item
Neurological Exam - Day
text
C0027853 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Neurological Exam - Hour
Item
Neurological Exam - Hour
integer
C0027853 (UMLS CUI [1,1])
C0439227 (UMLS CUI [1,2])
Neurological Exam - Min
Item
Neurological Exam - Min
integer
C0027853 (UMLS CUI [1,1])
C0439232 (UMLS CUI [1,2])
Was a neurological exam required?
Item
Was a neurological exam required?
boolean
C0027853 (UMLS CUI [1])
Item Group
Ptosis & Nystagmus Assessment
C0028738 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
C0033377 (UMLS CUI-4)
C1516048 (UMLS CUI-5)
Ptosis & Nystagmus Assessment - Physical Date
Item
Ptosis & Nystagmus Assessment - Physical Date
date
C0028738 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0033377 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0011008 (UMLS CUI [2,3])
Ptosis & Nystagmus Assessment - Time
Item
Ptosis & Nystagmus Assessment - Time
time
C0028738 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0033377 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
Ptosis & Nystagmus Assessment - Day
Item
Ptosis & Nystagmus Assessment - Day
text
C0028738 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
C0033377 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0439228 (UMLS CUI [2,3])
Ptosis & Nystagmus Assessment - Hour
Item
Ptosis & Nystagmus Assessment - Hour
integer
C0028738 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
C0033377 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0439227 (UMLS CUI [2,3])
Ptosis & Nystagmus Assessment - Min
Item
Ptosis & Nystagmus Assessment - Min
integer
C0028738 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
C0033377 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C0439232 (UMLS CUI [2,3])
Ptosis Test Normal?
Item
Ptosis Test Normal?
boolean
C0033377 (UMLS CUI [1,1])
C1096215 (UMLS CUI [1,2])
Nystagmus Test Normal?
Item
Nystagmus Test Normal?
boolean
C0028738 (UMLS CUI [1,1])
C1096215 (UMLS CUI [1,2])
Item Group
Sensory Stimulus VAS Session 1
C1522640 (UMLS CUI-1)
C3536884 (UMLS CUI-2)
Sensory Stimulus VAS Session 1 - Physical Date
Item
Sensory Stimulus VAS Session 1 - Physical Date
date
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 1 - Time
Item
Sensory Stimulus VAS Session 1 - Time
time
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 1 - Day
Item
Sensory Stimulus VAS Session 1 - Day
text
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 1 - Hour
Item
Sensory Stimulus VAS Session 1 - Hour
integer
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 1 - Min
Item
Sensory Stimulus VAS Session 1 - Min
integer
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
Item Group
Sensory Stimulus VAS Session 1
C1522640 (UMLS CUI-1)
C3536884 (UMLS CUI-2)
Item
Sensory Stimulus VAS Session 1 Prompt
integer
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C1602245 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 1 Prompt
Code List
Sensory Stimulus VAS Session 1 Prompt
CL Item
Syringe 1 sweetness (1)
CL Item
Syringe 1 creaminess (2)
CL Item
Syringe 1 fat content (3)
CL Item
Syringe 2 sweetness (4)
CL Item
Syringe 2 creaminess (5)
CL Item
Syringe 2 fat content (6)
CL Item
Syringe 3 sweetness (7)
CL Item
Syringe 3 creaminess (8)
CL Item
Syringe 3 fat content (9)
CL Item
Syringe 4 sweetness (10)
CL Item
Syringe 4 creaminess (11)
CL Item
Syringe 4 fat content (12)
CL Item
Syringe 5 sweetness (13)
CL Item
Syringe 5 creaminess (14)
CL Item
Syringe 5 fat content (15)
CL Item
Syringe 6 sweetness (16)
CL Item
Syringe 6 creaminess (17)
CL Item
Syringe 6 fat content (18)
CL Item
Syringe 7 sweetness (19)
CL Item
Syringe 7 creaminess (20)
CL Item
Syringe 7 fat content (21)
CL Item
Syringe 8 sweetness (22)
CL Item
Syringe 8 creaminess (23)
CL Item
Syringe 8 fat content (24)
CL Item
Syringe 9 sweetness (25)
CL Item
Syringe 9 creaminess (26)
CL Item
Syringe 9 fat content (27)
CL Item
Syringe 10 sweetness (28)
CL Item
Syringe 10 creaminess (29)
CL Item
Syringe 10 fat content (30)
CL Item
Syringe 11 sweetness (31)
CL Item
Syringe 11 creaminess (32)
CL Item
Syringe 11 fat content (33)
CL Item
Syringe 12 sweetness (34)
CL Item
Syringe 12 creaminess (35)
CL Item
Syringe 12 fat content (36)
CL Item
Syringe 13 sweetness (37)
CL Item
Syringe 13 creaminess (38)
CL Item
Syringe 13 fat content (39)
CL Item
Syringe 14 sweetness (40)
CL Item
Syringe 14 creaminess (41)
CL Item
Syringe 14 fat content (42)
CL Item
Syringe 15 sweetness (43)
CL Item
Syringe 15 creaminess (44)
CL Item
Syringe 15 fat content (45)
CL Item
Syringe 16 sweetness (46)
CL Item
Syringe 16 creaminess (47)
CL Item
Syringe 16 fat content (48)
CL Item
Syringe 17 sweetness (49)
CL Item
Syringe 17 creaminess (50)
CL Item
Syringe 17 fat content (51)
CL Item
Syringe 18 sweetness (52)
CL Item
Syringe 18 creaminess (53)
CL Item
Syringe 18 fat content (54)
CL Item
Syringe 19 sweetness (55)
CL Item
Syringe 19 creaminess (56)
CL Item
Syringe 19 fat content (57)
CL Item
Syringe 20 sweetness (58)
CL Item
Syringe 20 creaminess (59)
CL Item
Syringe 20 fat content (60)
Sensory Stimulus VAS Session 1 - Assessment Details
Item
Sensory Stimulus VAS Session 1 - Assessment Details
text
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,4])
Item Group
Sensory Stimulus VAS Session 2
C1522640 (UMLS CUI-1)
C3536884 (UMLS CUI-2)
Sensory Stimulus VAS Session 2 - Physical Date
Item
Sensory Stimulus VAS Session 2 - Physical Date
date
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 2 - Time
Item
Sensory Stimulus VAS Session 2 - Time
time
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 2 - Day
Item
Sensory Stimulus VAS Session 2 - Day
text
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 2 - Hour
Item
Sensory Stimulus VAS Session 2 - Hour
integer
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0439227 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 2 - Min
Item
Sensory Stimulus VAS Session 2 - Min
integer
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C0439232 (UMLS CUI [1,3])
Item Group
Sensory Stimulus VAS Session 2
C1522640 (UMLS CUI-1)
C3536884 (UMLS CUI-2)
Item
Sensory Stimulus VAS Session 2 Prompt
integer
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C1602245 (UMLS CUI [1,3])
Sensory Stimulus VAS Session 2 Prompt
Code List
Sensory Stimulus VAS Session 2 Prompt
CL Item
Syringe 1 sweetness (1)
CL Item
Syringe 1 creaminess (2)
CL Item
Syringe 1 fat content (3)
CL Item
Syringe 2 sweetness (4)
CL Item
Syringe 2 creaminess (5)
CL Item
Syringe 2 fat content (6)
CL Item
Syringe 3 sweetness (7)
CL Item
Syringe 3 creaminess (8)
CL Item
Syringe 3 fat content (9)
CL Item
Syringe 4 sweetness (10)
CL Item
Syringe 4 creaminess (11)
CL Item
Syringe 4 fat content (12)
CL Item
Syringe 5 sweetness (13)
CL Item
Syringe 5 creaminess (14)
CL Item
Syringe 5 fat content (15)
CL Item
Syringe 6 sweetness (16)
CL Item
Syringe 6 creaminess (17)
CL Item
Syringe 6 fat content (18)
CL Item
Syringe 7 sweetness (19)
CL Item
Syringe 7 creaminess (20)
CL Item
Syringe 7 fat content (21)
CL Item
Syringe 8 sweetness (22)
CL Item
Syringe 8 creaminess (23)
CL Item
Syringe 8 fat content (24)
CL Item
Syringe 9 sweetness (25)
CL Item
Syringe 9 creaminess (26)
CL Item
Syringe 9 fat content (27)
CL Item
Syringe 10 sweetness (28)
CL Item
Syringe 10 creaminess (29)
CL Item
Syringe 10 fat content (30)
CL Item
Syringe 11 sweetness (31)
CL Item
Syringe 11 creaminess (32)
CL Item
Syringe 11 fat content (33)
CL Item
Syringe 12 sweetness (34)
CL Item
Syringe 12 creaminess (35)
CL Item
Syringe 12 fat content (36)
CL Item
Syringe 13 sweetness (37)
CL Item
Syringe 13 creaminess (38)
CL Item
Syringe 13 fat content (39)
CL Item
Syringe 14 sweetness (40)
CL Item
Syringe 14 creaminess (41)
CL Item
Syringe 14 fat content (42)
CL Item
Syringe 15 sweetness (43)
CL Item
Syringe 15 creaminess (44)
CL Item
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Sensory Stimulus VAS Session 2 - Assessment Details
Item
Sensory Stimulus VAS Session 2 - Assessment Details
text
C1522640 (UMLS CUI [1,1])
C3536884 (UMLS CUI [1,2])
C1522508 (UMLS CUI [1,3])
C0220825 (UMLS CUI [1,4])
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