ID

44707

Description

Study ID: 111634 Clinical Study ID: 111634 Study Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6, 10, 14 weeks) primary immunization course in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants followed by a booster vaccination at 9-10 months of age. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00829010 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Pneumococcal vaccine GSK1024850A Trade Name: Tritanrix-HepB/Hib, Rotarix Study Indication: Infections, Streptococcal This phase III trial studies the immunogenicity, safety and reactogenicity of a 10-valent pneumococcal conjugate vaccine in three groups of infants that differ by HIV status: HIV-positive infants, HIV-negative infants who are exposed to the virus (by their HIV-positive mother), and HIV-negative infants who are not exposed. The study consists of Screening at 4-8 weeks of age (only for HIV-positive and HIV-exposed infants without HIV-DNA test) and 10 subsequent Visits over a period of 23 months. There are five study cohorts: HIV-positive and HIV-exposed participants receive the vaccine at Visits 1, 2, 3 (i.e. 6, 10 and 14 weeks of life; primary course) and 5 (9-10 months of age; booster), whereas HIV-negative, unexposed infants are randomly assigned to one of three vaccination schedules: the aforementioned schedule consisting of the primary course and the booster, or the 3-dose primary course only without the booster vaccination, or a different primary course consisting of only two vaccinations at Visits 1 and 3 (6 and 14 weeks of age) followed by a booster at Visit 5 (9-10 months). Visit 1 is scheduled at 6-10 weeks of life. The interval between Visits 1 and 2, 2 and 3, as well as 3 and 4 has to be 28-42 days each. Visit 5 then takes place at 9-10 months of age. The interval between Visit 5 and 6 again has to be 28-42 days. Visit 7 is scheduled at 12-13 months of age, Visit 8 at 15-18 months, Visit 9 at 16-19 months, and the final Visit 10 is performed when the subjects are 24-27 months old. This form is used for recording clinical symptoms of HIV as well as staging the disease, is only applicable to HIV-positive infants and is to be filled in at Visits 1, 5, 8 and 10.

Keywords

Versions (2)
  1. 8/28/19 8/28/19 -
  2. 9/27/21 9/27/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY-NC 3.0
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10-valent pneumococcal vaccine in HIV-positive, HIV-exposed and HIV-negative infants - NCT00829010

English

WHO Clinical Staging of HIV

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Type
Description

Visit Type

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Clinical HIV staging not applicable
Description

HIV staging is not applicable for HIV-negative, HIV-exposed subjects. If not applicable, skip the rest of this form.

Data type

boolean

Alias
UMLS CUI [1,1]
C1976611
UMLS CUI [1,2]
C0205210
UMLS CUI [1,3]
C1272460
Clinical HIV staging
Description

Clinical HIV staging

Alias
UMLS CUI-1
C1976611
UMLS CUI-2
C0205210
What is the clinical staging of the HIV disease for the subject?
Description

Select one, and then select all symptoms/illnesses in the respective item group which apply.

Data type

integer

Alias
UMLS CUI [1,1]
C1976611
UMLS CUI [1,2]
C0205210
HIV infection WHO clinical stage 1
Description

HIV infection WHO clinical stage 1

Alias
UMLS CUI-1
C1536038
Asymptomatic
Description

Asymptomatic

Data type

boolean

Alias
UMLS CUI [1]
C0231221
Persistent generalized lymphadenopathy
Description

Persistent generalized lymphadenopathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C0205322
UMLS CUI [1,3]
C0205246
HIV infection WHO clinical stage 2
Description

HIV infection WHO clinical stage 2

Alias
UMLS CUI-1
C1536039
Unexplained moderate weight loss
Description

under 10 per cent of presumed or measured body weight. Unexplained refers to where the condition is not explained by other conditions

Data type

boolean

Alias
UMLS CUI [1,1]
C1828173
UMLS CUI [1,2]
C1319166
Recurrent upper respiratory tract infections (sinusitis, tonsillitis, otitis media, pharyngitis)
Description

Recurrent upper respiratory tract infections (sinusitis, tonsillitis, otitis media, pharyngitis)

Data type

boolean

Alias
UMLS CUI [1,1]
C0041912
UMLS CUI [1,2]
C2945760
UMLS CUI [2]
C0029882
UMLS CUI [3]
C0037199
UMLS CUI [4]
C0040425
UMLS CUI [5]
C0031350
Herpes zoster
Description

Herpes zoster

Data type

boolean

Alias
UMLS CUI [1]
C0019360
Angular cheilitis
Description

Angular cheilitis

Data type

boolean

Alias
UMLS CUI [1]
C0221237
Recurrent oral ulceration
Description

Recurrent oral ulceration

Data type

boolean

Alias
UMLS CUI [1,1]
C2945760
UMLS CUI [1,2]
C0149745
Papular pruritic eruptions
Description

Papular pruritic eruptions

Data type

boolean

Alias
UMLS CUI [1,1]
C1519353
UMLS CUI [1,2]
C0033774
UMLS CUI [1,3]
C0037274
Seborrhoeic dermatitis
Description

Seborrhoeic dermatitis

Data type

boolean

Alias
UMLS CUI [1]
C0036508
Fungal nail infection
Description

Fungal nail infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0026946
UMLS CUI [1,2]
C0343026
HIV infection WHO clinical stage 3
Description

HIV infection WHO clinical stage 3

Alias
UMLS CUI-1
C1536040
Unexplained severe weight loss
Description

over 10 per cent of presumed or measured body weight Unexplained refers to where the condition is not explained by other conditions

Data type

boolean

Alias
UMLS CUI [1,1]
C1828173
UMLS CUI [1,2]
C1319166
Unexplained chronic diarrhoea
Description

for longer than one month Unexplained refers to where the condition is not explained by other conditions

Data type

boolean

Alias
UMLS CUI [1,1]
C0011991
UMLS CUI [1,2]
C4288071
UMLS CUI [1,3]
C0008679
Unexplained persistent fever
Description

intermittent or constant for longer than one month. Unexplained refers to where the condition is not explained by other conditions

Data type

boolean

Alias
UMLS CUI [1,1]
C4288071
UMLS CUI [1,2]
C0476474
Persistent oral candidiasis
Description

Persistent oral candidiasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0006849
UMLS CUI [1,2]
C0205322
oral hairy leukoplakia
Description

changed from "leukopenia" (in the original file) to "leukoplakia" (in this electronic document) due to context

Data type

boolean

Alias
UMLS CUI [1]
C1304455
Pulmonary tuberculosis (current)
Description

Pulmonary tuberculosis (current)

Data type

boolean

Alias
UMLS CUI [1,1]
C0041327
UMLS CUI [1,2]
C0521116
Severe bacterial infections (e.g. pneumonia, empyema, pyomyositis, bone or joint infection, meningitis, bacteraemia, severe pelvic inflammatory disease)
Description

Severe bacterial infections (e.g. pneumonia, empyema, pyomyositis, bone or joint infection, meningitis, bacteraemia, severe pelvic inflammatory disease)

Data type

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C1292730
UMLS CUI [2]
C0032285
UMLS CUI [3]
C0014009
UMLS CUI [4]
C1704275
UMLS CUI [5]
C0029443
UMLS CUI [6]
C0157749
UMLS CUI [7]
C0025289
UMLS CUI [8]
C0004610
UMLS CUI [9,1]
C0242172
UMLS CUI [9,2]
C1292730
Acute necrotizing ulcerative stomatitis, gingivitis or periodontitis
Description

Acute necrotizing ulcerative stomatitis, gingivitis or periodontitis

Data type

boolean

Alias
UMLS CUI [1,1]
C0017575
UMLS CUI [1,2]
C0205178
UMLS CUI [2,1]
C0205178
UMLS CUI [2,2]
C0392103
UMLS CUI [3]
C0472840
Unexplained anaemia, neutropenia and/or chronic thrombocytopenia
Description

Unexplained refers to where the condition is not explained by other conditions. Cut-offs: anaemia: below 8 g/dl neutropenia: below 0.5 x 10^9/l thrombocytopenia: below 50 x 10^9/l

Data type

boolean

Alias
UMLS CUI [1,1]
C4288071
UMLS CUI [1,2]
C0027947
UMLS CUI [2,1]
C4288071
UMLS CUI [2,2]
C0205191
UMLS CUI [2,3]
C0040034
UMLS CUI [3,1]
C4288071
UMLS CUI [3,2]
C0002871
HIV infection WHO clinical stage 4
Description

HIV infection WHO clinical stage 4

Alias
UMLS CUI-1
C1536041
HIV wasting syndrome
Description

HIV wasting syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0343755
Pneumocystis pneumonia
Description

Pneumocystis pneumonia

Data type

boolean

Alias
UMLS CUI [1]
C1535939
Recurrent bacterial pneumonia
Description

Recurrent bacterial pneumonia

Data type

boolean

Alias
UMLS CUI [1,1]
C1844383
UMLS CUI [1,2]
C0032285
Chronic herpes simplex infection
Description

orolabial, genital or anorectal of more than one month’s duration or visceral at any site

Data type

boolean

Alias
UMLS CUI [1,1]
C0019348
UMLS CUI [1,2]
C0008679
Oesophageal candidiasis (or candidiasis of trachea, bronchi or lungs)
Description

Oesophageal candidiasis (or candidiasis of trachea, bronchi or lungs)

Data type

boolean

Alias
UMLS CUI [1]
C0239295
UMLS CUI [2]
C0343862
UMLS CUI [3]
C1536274
UMLS CUI [4]
C0153251
Extrapulmonary tuberculosis
Description

Extrapulmonary tuberculosis

Data type

boolean

Alias
UMLS CUI [1]
C0679362
Kaposi sarcoma
Description

Kaposi sarcoma

Data type

boolean

Alias
UMLS CUI [1]
C0036220
Cytomegalovirus infection
Description

retinitis or infection of other organs

Data type

boolean

Alias
UMLS CUI [1]
C0010823
Central nervous system toxoplasmosis
Description

Central nervous system toxoplasmosis

Data type

boolean

Alias
UMLS CUI [1]
C0751629
HIV encephalopathy
Description

HIV encephalopathy

Data type

boolean

Alias
UMLS CUI [1]
C0206019
Extrapulmonary cryptococcosis including meningitis
Description

Extrapulmonary cryptococcosis including meningitis

Data type

boolean

Alias
UMLS CUI [1]
C0343890
UMLS CUI [2]
C1394255
Disseminated non-tuberculous mycobacteria infection
Description

Disseminated non-tuberculous mycobacteria infection

Data type

boolean

Alias
UMLS CUI [1,1]
C0205221
UMLS CUI [1,2]
C1265234
UMLS CUI [1,3]
C0009450
Progressive multifocal leukoencephalopathy
Description

Progressive multifocal leukoencephalopathy

Data type

boolean

Alias
UMLS CUI [1]
C0023524
Chronic cryptosporidiosis
Description

Chronic cryptosporidiosis

Data type

boolean

Alias
UMLS CUI [1]
C0239055
Chronic isosporiasis
Description

Chronic isosporiasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0311386
UMLS CUI [1,2]
C0205191
Disseminated mycosis (coccidiomycosis or histoplasmosis)
Description

Disseminated mycosis (coccidiomycosis or histoplasmosis)

Data type

boolean

Alias
UMLS CUI [1]
C0553576
UMLS CUI [2,1]
C0262426
UMLS CUI [2,2]
C0205221
UMLS CUI [3,1]
C0019655
UMLS CUI [3,2]
C0205221
Recurrent septicemia (including non-typhoidal Salmonella)
Description

Recurrent septicemia (including non-typhoidal Salmonella)

Data type

boolean

Alias
UMLS CUI [1,1]
C0349437
UMLS CUI [1,2]
C2945607
UMLS CUI [2,1]
C0036690
UMLS CUI [2,2]
C2945760
Lymphoma (cerebral or B cell non-Hodgkin)
Description

Lymphoma (cerebral or B cell non-Hodgkin)

Data type

boolean

Alias
UMLS CUI [1]
C0240803
UMLS CUI [2,1]
C0024305
UMLS CUI [2,2]
C0079731
Invasive cervical carcinoma
Description

Invasive cervical carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1334177
Atypical disseminated leishmaniasis
Description

Atypical disseminated leishmaniasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0860236
UMLS CUI [1,2]
C0205182
Symptomatic HIV-associated nephropathy or HIV-associated cardiomyopathy
Description

Symptomatic HIV-associated nephropathy or HIV-associated cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1,1]
C0078911
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C2721728
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Similar models

WHO Clinical Staging of HIV

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Clinical Trial Subject Unique Identifier
Item
Subject Identifier
integer
C2348585 (UMLS CUI [1])
Item
Visit Type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Visit Type
Code List
Visit Type
CL Item
Visit 1 (1)
CL Item
Visit 5 (5)
CL Item
Visit 8 (8)
CL Item
Visit 10 (10)
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Clinical HIV staging not applicable
Item
Clinical HIV staging not applicable
boolean
C1976611 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C1272460 (UMLS CUI [1,3])
Item Group
Clinical HIV staging
C1976611 (UMLS CUI-1)
C0205210 (UMLS CUI-2)
Item
What is the clinical staging of the HIV disease for the subject?
integer
C1976611 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
clinical staging of the HIV disease
Code List
What is the clinical staging of the HIV disease for the subject?
CL Item
Clinical stage 1 (1)
CL Item
Clinical stage 2 (2)
CL Item
Clinical stage 3 (3)
CL Item
Clinical stage 4 (4)
Item Group
HIV infection WHO clinical stage 1
C1536038 (UMLS CUI-1)
Asymptomatic
Item
Asymptomatic
boolean
C0231221 (UMLS CUI [1])
Persistent generalized lymphadenopathy
Item
Persistent generalized lymphadenopathy
boolean
C0497156 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0205246 (UMLS CUI [1,3])
Item Group
HIV infection WHO clinical stage 2
C1536039 (UMLS CUI-1)
Unexplained moderate weight loss
Item
Unexplained moderate weight loss
boolean
C1828173 (UMLS CUI [1,1])
C1319166 (UMLS CUI [1,2])
Recurrent upper respiratory tract infections (sinusitis, tonsillitis, otitis media, pharyngitis)
Item
Recurrent upper respiratory tract infections (sinusitis, tonsillitis, otitis media, pharyngitis)
boolean
C0041912 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C0029882 (UMLS CUI [2])
C0037199 (UMLS CUI [3])
C0040425 (UMLS CUI [4])
C0031350 (UMLS CUI [5])
Herpes zoster
Item
Herpes zoster
boolean
C0019360 (UMLS CUI [1])
Angular cheilitis
Item
Angular cheilitis
boolean
C0221237 (UMLS CUI [1])
Recurrent oral ulceration
Item
Recurrent oral ulceration
boolean
C2945760 (UMLS CUI [1,1])
C0149745 (UMLS CUI [1,2])
Papular pruritic eruptions
Item
Papular pruritic eruptions
boolean
C1519353 (UMLS CUI [1,1])
C0033774 (UMLS CUI [1,2])
C0037274 (UMLS CUI [1,3])
Seborrhoeic dermatitis
Item
Seborrhoeic dermatitis
boolean
C0036508 (UMLS CUI [1])
Fungal nail infection
Item
Fungal nail infection
boolean
C0026946 (UMLS CUI [1,1])
C0343026 (UMLS CUI [1,2])
Item Group
HIV infection WHO clinical stage 3
C1536040 (UMLS CUI-1)
Unexplained severe weight loss
Item
Unexplained severe weight loss
boolean
C1828173 (UMLS CUI [1,1])
C1319166 (UMLS CUI [1,2])
Unexplained chronic diarrhoea
Item
Unexplained chronic diarrhoea
boolean
C0011991 (UMLS CUI [1,1])
C4288071 (UMLS CUI [1,2])
C0008679 (UMLS CUI [1,3])
Unexplaineda persistent fever
Item
Unexplained persistent fever
boolean
C4288071 (UMLS CUI [1,1])
C0476474 (UMLS CUI [1,2])
Persistent oral candidiasis
Item
Persistent oral candidiasis
boolean
C0006849 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
oral hairy leukoplakia
Item
oral hairy leukoplakia
boolean
C1304455 (UMLS CUI [1])
Pulmonary tuberculosis (current)
Item
Pulmonary tuberculosis (current)
boolean
C0041327 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Severe bacterial infections (e.g. pneumonia, empyema, pyomyositis, bone or joint infection, meningitis, bacteraemia, severe pelvic inflammatory disease)
Item
Severe bacterial infections (e.g. pneumonia, empyema, pyomyositis, bone or joint infection, meningitis, bacteraemia, severe pelvic inflammatory disease)
boolean
C0004623 (UMLS CUI [1,1])
C1292730 (UMLS CUI [1,2])
C0032285 (UMLS CUI [2])
C0014009 (UMLS CUI [3])
C1704275 (UMLS CUI [4])
C0029443 (UMLS CUI [5])
C0157749 (UMLS CUI [6])
C0025289 (UMLS CUI [7])
C0004610 (UMLS CUI [8])
C0242172 (UMLS CUI [9,1])
C1292730 (UMLS CUI [9,2])
Acute necrotizing ulcerative stomatitis, gingivitis or periodontitis
Item
Acute necrotizing ulcerative stomatitis, gingivitis or periodontitis
boolean
C0017575 (UMLS CUI [1,1])
C0205178 (UMLS CUI [1,2])
C0205178 (UMLS CUI [2,1])
C0392103 (UMLS CUI [2,2])
C0472840 (UMLS CUI [3])
Unexplained anaemia, neutropenia and/or chronic thrombocytopenia
Item
Unexplained anaemia, neutropenia and/or chronic thrombocytopenia
boolean
C4288071 (UMLS CUI [1,1])
C0027947 (UMLS CUI [1,2])
C4288071 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0040034 (UMLS CUI [2,3])
C4288071 (UMLS CUI [3,1])
C0002871 (UMLS CUI [3,2])
Item Group
HIV infection WHO clinical stage 4
C1536041 (UMLS CUI-1)
HIV wasting syndrome
Item
HIV wasting syndrome
boolean
C0343755 (UMLS CUI [1])
Pneumocystis pneumonia
Item
Pneumocystis pneumonia
boolean
C1535939 (UMLS CUI [1])
Recurrent bacterial pneumonia
Item
Recurrent bacterial pneumonia
boolean
C1844383 (UMLS CUI [1,1])
C0032285 (UMLS CUI [1,2])
Chronic herpes simplex infection
Item
Chronic herpes simplex infection
boolean
C0019348 (UMLS CUI [1,1])
C0008679 (UMLS CUI [1,2])
Oesophageal candidiasis (or candidiasis of trachea, bronchi or lungs)
Item
Oesophageal candidiasis (or candidiasis of trachea, bronchi or lungs)
boolean
C0239295 (UMLS CUI [1])
C0343862 (UMLS CUI [2])
C1536274 (UMLS CUI [3])
C0153251 (UMLS CUI [4])
Extrapulmonary tuberculosis
Item
Extrapulmonary tuberculosis
boolean
C0679362 (UMLS CUI [1])
Kaposi sarcoma
Item
Kaposi sarcoma
boolean
C0036220 (UMLS CUI [1])
Cytomegalovirus infection
Item
Cytomegalovirus infection
boolean
C0010823 (UMLS CUI [1])
Central nervous system toxoplasmosis
Item
Central nervous system toxoplasmosis
boolean
C0751629 (UMLS CUI [1])
HIV encephalopathy
Item
HIV encephalopathy
boolean
C0206019 (UMLS CUI [1])
Extrapulmonary cryptococcosis including meningitis
Item
Extrapulmonary cryptococcosis including meningitis
boolean
C0343890 (UMLS CUI [1])
C1394255 (UMLS CUI [2])
Disseminated non-tuberculous mycobacteria infection
Item
Disseminated non-tuberculous mycobacteria infection
boolean
C0205221 (UMLS CUI [1,1])
C1265234 (UMLS CUI [1,2])
C0009450 (UMLS CUI [1,3])
Progressive multifocal leukoencephalopathy
Item
Progressive multifocal leukoencephalopathy
boolean
C0023524 (UMLS CUI [1])
Chronic cryptosporidiosis
Item
Chronic cryptosporidiosis
boolean
C0239055 (UMLS CUI [1])
Chronic isosporiasis
Item
Chronic isosporiasis
boolean
C0311386 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Disseminated mycosis (coccidiomycosis or histoplasmosis)
Item
Disseminated mycosis (coccidiomycosis or histoplasmosis)
boolean
C0553576 (UMLS CUI [1])
C0262426 (UMLS CUI [2,1])
C0205221 (UMLS CUI [2,2])
C0019655 (UMLS CUI [3,1])
C0205221 (UMLS CUI [3,2])
Recurrent septicemia (including non-typhoidal Salmonella)
Item
Recurrent septicemia (including non-typhoidal Salmonella)
boolean
C0349437 (UMLS CUI [1,1])
C2945607 (UMLS CUI [1,2])
C0036690 (UMLS CUI [2,1])
C2945760 (UMLS CUI [2,2])
Lymphoma (cerebral or B cell non-Hodgkin)
Item
Lymphoma (cerebral or B cell non-Hodgkin)
boolean
C0240803 (UMLS CUI [1])
C0024305 (UMLS CUI [2,1])
C0079731 (UMLS CUI [2,2])
Invasive cervical carcinoma
Item
Invasive cervical carcinoma
boolean
C1334177 (UMLS CUI [1])
Atypical disseminated leishmaniasis
Item
Atypical disseminated leishmaniasis
boolean
C0860236 (UMLS CUI [1,1])
C0205182 (UMLS CUI [1,2])
Symptomatic HIV-associated nephropathy or HIV-associated cardiomyopathy
Item
Symptomatic HIV-associated nephropathy or HIV-associated cardiomyopathy
boolean
C0078911 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C2721728 (UMLS CUI [2])
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