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NCT02595879 · BASELINE

Baseline characteristics

Triapine With Chemotherapy and Radiation Therapy in Treating Patients With IB2-IVA Cervical or Vaginal Cancer · Source last updated 2026-07-31

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      17
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      21
    units
    Participants
groups
  1. description
    Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up. Biospecimen Collection: Undergo collection of blood samples Brachytherapy: Undergo LDR brachytherapy Cisplatin: Given IV Computed Tomography: Undergo FDG-PET/CT External Beam Radiation Therapy: Undergo pelvic EBRT Fludeoxyglucose F-18: Undergo FDG-PET/CT High-Dose Rate Brachytherapy: Undergo HDR brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT Magnetic Resonance Imaging: Undergo MRI Pharmacological Study: Correlative studies Positron Emission Tomography: Undergo FDG-PET/CT Triapine: Given IV and PO
    id
    BG000
    title
    Triapine (100mg) + Chemoradiation)
  2. description
    Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
    id
    BG001
    title
    Triapine (150mg) + Chemoradiation)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          23.0
          upper Limit
          71.0
          value
          51.0
        2. group Id
          BG001
          lower Limit
          35.0
          upper Limit
          56.0
          value
          46.5
        3. group Id
          BG002
          lower Limit
          23.0
          upper Limit
          71.0
          value
          51.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          21
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          19
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          19
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          14
        title
        No
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown
    description
    Smoking status at time of beginning study treatment = Yes / No / Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smoking History
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          19
        title
        Cervix
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Vagina
    description
    Original site of disease upon diagnosis
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary Site
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        adenocarcinoma
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          15
        title
        squamous cell carcinoma
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        adenosquamous
    description
    structures of cells and tissues classifications
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Histology
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Stage IB
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Stage IIA
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        Stage IIB
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Stage III
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Stage IIIB
      7. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
        title
        Stage IIIC
      8. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Stage IVA
    description
    IB: \>5 mm limited to cervix II: beyond uterus, not extended to lower third of vagina or pelvic wall IIA: upper two-thirds of vagina no parametrial involvement IIB: Parametrial involvement not up to pelvic wall III: lower third of vagina and/or extends to pelvic wall and/or causes hydronephrosis or nonfunctioning kidney and/or involves pelvic and/or para-aortic lymph nodes; IIIB: Extends to pelvic wall and/or hydronephrosis or nonfunctioning kidney (unless due to other cause) IIIC: pelvic/para-aortic lymph nodes, despite tumor size/extent; lVA: adjacent pelvic organs IVB: distant organs
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stage at Diagnosis
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Stage l
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        title
        Stage ll
      3. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          11
        title
        Stage lll
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Stage lV
    description
    I: Carcinoma strictly confined to the cervix 2: Invades beyond the uterus, but has not extended onto the lower third of the vagina or to the pelvic wall 3: Involves lower third of vagina and/or extends to the pelvic wall and/or causes hydronephrosis or nonfunctioning kidney and/or involves pelvic and/or para-aortic lymph nodes 4: Extends beyond the true pelvis or involves the mucosa of the bladder or rectum
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stage
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          15
        title
        ECOG = 0
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        title
        ECOG = 1
    description
    ECOG PERFORMANCE STATUS 0 Fully active, able to carry on all pre-disease performance without restriction 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours 3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 5. Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      17
    2. group Id
      BG001
      value
      4
    3. group Id
      BG002
      value
      21
    units
    Participants
groups
  1. description
    Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up. Biospecimen Collection: Undergo collection of blood samples Brachytherapy: Undergo LDR brachytherapy Cisplatin: Given IV Computed Tomography: Undergo FDG-PET/CT External Beam Radiation Therapy: Undergo pelvic EBRT Fludeoxyglucose F-18: Undergo FDG-PET/CT High-Dose Rate Brachytherapy: Undergo HDR brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT Magnetic Resonance Imaging: Undergo MRI Pharmacological Study: Correlative studies Positron Emission Tomography: Undergo FDG-PET/CT Triapine: Given IV and PO
    id
    BG000
    title
    Triapine (100mg) + Chemoradiation)
  2. description
    Patients undergo pelvic EBRT or IMRT 5 days per week for 5 weeks (25 fractions) with a 3-day boost in week 6, and 1 or 2 applications of LDR brachytherapy in week 6 or 5 fractions of HDR brachytherapy at week 4 or 5. Patients also receive triapine IV over 120 minutes on day 1 and PO on days 2-5, 8-12, 15-19, 22-26, and 29-33 within 90 minutes after pelvic irradiation, and cisplatin IV over 60-120 minutes once weekly for 5 weeks (days 2, 9, 16, 23, and 30). Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive a 6th cycle of cisplatin IV during the parametrial boost or any make-up radiation treatment in a sixth week of external beam radiotherapy. Patients undergo the collection of blood samples on study and undergo MRI and FDG-PET/CT during follow-up.
    id
    BG001
    title
    Triapine (150mg) + Chemoradiation)
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          23.0
          upper Limit
          71.0
          value
          51.0
        2. group Id
          BG001
          lower Limit
          35.0
          upper Limit
          56.0
          value
          46.5
        3. group Id
          BG002
          lower Limit
          23.0
          upper Limit
          71.0
          value
          51.0
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          21
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          19
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          19
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          14
        title
        No
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          1
        title
        Unknown
    description
    Smoking status at time of beginning study treatment = Yes / No / Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Smoking History
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          19
        title
        Cervix
      2. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Vagina
    description
    Original site of disease upon diagnosis
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Primary Site
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          5
        title
        adenocarcinoma
      2. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          15
        title
        squamous cell carcinoma
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        adenosquamous
    description
    structures of cells and tissues classifications
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Histology
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Stage IB
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Stage IIA
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          3
        title
        Stage IIB
      5. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Stage III
      6. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Stage IIIB
      7. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          8
        title
        Stage IIIC
      8. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Stage IVA
    description
    IB: \>5 mm limited to cervix II: beyond uterus, not extended to lower third of vagina or pelvic wall IIA: upper two-thirds of vagina no parametrial involvement IIB: Parametrial involvement not up to pelvic wall III: lower third of vagina and/or extends to pelvic wall and/or causes hydronephrosis or nonfunctioning kidney and/or involves pelvic and/or para-aortic lymph nodes; IIIB: Extends to pelvic wall and/or hydronephrosis or nonfunctioning kidney (unless due to other cause) IIIC: pelvic/para-aortic lymph nodes, despite tumor size/extent; lVA: adjacent pelvic organs IVB: distant organs
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stage at Diagnosis
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          2
        title
        Stage l
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        title
        Stage ll
      3. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          11
        title
        Stage lll
      4. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        title
        Stage lV
    description
    I: Carcinoma strictly confined to the cervix 2: Invades beyond the uterus, but has not extended onto the lower third of the vagina or to the pelvic wall 3: Involves lower third of vagina and/or extends to the pelvic wall and/or causes hydronephrosis or nonfunctioning kidney and/or involves pelvic and/or para-aortic lymph nodes 4: Extends beyond the true pelvis or involves the mucosa of the bladder or rectum
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Stage
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          15
        title
        ECOG = 0
      2. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          6
        title
        ECOG = 1
    description
    ECOG PERFORMANCE STATUS 0 Fully active, able to carry on all pre-disease performance without restriction 1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work 2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours 3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair 5. Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG
    unit Of Measure
    Participants

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