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NCT02685826 · BASELINE

Baseline characteristics

A Study of Durvalumab in Combination With Lenalidomide With and Without Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma · Source last updated 2023-10-06

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
      25
    2. group Id
      BG001
      value
      10
    3. group Id
      BG002
      value
      21
    4. group Id
      BG003
      value
      56
    units
    Participants
groups
  1. description
    High risk, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.
    id
    BG000
    title
    Cohort A: High Risk, TNE
  2. description
    \>= 65 years old, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles.
    id
    BG001
    title
    Cohort B: >=65 Years Old, TNE
  3. description
    High risk, post-transplant NDMM participants were administered the following as maintenance therapy: • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle.
    id
    BG002
    title
    Cohort C: High Risk, Post-transplant
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.17
          value
          75.4
        2. group Id
          BG001
          spread
          5.25
          value
          72.5
        3. group Id
          BG002
          spread
          7.52
          value
          59.6
        4. group Id
          BG003
          spread
          9.33
          value
          68.98
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          17
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
      title
      <=65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          39
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
      title
      >65 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          39
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
      title
      <=75 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          17
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
      title
      >75 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          19
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          37
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    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
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          47
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          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
          4
        4. group Id
          BG003
          value
          6
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          25
        title
        0 = Fully Active
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          27
        title
        1 = Restrictive but ambulatory
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        title
        2 = ambulatory but unable to work
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
    description
    ECOG performance status is used to assess how a subject's disease is progressing, and how the disease affects the daily living activities and determine appropriate treatment and prognosis. 0 = Fully Active, able to carry on all pre-disease performance without restriction; 1 = Restricted, in physically strenuous activity but ambulatory; 2 = Ambulatory and capable of all self-care; unable to carry out work activities; 3 = Capable of only limited self-care, confined to bed or chair \>50% of waking hours; 4 = Completely Disabled, cannot carry on any self-care.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          10
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          19
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          24
        title
        Stage III
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
    description
    Multiple myeloma has three stages, which are known as stage I, stage II and stage III. Staging in myeloma is done on the basis of the value of serum albumin and beta-2 microglobulin level. Stage I has the best prognosis and stage III the worst prognosis.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Staging System (ISS) for MM at Diagnosis
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          19
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          37
        title
        No
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    High-Risk Cytogenetic Abnormalities at Baseline
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG002
          value
          21
        2. group Id
          BG003
          value
          21
        title
        Positive
      2. measurements
        1. group Id
          BG002
          value
          0
        2. group Id
          BG003
          value
          0
        title
        Negative
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          21
        units
        Participants
    description
    MRD status is either positive or negative. Positive was defined as more than 1 malignant cells in 10\^5 cells as measured by the ClonoSIGHT(TM) NGS (next generation sequencing) assay of a bone marrow aspirate sample.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Data was collected for Cohort C only.
    title
    Minimal Residual Disease (MRD) Status
    unit Of Measure
    Participants
population Description
Full analysis population. The Full Analysis Population (FAS) is defined as all participants who are enrolled (signed the inform consent form and meet all eligibility criteria) in the study. Participants are analyzed according to the initial cohort actually assigned.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      25
    2. group Id
      BG001
      value
      10
    3. group Id
      BG002
      value
      21
    4. group Id
      BG003
      value
      56
    units
    Participants
groups
  1. description
    High risk, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle.
    id
    BG000
    title
    Cohort A: High Risk, TNE
  2. description
    \>= 65 years old, transplant non-eligible \[TNE\], newly diagnosed multiple myeloma (NDMM) participants who were not high risk were administered • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 25 mg/day (adjust per the creatinine clearance \[CrCl\] value) on Days 1 to 21 of each 28-day treatment cycle • Oral dexamethasone (dex) 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15, and 22 of each 28-day cycle, up to 12 cycles.
    id
    BG001
    title
    Cohort B: >=65 Years Old, TNE
  3. description
    High risk, post-transplant NDMM participants were administered the following as maintenance therapy: • Intravenous (IV) durvalumab at 1500 mg on Day 1 of each 28-day cycle • Oral lenalidomide (LEN) 10 mg/day on Days 1 to 21 of each 28-day treatment cycle.
    id
    BG002
    title
    Cohort C: High Risk, Post-transplant
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          4.17
          value
          75.4
        2. group Id
          BG001
          spread
          5.25
          value
          72.5
        3. group Id
          BG002
          spread
          7.52
          value
          59.6
        4. group Id
          BG003
          spread
          9.33
          value
          68.98
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          17
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
      title
      <=65 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          39
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
      title
      >65 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          20
        4. group Id
          BG003
          value
          39
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
      title
      <=75 years
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          3
        3. group Id
          BG002
          value
          1
        4. group Id
          BG003
          value
          17
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
      title
      >75 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          4
        4. group Id
          BG003
          value
          19
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          10
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          37
        title
        Male
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    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
        4. group Id
          BG003
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          2
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          0
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          9
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          47
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          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
          4
        4. group Id
          BG003
          value
          6
        title
        Unknown or Not Reported
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          25
        title
        0 = Fully Active
      2. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          8
        4. group Id
          BG003
          value
          27
        title
        1 = Restrictive but ambulatory
      3. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          4
        title
        2 = ambulatory but unable to work
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
    description
    ECOG performance status is used to assess how a subject's disease is progressing, and how the disease affects the daily living activities and determine appropriate treatment and prognosis. 0 = Fully Active, able to carry on all pre-disease performance without restriction; 1 = Restricted, in physically strenuous activity but ambulatory; 2 = Ambulatory and capable of all self-care; unable to carry out work activities; 3 = Capable of only limited self-care, confined to bed or chair \>50% of waking hours; 4 = Completely Disabled, cannot carry on any self-care.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Eastern Cooperative Oncology Group (ECOG) Performance Status
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          3
        4. group Id
          BG003
          value
          10
        title
        Stage I
      2. measurements
        1. group Id
          BG000
          value
          7
        2. group Id
          BG001
          value
          5
        3. group Id
          BG002
          value
          7
        4. group Id
          BG003
          value
          19
        title
        Stage II
      3. measurements
        1. group Id
          BG000
          value
          13
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          11
        4. group Id
          BG003
          value
          24
        title
        Stage III
      4. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
        title
        Missing
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
    description
    Multiple myeloma has three stages, which are known as stage I, stage II and stage III. Staging in myeloma is done on the basis of the value of serum albumin and beta-2 microglobulin level. Stage I has the best prognosis and stage III the worst prognosis.
    param Type
    COUNT_OF_PARTICIPANTS
    title
    International Staging System (ISS) for MM at Diagnosis
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          2
        4. group Id
          BG003
          value
          19
        title
        Yes
      2. measurements
        1. group Id
          BG000
          value
          8
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          37
        title
        No
      denoms
      1. counts
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          10
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          56
        units
        Participants
    param Type
    COUNT_OF_PARTICIPANTS
    title
    High-Risk Cytogenetic Abnormalities at Baseline
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG002
          value
          21
        2. group Id
          BG003
          value
          21
        title
        Positive
      2. measurements
        1. group Id
          BG002
          value
          0
        2. group Id
          BG003
          value
          0
        title
        Negative
      denoms
      1. counts
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          21
        4. group Id
          BG003
          value
          21
        units
        Participants
    description
    MRD status is either positive or negative. Positive was defined as more than 1 malignant cells in 10\^5 cells as measured by the ClonoSIGHT(TM) NGS (next generation sequencing) assay of a bone marrow aspirate sample.
    param Type
    COUNT_OF_PARTICIPANTS
    population Description
    Data was collected for Cohort C only.
    title
    Minimal Residual Disease (MRD) Status
    unit Of Measure
    Participants
population Description
Full analysis population. The Full Analysis Population (FAS) is defined as all participants who are enrolled (signed the inform consent form and meet all eligibility criteria) in the study. Participants are analyzed according to the initial cohort actually assigned.

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