A Study in the ...
  Short Summary
    PCS increase in systolic and diastolic BP was defined as increase of ?5
millimeter mercury (mm Hg) from baseline (BL) high value to a value above
the 95th percentile at post-BL; PCS increase of pulse was defined as>140
and increase of ?15 from BL high value for age 7-11 and>120 and increase
of ?15 from BL high value for age 12-17; PCS decrease of pulse was defined
as <60 and a decrease of ?25 from BL low value for age 7-11 and <50 and
a decrease of ?15 from BL low value for age 12-17; PCS decrease of weight
was defined as decrease of at least 3.5% from BL low value.
    Least Square (LS) means are adjusted for baseline, pooled investigator,
age category, visit, treatment, treatment*visit, age category*visit and
baseline*visit.
    LS means are adjusted for baseline, pooled investigator, age category,
visit, age category*visit and baseline*visit.
    Have a significant suicide attempt within 1 year of screening or are currently
at risk of suicide in the opinion of the investigator.
  Full Summary
    CDRS-R Total score measure the presence and severity of depression in children.
    Total scores range from 17 to 113.
    In general, scores below 20 indicate an absence of depression, scores of
20 to 30 indicate borderline depression, and scores of 40 to 60 indicate
moderate depression.
    Least Square (LS) means are adjusted for baseline, pooled investigator,
age category, visit, treatment, treatment*visit, age category*visit and
baseline*visit.
    LS means are adjusted for baseline, pooled investigator, age category,
visit, age category*visit and baseline*visit.
    Mood and Subjective subscale scores range from 4 to 28; Somatic subscale
scores range from 6 to 36; Behavior subscale scores range from 3 to 21.
    Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and
frequency of suicide-related thoughts and behaviors.
    Potentially clinically significant hepatic laboratory results at any time
are defined as alanine transaminase (ALT) ?3 x upper limit of normal (ULN),
ALT ?5 x ULN and ALT ?10 x ULN, as well as ALT ?3 x ULN and Total Bilirubin
?2 x ULN.
    PCS increase in systolic and diastolic BP was defined as increase of ?5
millimeter mercury (mm Hg) from baseline (BL) high value to a value above
the 95th percentile at post-BL; PCS increase of pulse was defined as>140
and increase of ?15 from BL high value for age 7-11 and>120 and increase
of ?15 from BL high value for age 12-17; PCS decrease of pulse was defined
as <60 and a decrease of ?25 from BL low value for age 7-11 and <50 and
a decrease of ?15 from BL low value for age 12-17; PCS decrease of weight
was defined as decrease of at least 3.5% from BL low value.
    Diagnosis of moderate or greater severity of MDD as determined by Children's
Depression Rating Scale - Revised (CDRS-R) with a total score greater than
or equal to 40 at screen, and randomization and a Clinical Global Impression
of Severity (CGI-Severity) rating of greater than or equal to 4 at screen,
and randomization.
    Have a significant suicide attempt within 1 year of screening or are currently
at risk of suicide in the opinion of the investigator.
    Have had treatment with a monoamine oxidase inhibitor (MAOI) within 14
days or fluoxetine within 30 days of randomization; or the potential need
to use an MAOI during the study or within 5 weeks of discontinuation of
study drug.
  age (100)
    Least Square (LS) means are adjusted for baseline, pooled investigator,
age category, visit, treatment, treatment*visit, age category*visit and
baseline*visit.
    LS means are adjusted for baseline, pooled investigator, age category,
visit, age category*visit and baseline*visit.
    PCS increase in systolic and diastolic BP was defined as increase of ?5
millimeter mercury (mm Hg) from baseline (BL) high value to a value above
the 95th percentile at post-BL; PCS increase of pulse was defined as>140
and increase of ?15 from BL high value for age 7-11 and>120 and increase
of ?15 from BL high value for age 12-17; PCS decrease of pulse was defined
as <60 and a decrease of ?25 from BL low value for age 7-11 and <50 and
a decrease of ?15 from BL low value for age 12-17; PCS decrease of weight
was defined as decrease of at least 3.5% from BL low value.
  suicide (85)
    Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and
frequency of suicide-related thoughts and behaviors.
    Have a significant suicide attempt within 1 year of screening or are currently
at risk of suicide in the opinion of the investigator.
  investigator (60)
    Least Square (LS) means are adjusted for baseline, pooled investigator,
age category, visit, treatment, treatment*visit, age category*visit and
baseline*visit.
    LS means are adjusted for baseline, pooled investigator, age category,
visit, age category*visit and baseline*visit.
    Have a significant suicide attempt within 1 year of screening or are currently
at risk of suicide in the opinion of the investigator.
  depression (55)
    CDRS-R Total score measure the presence and severity of depression in children.
    In general, scores below 20 indicate an absence of depression, scores of
20 to 30 indicate borderline depression, and scores of 40 to 60 indicate
moderate depression.
    Diagnosis of moderate or greater severity of MDD as determined by Children's
Depression Rating Scale - Revised (CDRS-R) with a total score greater than
or equal to 40 at screen, and randomization and a Clinical Global Impression
of Severity (CGI-Severity) rating of greater than or equal to 4 at screen,
and randomization.
  treatment (50)
    Least Square (LS) means are adjusted for baseline, pooled investigator,
age category, visit, treatment, treatment*visit, age category*visit and
baseline*visit.
    Have had treatment with a monoamine oxidase inhibitor (MAOI) within 14
days or fluoxetine within 30 days of randomization; or the potential need
to use an MAOI during the study or within 5 weeks of discontinuation of
study drug.
  baseline (50)
    Least Square (LS) means are adjusted for baseline, pooled investigator,
age category, visit, treatment, treatment*visit, age category*visit and
baseline*visit.
    LS means are adjusted for baseline, pooled investigator, age category,
visit, age category*visit and baseline*visit.
    PCS increase in systolic and diastolic BP was defined as increase of ?5
millimeter mercury (mm Hg) from baseline (BL) high value to a value above
the 95th percentile at post-BL; PCS increase of pulse was defined as>140
and increase of ?15 from BL high value for age 7-11 and>120 and increase
of ?15 from BL high value for age 12-17; PCS decrease of pulse was defined
as <60 and a decrease of ?25 from BL low value for age 7-11 and <50 and
a decrease of ?15 from BL low value for age 12-17; PCS decrease of weight
was defined as decrease of at least 3.5% from BL low value.
  scores range (50)
    Total scores range from 17 to 113.
    Mood and Subjective subscale scores range from 4 to 28; Somatic subscale
scores range from 6 to 36; Behavior subscale scores range from 3 to 21.
  severity (50)
    CDRS-R Total score measure the presence and severity of depression in children.
    Columbia Suicide Rating Scale (C-SSRS) captures occurrence, severity, and
frequency of suicide-related thoughts and behaviors.
    Diagnosis of moderate or greater severity of MDD as determined by Children's
Depression Rating Scale - Revised (CDRS-R) with a total score greater than
or equal to 40 at screen, and randomization and a Clinical Global Impression
of Severity (CGI-Severity) rating of greater than or equal to 4 at screen,
and randomization.
  decrease (42)
    PCS increase in systolic and diastolic BP was defined as increase of ?5
millimeter mercury (mm Hg) from baseline (BL) high value to a value above
the 95th percentile at post-BL; PCS increase of pulse was defined as>140
and increase of ?15 from BL high value for age 7-11 and>120 and increase
of ?15 from BL high value for age 12-17; PCS decrease of pulse was defined
as <60 and a decrease of ?25 from BL low value for age 7-11 and <50 and
a decrease of ?15 from BL low value for age 12-17; PCS decrease of weight
was defined as decrease of at least 3.5% from BL low value.
  ULN (42)
    Potentially clinically significant hepatic laboratory results at any time
are defined as alanine transaminase (ALT) ?3 x upper limit of normal (ULN),
ALT ?5 x ULN and ALT ?10 x ULN, as well as ALT ?3 x ULN and Total Bilirubin
?2 x ULN.
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