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The primary efficacy assessment was the mean change from baseline assessed at week 8 in total IDS-C30 score for adjunctive armodafinil 150 mg/day versus adjunctive placebo as analyzed by mixed-model repeated measures (MMRM).
The primary efficacy assessment was the sum of pain intensity differences at 30 min (SPID30) postdose.
The 18-week follow-up period was the primary efficacy assessment period.
The primary efficacy assessment is the change in HbA1c levels from baseline.
The primary efficacy assessment in the randomised, controlled portion of ATLAS was the ASAS20.
The primary efficacy assessment was the change in ADHD-RS-IV total score from baseline to endpoint.
Similar(38)
Primary efficacy assessments for NYHA functional class and self-reported patient global assessment (PGA) are performed at weeks 4, 12 and 24.
Primary efficacy measures included direct assessment of arthritis by counts of tender and swollen joints, and patient and investigator global assessments of disease activity.
The primary endpoint for the efficacy assessment was a satisfactory improvement in subjective symptoms at Week 8, defined as physician-reported symptoms during the preceding week being "None" or "Only mild symptoms for 1 day".
The primary efficacy end points were global assessment of overall treatment efficacy (OTE) and elimination rate of all three meal-related symptoms (postprandial fullness, upper abdominal bloating and early satiation), as derived from daily diaries.
Efficacy analyses were based on a modified intent-to-treat set the full-analysis set (FAS), comprising all patients in the APTS who had a valid baseline assessment and at least one valid postbaseline assessment of the primary efficacy variable (MADRS total score).
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