SPDS 09052014 - page 219

Cognition study results
Effect Size - Sensoril 500 mg/day
Cohen’s “d” Effect Size
a b
a b
0.2 Small
0.5 Medium
0.8 Large
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Working memory – Digit Span Backwards: (a) number correct backward; (b) span backward
Social Cognition - Penn Emotional Acuity Test: mean response rating; Attention - Flankers
Continuous Performance Test: (a) RT neutral mean; (b) RT neutral median
CONFIDENTIAL
Cognition study results –Adverse Events
Sensoril Study- Adverse Events by Event (n=60) 19 Events in Sensoril (n=30) 26 Events in Placebo (n=30)
Nervous System
 Sleepiness 3 6
 headache 0 2
i id d / i ht 3 3  v v reams n g mares
 dizziness 1 0
 tiredness/fatigue 1 2
 lightheadedness 0 1
Gastrointestinal
 nausea/upset stomach 1 4
 constipation 0 2
 diarrhea 5 1
 decrease in appetite 0 1
 increase in gas 1 0
Dermatological
 rash 1 1
 itching 0 1
Cardiovascular
 palpitations 0 1
Circulatory
 swelling in feet 1 0
 heaviness in legs 0 1
 tingling in fingers 0 1
Psychiatric
 increase in depression 1 1
Genitourinary
 frequent urination 1 0
Respiratory
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CONFIDENTIAL