Change from baseline to Day 22 in sum of all speed domain Z-scores:Reaction Time (Simple=recognize "yes" 50 times;Choice=recognize "yes" or "no" 50 times;Digit Vigilance=match 45 digits);Psychomotor Speed (Morse Tapping=tap button for 30 seconds with right & left hands);Processing Speed (Rapid Visual Information Processing=detect consecutive sequences of 3 odd or 3 even digits;Numeric Working Memory=recognize numbers from series of 5 digits among 30;Word Recognition=remember 15 prior learned words from 30 total;results age-matched to healthy controls from Cognitive Drug Research normative data

Analysis based upon observed cases (OC).

Change from baseline in the individual neurocognitive domains Z-score for Reaction Time in Computer Tests (simple reaction time test, choice reaction time test, digit vigilance test); ITT population

ITT population with OC

Change from baseline to Day 22 in the individual neurocognitive domains Z-score for Psychomotor Speed (mean tap rate of Morse tapping test); ITT population

ITT population with OC

Change from baseline to Day 22 in the individual neurocognitive domains Z-score for Processing Speed of Rapid Visual Information Processing Test, Numeric Working Memory Test, and Word Recognition Test; ITT population

ITT population with OC

Change from Baseline to Day 22 in the overall Neurocognitive Composite Score (NCS)comprising the sum of 7 neurocognitive domain Z-scores (Reaction Time, Psychomotor Speed, Processing Speed, Continuity of Attention, Working Memory/Executive Functions, Quality of Episodic Verbal Memory, and Postural Stability); ITT population

ITT population with OC

Change from baseline to Day 22 in Gait Test (Timed Get-Up-and-Go Test=time it takes for a seated subject to rise from a chair, walk 3 meters, walk around an object and return to sit in chair. Values: under 10 sec (no difficulties), 10 to 20 sec (starting to have balance difficulty), over 30 sec (at high risk for falls and dependent in most activities of daily living and mobility); test assesses risk to elderly subjects of falling and higher scores in seconds indicate higher risk of falling; ITT population

ITT population with OC

Change from baseline to Day 22 in Postural Stability Test Z-score (This test measures gross motor control. The ability to stand upright without moving is assessed using the SWAY meter that is modeled on the Wright Ataxiameter. A cord from the meter is attached to the subject who is required to stand as still as possible with feet apart and eyes closed for 1 minute. The test is then repeated with eyes open for 1 minute. The outcomes of these tests are combined and measured as a movement Z-score. Higher result=better postural stability); ITT population

ITT population with LOCF (this group includes missing values)

Change from Baseline to Day 22 in Serum Sodium; ITT population

ITT population with OC

Incidence of abnormal systolic & diastolic blood pressure values post-baseline (abnormal systolic values: >=180 mmHg + increase of >=20 mmHg, <= 90 mmHg + decrease >=20 mmHg; abnormal diastolic values: >=105 mmHg+increase of >=15 mmHg, <=50 mmHg + decrease of >= 15 mmHg)

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of abnormal pulse rate post-baseline [abnormal values: >=120 beats per minute (bpm) + increase of >=15 bpm; <=50 bpm + decrease of >=15 bpm]

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of clinically significant body weight change post-baseline (defined as change upward or downward of >=7%)

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of potentially clinically significant changes in body temperature post-baseline (defined as an increase of >=1.1 to >=38.3 degrees Celsius)

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of clinically significant hemoglobin abnormalities post-baseline (normal range=11.8-16.8 g/dL)

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of potentially clinically significant Activated Partial Thromboplastin Time (aPTT) levels post-baseline (normal range=22-34 seconds)

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of potentially clinically significant lymphocyte count post-baseline (normal range = 16-46%)

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of potentially clinically significant neutrophil count post-baseline (normal range=1.8-8 thousands/microliter)

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of potentially clinically significant BUN levels post-baseline (normal range=7-30 mg/dL)

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of potentially clinically significant uric acid levels post-baseline (normal range=4-8.5 mg/dL)

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of potentially clinically significant cholesterol levels post-baseline (normal range=0-199 mg/dL)

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of potentially clinically significant glucose levels post-baseline (normal range=70-125 mg/dL)

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of potentially clinically significant magnesium levels post-baseline (normal range=1.2-2 mEq/L)

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of potentially clinically significant ECG abnormalities (QT>500 msec) post-baseline

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of potentially clinically significant ECG abnormalities involving QRS interval (change > 100 msec)

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of potentially clinically significant ECG abnormalities (QTcB increase 30-60 msec)

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of potentially clinically significant ECG abnormalities (QTcF increase 30-60 msec post-baseline)

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of potentially clinically significant ECG abnormalities: ST Segment

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of potentially clinically significant ECG abnormalities: T wave

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of potentially clinically significant ECG abnormalities: Right bundle branch block (RBBB), Left bundle branch block (LBBB), myocardial infarction (MI)

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication

Incidence of potentially clinically significant ECG abnormalities: arrhythmia

Safety population defined as all randomized subjects who consumed at least 1 dose of trial medication