Secondary Outcome(s)
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Expanded Disability Status Scale (EDSS)
[Time Frame: Up to approximately 3 years]
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Fatigue Severity Scale (FSS)
[Time Frame: Up to approximately 3 years]
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GdE lesion volume over 3 years
[Time Frame: Up to approximately 3 years]
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Number of unique new or enlarging hypointense T1 weighted lesions and their volume from baseline to Year 3
[Time Frame: Up to approximately 3 years]
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Work Productivity and Activity Impairment-Multiple Sclerosis (WPAI-MS)
[Time Frame: Up to approximately 3 years]
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Annualized relapse rate (ARR)
[Time Frame: Up to approximately 3 years]
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Treatment Satisfaction Questionnaire for Medication (TSQM v1.4)
[Time Frame: Up to approximately 3 years]
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Number of unique new or enlarging hyperintense T2-weighted lesions and their volume from baseline to Year 3
[Time Frame: Up to approximately 3 years]
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Proportion of subjects with an increase in raw score of = 3 points from baseline
[Time Frame: Up to approximately 3 years]
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Adverse Events (AEs)
[Time Frame: Up to approximately 3 years]
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Nine-hole Peg Test (9-HPT)
[Time Frame: Up to approximately 3 years]
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Hospital Anxiety and Depression Scale (HADS)
[Time Frame: Up to approximately 3 years]
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Percent change from baseline in thalamic, cortical grey matter, whole brain, lateral ventricular, and MOV volumes
[Time Frame: Up to approximately 3 years]
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Proportion of subjects free of gadolinium enhancing (GdE) lesions over 3 years
[Time Frame: Up to approximately 3 years]
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Proportion of subjects with a raw score change from baseline who do not meet the improved or worsened definition (stable)
[Time Frame: Up to approximately 3 years]
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Change from baseline in Symbol Digit Modalities Test (SMDT)
[Time Frame: Up to approximately 3 years]
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Multiple Sclerosis Quality of Life-54 (MSQOL-54)
[Time Frame: Up to approximately 3 years]
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Proportion of subjects with a decrease in raw score of = 3 points from baseline
[Time Frame: Up to approximately 3 years]
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Proportion of subjects with a decrease in raw score of = 4 points or 10% from baseline (worsened)
[Time Frame: Up to approximately 3 years]
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Timed 25-foot Walk (T25W)
[Time Frame: Up to approximately 3 years]
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