Item
1. Did the subject meet all the Cognitive Function substudy entry criteria?
text
Code List
1. Did the subject meet all the Cognitive Function substudy entry criteria?
CL Item
No, please select all boxes corresponding to violations of any inclusion/exclusion criteria (N)
Informed consent
Item
[I08] Cognitive Function 1. Signed written informed consent prior to beginning substudy-related procedures (subject must understand the aims, investigational procedures and possible consequences of the substudy).
boolean
Vision and hearing
Item
[I09] Cognitive Function 2. Adequate vision and hearing for neuropsychological testing.
boolean
High level cognitive function
Item
[E22] Cognitive Function 1. High level of cognitive function as assessed by a score of >50 on the Symbol Digit Modalities Test.
boolean
deficit in verbal intelligence
Item
[E23] Cognitive Function 2. Significant deficit in verbal intelligence as assessed by Adult Reading Test score <85.
boolean
Aphasia
Item
[E24] Cognitive Function 3. Aphasia
boolean
weakness in dominant hand
Item
[E25] Cognitive Function 4. Inability to perform the test due to significant weakness in dominant hand.
boolean
Item
1. Cognitive function testing completed
text
Code List
1. Cognitive function testing completed
Date cognitive function testing
Item
1. Date cognitive function testing completed
date
Item
1. Cognitive function testing
text
Code List
1. Cognitive function testing
CL Item
Previously assessed at Month 24 visit (1)
CL Item
Testing at Early Withdrawal IP or Follow-up visit (2)
Date cognitive function testing Early Withdrawal Follow-up
Item
Date of cognitive function testing (at Early Withdrawal IP or Follow-up visit)
date