, respectively. Placebo or drug was administered for up to 18 months of treatment. Subjects were treated at baseline through to visit 17. Efficacy endpoints were assessed on visit 17 after 18 months of study drug exposure, and a month 18 visit or phone call at the end of the safety analysis period, which spans a total of 18 months. Subjects were then followed for an additional ~3 months for safety and laboratory assessments.
The ITT population consisted of all randomized subjects categorized by their randomized treatment assignment. The mITT population consisted of all randomized subjects who had received at least one complete infusion of study drug and had at least one post-infusion efficacy evaluation for one of the coprimary efficacy outcomes—that is, cognition or CGIC.
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