2.3. Statistical analyses
Analyses presented here include the following: descriptive statistics
for adult patient demographics and baseline characteristics; the number
and type of prior and concomitant AEDs; comorbid conditions (given
as vision testing exemptions); the number and percentage of patients
who received maintenance vigabatrin treatment; median duration of
vigabatrin treatment; and retention rates estimated by landmark and
Kaplan–Meier analyses. The SHARE program was performed as part of
a FDA required REMS program thus there was no IRB approval.