8.4. Exploratory Endpoint (Alive Without Event [ AWE] at the Six -Month LTFU Visit ) T he AWE at the 6 month LTFU visit endpoint will be analyzed using stratified logistic regression. The estimated odds ratio will be greater than unity if the experimental arm has a more favorable outcome. T he 95% confidence interval on the odds ratio estimate will be computed as the measure of the magnitude of effect. A ll analyses of AWE at the 6 month LTFU visit will be conducted on the ITT set, excluding subjects not alive at the Week 25 (EOT) visit. 8.5.