Statistical analysis
SSHL
ADVERSE EVENTS
The statistical analysis plan is available in Supplemental Material 1.Based on 2-sided The primary analysis is based on the intention-to-treat population (full analysis set; FAS); in addition, a per-protocol analysis (excluding patients not fulfilling the evaluability criteria; per-protocol set, PPS) was performed. Evaluability criteria were: SSHL as defined per inclusion criterion; valid PTA data for day 1 and 8; adhere reasonably well to the study protocol without major protocol deviations.Quantitative efficacy variables (including the primary efficacy variable) were analyzed by means of an analysis of covariance (ANCOVA) based on the generalized linear model with treatment group (fixed factor) and the covariates baseline value and country (study centers were pooled according to an external factor: country). For the primary efficacy variable, confirmative testing was performed aiming to show superiority in favor of ancrod over placebo. Qualitative parameters were analyzed with Fisher's exact test (2 × 2-tables) or the Freeman-Halton test (tables larger than 2 × 2). A two-sided 5% significance level was applied. All other variables were compared between treatment groups in an explorative manner.Subgroups were evaluated descriptively for the primary efficacy endpoint. Subgroup analyses and a step-down ANCOVA were applied to identify risk or influential factors.Safety data were analyzed descriptively by treatment group. Absolute and relative frequencies were calculated for adverse events (AEs) by system organ class and preferred term. AE rates were compared between the treatment groups by Fisher’s exact test.Statistical analyses were performed using the SAS