A need for injection of BTX defined as a Jankovic Rating Scale severity subscore ≥ 2.A clinical diagnosis of bilateral BEB characterized by spontaneous, spasmodic, intermittent or persistent involuntary contractions of orbicular oculi muscles.Male or female out-patients age ≥ 18 and ≤ 80 years.Double-blind MP: Patient Evaluation of Global Response (PEGR) at Final Visit (Day 43-Day 141).Negative values denote an improvement, while positive values denote deterioration vs. Missings were replaced by the LOCF method. Outcome values represent LS mean differences between baseline and visit 4 (visit 4 value minus baseline value) resulting from ANCOVA with treatment group, pooled site, gender as fixed factors and baseline BSDI total score, age as covariates. It is calculated by adding scores of all applicable and answered items, and dividing the resulting sum by the number of items answered. The BSDI total score is a mean score for non-missing items ranging from 0 to 4.
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BSDI consists of six items (driving a vehicle reading watching TV shopping getting about on foot (walking) doing everyday activities), each ranging from 0 (=no impairment) to 4 (=no longer possible due to illness).