Statistical Hypotheses. No inferences are to be made on the primary effectiveness endpoint; therefore, no hypotheses are formulated.
Statistical Hypotheses. The null and alternative hypotheses are formulated in terms of the predefined margin of 0.05 for noninferiority: H0: µ(T) – µ(C) ≥ 0.05 Ha: µ(T) – µ(C) < 0.05 where µ(T) and µ(C) denote the mean distance VA for DT1 and Infuse, respectively, on the logMAR scale.
Statistical Hypotheses. The null and alternative hypotheses are formulated in terms of the predefined margin of 0.10 (in logMAR scale) for noninferiority: H0: μ(T) − μ(C) ≥ 0.10 Ha: μ(T) − μ(C) < 0.10 where μ(T) and μ(C) denote the Week 1 Follow-up mean CLCDVA for contact lenses, respectively, on the logMAR scale. and Biofinity
Statistical Hypotheses. The null and alternative hypotheses are formulated in terms of the predefined margin of 0.10 (10%) for noninferiority. H0: P(T) – P(C) ≤ -0.10 Ha: P(T) – P(C) > -0.10 where P(T) and P(C) denote the proportion of subjects attaining at least 20/20 in CLCDVA at Week 1 Follow-up in each eye (OD and OS) for and Biofinity contact lenses, respectively.
Statistical Hypotheses. No hypothesis testing of the primary effectiveness endpoint is planned.
Statistical Hypotheses. The null and alternative hypotheses are formulated in terms of the predefined margin of 1.0 for noninferiority: H0: μ(DACP D) - μ(DACP) ≤ -1.0 Ha: μ(DACP D) - μ(DACP) > -1.0 where μ(DACP D) and μ(DACP) denote the mean overall vision rating for DACP Digital and DACP, respectively.
Statistical Hypotheses. The null and alternative hypotheses are formulated in terms of the predefined margin of 0.05 for noninferiority: H0: μ(T) - μ(C) ≥ 0.05 Ha: μ(T) - μ(C) < 0.05 where μ(T) and μ(C) denote the mean distance logMAR VA for DACP FreshTech and DACP, respectively, at Week 1 Follow-up. • Device deficiencies There are no safety hypotheses planned in this study. The focus of the safety analysis will be a comprehensive descriptive assessment of occurrence of adverse events as well as the other listed parameters. All AEs occurring from the time a subject signs informed consent to study exit will be accounted for in the reporting. Safety analyses will be conducted using the safety analysis set on a treatment-emergent basis. Descriptive summaries (counts and percentages) for ocular and nonocular AEs will be presented by Medical Dictionary for Regulatory Activities Preferred Terms. AEs leading to study discontinuation, significant non-serious AEs, and SAEs will be identified. Individual subject listings will be provided, as necessary. Individual subject listings will be provided for AEs that occur after signing informed consent but prior to exposure to IP. Each biomicroscopy parameter will be tabulated by its grade. For each biomicroscopy parameter, counts and percentages of eyes that experience an increase of ≥ 2 grades from baseline (last assessment prior to study lens exposure) to any subsequent visit within the same period will be presented. A supportive listing will be generated which will include all biomicroscopy data from all visits within the same period for those eyes experiencing the increase. Two listings for device deficiencies, prior to exposure of study lenses and treatment- emergent, will be provided. Additionally, each device deficiency category will be tabulated. No inferential testing will be done for safety analysis.
Statistical Hypotheses. The primary objective will be to estimate the treatment effect of vibegron relative to placebo with respect to improvement in IBS-related abdominal pain in IBS-D subjects. There is no formal statistical hypothesis. Nominal p-values from comparisons to placebo may be provided for descriptive purposes. An improvement in the primary endpoint is defined as a subject who experiences a decrease in the weekly average of “worst abdominal pain in the past 24 hours” scores of at least 30% compared with the baseline weekly average.
Statistical Hypotheses. The null and alternative hypotheses for the primary analysis are: H0: µTFNT00VA - µ839MPVA ≥ ∆
Statistical Hypotheses. The null and alternative hypotheses for the first, fourth and fifth secondary analysis are: H0: µTFNT00VA ≥ µ839MPVA HA: µ TFNT00VA < µ839MPVA where µ TFNT00VA, µ839MPVA, refer to the mean binocular high contrast UCIVA, UCNVA or UCDVA for the test and control lenses, respectively. The null and alternative hypotheses for the second and third secondary analysis are: H0: µ TFNT00VA - µ839MPVA ≥ ∆ HA: µ TFNT00VA - µ839MPVA < ∆ where, ∆ refers to the non-inferiority margin, set at 0.1 logMAR, and µTFNT00VA, µ839MPVA, refer to the mean binocular high contrast UCDVA or UCNVA for the test and control lenses, respectively.
