Hierarchical Analysis of Secondary Endpoints Sample Clauses

Hierarchical Analysis of Secondary Endpoints. A hierarchical analysis will be performed in the order listed for the following secondary efficacy endpoints at Week 6 after the first IMP administration: (1) Proportion of subjects with no episodes of UI (i.e. continence is achieved):  measured by 7-day bladder diary. (2) Mean change from study Baseline (assessed at Screening) in the I-QoL total summary score:  measured by patient-reported questionnaire. See Section 9.3 for further details regarding control of type one error for these secondary efficacy endpoints. See Table 19 in Section 7.2 for the full list of secondary efficacy endpoints for both the initial treatment and for retreatments.
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Hierarchical Analysis of Secondary Endpoints. A hierarchical analysis will be performed in the order listed for the following secondary efficacy endpoints at Week 6 after the first IMP administration: 1) Mean change from study Baseline (assessed at Screening) in the MCC:  measured by urodynamic filling cystometry. 2) Mean change from study Baseline (assessed at Screening) in the MDP during storage:  measured by urodynamic filling cystometry. 3) Mean change from study Baseline (assessed at Screening) in the Vol@1stIDC:  measured by urodynamic filling cystometry. 4) Proportion of subjects with no episodes of UI (i.e. continence is achieved):  measured by 7-day bladder diary. 5) Proportion of subjects with no IDCs during storage:  measured by urodynamic filling cystometry. 6) Mean change from study Baseline (assessed at Screening) in the I-QoL total summary score:  measured by patient-reported questionnaire.

Related to Hierarchical Analysis of Secondary Endpoints

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  • Evaluation, Testing, and Monitoring 1. The System Agency may review, test, evaluate and monitor Grantee’s Products and services, as well as associated documentation and technical support for compliance with the Accessibility Standards. Review, testing, evaluation and monitoring may be conducted before and after the award of a contract. Testing and monitoring may include user acceptance testing. Neither the review, testing (including acceptance testing), evaluation or monitoring of any Product or service, nor the absence of review, testing, evaluation or monitoring, will result in a waiver of the State’s right to contest the Grantee’s assertion of compliance with the Accessibility Standards. 2. Grantee agrees to cooperate fully and provide the System Agency and its representatives timely access to Products, records, and other items and information needed to conduct such review, evaluation, testing, and monitoring.

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