Secondary Efficacy Measures Sample Clauses

Secondary Efficacy Measures. COPD Exacerbation Rate Six exacerbation-related measures (see Section 6.3.3.2 for details), providing information on differing dimensions of this event and its impact, will be analysed in this trial. One of these, the rate of moderate and severe exacerbations, has been selected as a secondary measure, with other measures considered as supporting. This measure can be interpreted as a measure of the overall exacerbation burden experienced by patients during the period on treatment. As such, it is regarded as most clinically relevant. Other exacerbation measures are considered clinically important but provide a more limited view of the data. The rate of moderate and severe exacerbations will be analysed using a Negative Binomial model, adjusting for region of recruitment, age, sex, baseline smoking status, BMI, number of exacerbations in the 12 months prior to Screening and baseline disease severity and will also include a term for duration on treatment (to censorship or end of study as appropriate). For this analysis, data will not be imputed beyond end of study drug treatment. St. George’s Respiratory Questionnaire Only linguistically valid translations, completed in the same language throughout the study (i.e. same as that completed at Baseline (Visit 2)), will be included in the analyses of SGRQ. A transformed score will be calculated for each of the three domains (symptoms, impacts and activity) of the SGRQ and the overall total score, in accordance with the developer’s scoring guidelines. Descriptive statistics will be reported for the domains and total scores for baseline, and for all subsequent visits and at withdrawal. Change from baseline scores will be calculated by subtracting the baseline score from the score at the particular visit. Treatment comparisons for change from baseline will be analysed using repeated measures ANCOVA with smoking status, age, sex, baseline disease severity, baseline SGRQ Total score, BMI, region and visit as covariates. These comparisons will be carried out for the total score and for each of the three domains. A logistic proportional odds analysis of change in health status (improvement, no change, and deterioration based on a clinically meaningful change of 4 units), adjusting for smoking status, age, sex, baseline disease severity, baseline SGRQ Total Score, and BMI, will also be carried out as a supportive analysis. This will provide a means to assess the qualitative effect of treatment. The odds of having an improv...
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Related to Secondary Efficacy Measures

  • Safety Measures Awarded vendor shall take all reasonable precautions for the safety of employees on the worksite, and shall erect and properly maintain all necessary safeguards for protection of workers and the public. Awarded vendor shall post warning signs against all hazards created by the operation and work in progress. Proper precautions shall be taken pursuant to state law and standard practices to protect workers, general public and existing structures from injury or damage.

  • Interim Measures 6.1 The Parties acknowledge that the British Columbia Claims Task Force made the following recommendation concerning interim measures:

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  • Provisional Measures Article 50

  • Benchmarks for Measuring Accessibility For the purposes of this Agreement, the accessibility of online content and functionality will be measured according to the W3C’s Web Content Accessibility Guidelines (WCAG) 2.0 Level AA and the Web Accessibility Initiative Accessible Rich Internet Applications Suite (WAI-ARIA) 1.0 for web content, which are incorporated by reference. Adherence to these accessible technology standards is one way to ensure compliance with the College’s underlying legal obligations to ensure that people with disabilities are able to acquire the same information, engage in the same interactions, and enjoy the same benefits and services within the same timeframe as their nondisabled peers, with substantially equivalent ease of use; that they are not excluded from participation in, denied the benefits of, or otherwise subjected to discrimination in any College programs, services, and activities delivered online, as required by Section 504 and the ADA and their implementing regulations; and that they receive effective communication of the College’s programs, services, and activities delivered online.

  • Performance Measures and Metrics This section outlines the performance measures and metrics upon which service under this SLA will be assessed. Shared Service Centers and Customers will negotiate the performance metric, frequency, customer and provider service responsibilities associated with each performance measure. Measurements of the Port of Seattle activities are critical to improving services and are the basis for cost recovery for services provided. The Port of Seattle and The Northwest Seaport Alliance have identified activities critical to meeting The NWSA’s business requirements and have agreed upon how these activities will be assessed.

  • Corrective Measures If the Participating Generator fails to meet or maintain the requirements set forth in this Agreement and/or the CAISO Tariff, the CAISO shall be permitted to take any of the measures, contained or referenced in the CAISO Tariff, which the CAISO deems to be necessary to correct the situation.

  • Bilateral Safeguard Measures 1. Where, as a result of the reduction or elimination of a customs duty under this Agreement, any product originating in a Party is being imported into the territory of another Party in such increased quantities, in absolute terms or relative to domestic production, and under such conditions as to constitute a substantial cause of serious injury or threat thereof to the domestic industry of like or directly competitive products in the territory of the importing Party, the importing Party may take bilateral safeguard measures to the minimum extent necessary to remedy or prevent the injury, subject to the provisions of paragraphs 2 to 10.

  • General Measures (a) Evidence of family violence may be required and can be in the form an agreed document issued by the Police Service, a Court, a registered health practitioner, a Family Violence Support Service, district nurse, maternal and health care nurse or Lawyer. A signed statutory declaration can also be offered as evidence.

  • Safeguard Measures 1. The Parties note the multilateral negotiations pursuant to Article X of GATS on the question of emergency safeguard measures based on the principle of non- discrimination. Upon the conclusion of such multilateral negotiations, the Parties shall conduct a review for the purpose of discussing appropriate amendments to this Agreement so as to incorporate the results of such multilateral negotiations.

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