Primary Analysis of Efficacy Sample Clauses

Primary Analysis of Efficacy. ‌ The intent-to-treat (ITT) population, which includes all randomized patients who received at least one dose of study medication, will be used as the primary population for assessment of efficacy. Likelihood-based estimation with mixed-model repeated measures (MMRM) analysis will compare the treatment groups with respect to the primary endpoint. The dependent variable will be change from baseline in 6MWD. The model will include treatment, visit, and the treatment-by-visit interactions as fixed effects; stratification by number of background PAH therapies (0, 1, or 2); and visit as a repeated measure having an unstructured covariance structure. Covariates may be defined in the SAP as appropriate. Missing data will not be imputed for the primary analysis. To assess the assumption of missing at random (MAR), a tipping point approach for imputing missing data will be performed as a sensitivity analysis. Shift parameters will adjust the imputed values for observations in the treatment group, not the placebo group, until the p-value > 0.05. Multiple imputation will be used for missing data. Other sensitivity analyses may be performed as appropriate.
Sample 1
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Related to Primary Analysis of Efficacy

  • Data Analysis In the meeting, the analysis that has led the College President to conclude that a reduction- in-force in the FSA at that College may be necessary will be shared. The analysis will include but is not limited to the following: ● Relationship of the FSA to the mission, vision, values, and strategic plan of the College and district ● External requirement for the services provided by the FSA such as accreditation or intergovernmental agreements ● Annual instructional load (as applicable) ● Percentage of annual instructional load taught by Residential Faculty (as applicable) ● Fall Full-Time Student Equivalent (FFTE) inclusive of dual enrollment ● Number of Residential Faculty teaching/working in the FSA ● Number of Residential Faculty whose primary FSA is the FSA being analyzed ● Revenue trends over five years for the FSA including but not limited to tuition and fees ● Expenditure trends over five years for the FSA including but not limited to personnel and capital ● Account balances for any fees accounts within the FSA ● Cost/benefit analysis of reducing all non-Residential Faculty plus one Residential Faculty within the FSA ● An explanation of the problem that reducing the number of faculty in the FSA would solve ● The list of potential Residential Faculty that are at risk of layoff as determined by the Vice Chancellor of Human Resources ● Other relevant information, as requested

  • Statistical Analysis 31 F-tests and t-tests will be used to analyze OV and Quality Acceptance data. The F-test is a 32 comparison of variances to determine if the OV and Quality Acceptance population variances 33 are equal. The t-test is a comparison of means to determine if the OV and Quality Acceptance 34 population means are equal. In addition to these two types of analyses, independent verification 35 and observation verification will also be used to validate the Quality Acceptance test results.

  • Drug Test Results 1. All records pertaining to department-required drug tests shall remain confidential, and shall not be provided to other employers or agencies without the written permission of the person whose records are sought. However, medical, administrative, and immediate supervisory personnel may have access to relevant portions of the records as necessary to insure the acceptable performance of the officer's job duties.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • Study Population ‌ Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).

  • SAMPLE (i) Unless agreed otherwise, wheeled or track lay- ing equipment shall not be operated in areas identified as needing special measures except on roads, landings, tractor roads, or skid trails approved under B5.1 or B6.422. Purchaser may be required to backblade skid trails and other ground disturbed by Purchaser’s Opera- tions within such areas in lieu of cross ditching required under B6.6. Additional special protection measures needed to protect such known areas are identified in C6.24.

  • COMPENSATION ANALYSIS After the expiration of the second (2nd) Renewal Term of this Agreement, if any, a Compensation Analysis may be performed. At such time, based on the reported Total Gross Revenue, performance of the Concession, and/or Department’s existing rates for similarly- performing operations, Department may choose to increase the Concession Payment for the following Renewal Term(s), if any.

  • DATA COLLECTION AND ANALYSIS The goal of this task is to collect operational data from the project, to analyze that data for economic and environmental impacts, and to include the data and analysis in the Final Report. Formulas will be provided for calculations. A Final Report data collection template will be provided by the Energy Commission. The Recipient shall: • Develop data collection test plan. • Troubleshoot any issues identified. • Collect data, information, and analysis and develop a Final Report which includes: o Total gross project costs. o Length of time from award of bus(es) to project completion. o Fuel usage before and after the project.

  • Protocol No action to coerce or censor or penalize any negotiation participant shall be made or implied by any other member as a result of participation in the negotiation process.

  • Statistical Sampling Documentation a. A copy of the printout of the random numbers generated by the “Random Numbers” function of the statistical sampling software used by the IRO.

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