Analysis of Primary Endpoints Sample Clauses

Analysis of Primary Endpoints. Part A CORE Study Sweat chloride by cohort will be summarized using repeated measures ANOVA, including means and 95% confidence intervals. Global tests for difference between cohorts and pair- wise tests will also be performed. Part A pH pill Sub-study Summary statistics and 95% confidence intervals will summarize pH in the first 30 minutes between subjects in Cohort 2 to those in Cohort 3, and tested with a two-sample t-test. Part B CORE Study Change in FEV1 from Baseline to Visit 7 among those who took lumacaftor/ivacaftor in Part B will be summarized and tested via paired-t test and longitudinal mixed effect modeling adjusted for baseline FEV1 and age. Part B GIFT Sub-study For the glucose/insulin functional testing: summary statistics and 95% confidence intervals will be summarized for changes in area under the insulin and c-peptide curves from Baseline to Visit 5, and tested via the paired t-test. Estimates of mean AUCs and changes from Baseline at each subsequent Visit will be obtained by repeated measures ANOVA. For the gastro-intestinal functional testing: the percent of subjects with negative breath test at Visit 5 among those positive at Baseline will be estimated with 95% CI (Xxxxxx’x score- based). Part B pH pill Sub-study Summary statistics and 95% confidence intervals will be presented. A paired t-test will be used to compare the change in pH (during initial 30 minutes) from Baseline to Visit 5. Part B MBW/FENO Sub-study For MBW: Summary statistics and 95% confidence intervals will be presented for change in LCI. A paired t-test will be performed to compare Visit 7 LCI measurements to baseline. Changes in LCI across all time points will be assessed by generalized estimating equations. Feasibility will be assessed as the percentage of subjects producing research quality measurements for the primary study endpoint (both baseline and Visit 7) and at each time point. For FENO: Summary statistics and 95% confidence intervals will be presented for change in FENO. A paired t-test will be performed to compare Visit 5 measurements to baseline. Changes in FENO across all time points will be assessed by generalized estimating equations. Part B MCC Sub-study Summary statistics and 95% confidence intervals will summarize change in average whole lung clearance from Baseline to Visit 5, and tested with a paired t-test.
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Related to Analysis of Primary Endpoints

  • Analysis LICENSEE represents and agrees that it will only incorporate Components received from authorized suppliers into Licensed Products and for no other purpose, and that LICENSEE will not directly or indirectly attempt to reverse-engineer any material provided to it hereunder by LICENSEE or any supplier of any Component.

  • Maintenance and Testing 54.5.1. Sprint is only responsible for maintaining the facilities that it owns.

  • Disturbance Analysis Data Exchange The Parties will cooperate with one another and the NYISO in the analysis of disturbances to either the Large Generating Facility or the New York State Transmission System by gathering and providing access to any information relating to any disturbance, including information from disturbance recording equipment, protective relay targets, breaker operations and sequence of events records, and any disturbance information required by Good Utility Practice.

  • 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

  • Audit and Testing 4.1 The Contractor shall conduct tests of the processes and countermeasures contained in the Security Plan ("Security Tests") on an annual basis or as otherwise agreed by the Parties. The date, timing, content and conduct of such Security Tests shall be agreed in advance with the Authority.

  • 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.

  • Inspections and Testing Each Interconnected Entity shall perform routine inspection and testing of its facilities and equipment in accordance with Good Utility Practice as may be necessary to ensure the continued interconnection of the Customer Facility with the Transmission System in a safe and reliable manner. Each Interconnected Entity shall have the right, upon advance written notice, to request reasonable additional testing of an Interconnected Entity’s facilities for good cause, as may be in accordance with Good Utility Practice.

  • Basis of compilation This statement of eligible expenditure has been prepared to meet the requirements of the grant agreement between [enter Grantee name] and the Commonwealth represented by the Department of Industry, Science, Energy and Resources. Significant accounting policies applied in the compilation of the statement of grant income and expenditure include the following: [enter details] Certification by directors [if not director, replace with appropriate equivalent] [Grantee name] [Project number] For the period [dd/ mm/yyyy] to [dd/ mm/yyyy] We confirm that, to the best of our knowledge and believe, having made such enquiries as we considered necessary for the purpose of appropriately informing ourselves: Statement of grant income and expenditure We have fulfilled our responsibilities for the preparation of the statement of grant income and expenditure in accordance with the cash basis of accounting and the terms of the grant agreement with the Commonwealth, represented by the Department of Industry, Science, Energy and Resources dated [enter date]; in particular, the statement of grant income and expenditure presents fairly in accordance therewith. All events subsequent to the date of the statement of grant income and expenditure which require adjustment or disclosure so as to present fairly the statement of grant income and expenditure, have been adjusted or disclosed. [Where applicable] The effects of uncorrected misstatements are immaterial, both individually and in the aggregate, to the statement of grant income and expenditure as a whole. A list of the uncorrected misstatements is attached to this representation letter. That all Grantee contributions and other financial assistance were spent for the purpose of the project and in accordance with the grant agreement and that the Grantee has complied with the grant agreement and relevant accounting policies. That salaries and allowances paid to persons involved in the project are in accordance with any applicable award or agreement in force under any relevant law on industrial or workplace relations. Signature Name [enter name] Director Date [dd/mm/yyyy] Signature Name [enter name] Director Date [dd/mm/yyyy] For Auditor use only I certify that this statement of grant income and expenditure is the one used to prepare my independent audit report dated [enter date] for the Department of Industry, Science, Energy and Resources. Signature Name [enter name] Position [enter position] Auditor’s employer [enter employer name] Date [dd/mm/yyyy] Attachment B - Independent audit report Background for auditors The purpose of the independent audit report is to provide us with an auditor's opinion on the Grantee’s statement of grant income and expenditure. The statement of grant income and expenditure is prepared by the Grantee to correspond with the expenditure reported to the department by the Grantee for the same period, in the process of claiming grant payments. The independent audit report must be prepared by a person who is an approved auditor. An approved auditor is a person who is: registered as a company auditor under the Corporations Xxx 0000 or an appropriately qualified member of Chartered Accountants Australia and New Zealand, or of CPA Australia or the Institute of Public Accountants; and not a principal, member, shareholder, officer, agent, subcontractor or employee of the Grantee or of a related body corporate or a Connected Entity. The audit should be undertaken and reported in accordance with Australian Auditing Standards. The independent audit report must follow the required format and include any qualification regarding the matters on which the auditor provides an opinion. We may follow up any qualifications with the Grantee or auditor. The independent audit report must be submitted on the auditor's letterhead. Auditors must comply with the professional requirements of Chartered Accountants Australia and New Zealand, CPA Australia and the Institute of Public Accountants in the conduct of their audit. If the auditor forms an opinion that the statement of grant income and expenditure does not give a true and fair view of the eligible expenditure for the period, the independent audit report should be qualified and the error quantified in the qualification section of the independent audit report. The required independent audit report format follows. Auditor’s report Independent audit report in relation to [Grantee name]’s statement of grant income and expenditure to the Commonwealth, represented by the Department of Industry, Science, Energy and Resources (the department). We have audited: the accompanying statement of grant income and expenditure of [Grantee name] for the period [dd/mm/yyyy] to [dd/mm/yyyy], a summary of significant accounting policies and other explanatory information, and management’s attestation statement thereon (together “the financial statement”). The financial statement has been prepared by management using the cash basis of accounting described in note 3.2 to the financial statement; and [Grantee name]'s compliance with the terms of the grant agreement between [Grantee name] and the Commonwealth dated [date of agreement] for the period [dd/mm/yyyy] to [dd/mm/yyyy] (the grant agreement). We have: reviewed [Grantee name]’s statement of labour costs in support of its claim of eligible expenditure[; and performed limited assurance procedures on [Grantee name]’s statement of employee numbers under the grant agreement]. Management’s responsibility Management is responsible for: the preparation and fair presentation of the financial statement in accordance with the basis of accounting described in note 3.2, this includes determining that the cash basis of accounting is an acceptable basis for the preparation of the financial statement in accordance with the grant agreement; compliance with the terms of the grant agreement; the preparation of the statement of employee numbers and labour costs in support of eligible expenditure; and such internal control as management determines is necessary to: enable the preparation of the financial statement and the statement of [employee numbers and ]labour costs that are free from material misstatement, whether due to fraud or error; and enable compliance with the terms of the grant agreement. Auditor’s responsibility Our responsibilities are: To express an opinion, based on our audit, on: the financial statement; and [Grantee name]’s compliance, in all material respects, with the terms of the grant agreement; and To conclude based on: our review procedures, on the statement of labour costs; and our limited assurance procedures on the statement of employee numbers. We conducted our audit of the financial statement in accordance with Australian Auditing Standards; our audit of compliance with the grant agreement in accordance with ASAE 3100, our review of the statement of labour costs in accordance with ASRE 2405[; and our limited assurance procedures on employee numbers in accordance with ASAE 3000]. The applicable Standards require that we comply with relevant ethical requirements and plan and perform our work to: obtain reasonable assurance about whether the financial statement is free from material misstatement and that [Grantee name] has complied, in all material respects, with the terms of the grant agreement; and obtain limited assurance as to whether anything has come to our attention that causes us to believe that the statements of employee numbers and labour costs are materially misstated. An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the financial statement and about the Grantee’s compliance with the grant agreement. The procedures selected depend on the auditor’s judgement, including the assessment of the risks of material misstatement of the financial statement, whether due to fraud or error. In making those risk assessments, the auditor considers internal control relevant to the Grantee’s preparation and fair presentation of the financial statement, and to the Grantee’s compliance with the grant agreement, in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Grantee’s internal control. An audit also includes evaluating the appropriateness of accounting policies used by management, as well as evaluating the overall presentation of the financial statement.

  • 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.

  • STATEMENT OF PHILOSOPHY The University of Minnesota and the Union are committed to recognizing and acknowledging the healthy and positive diversity that we have on the University campuses. Further, the parties recognize that all employees have the right to work in a productive environment in which there is no verbal or physical intimidation, or discrimination or harassment based on the criteria provided in Section 1, Discrimination Prohibition, and Section 2, Sexual Harassment. It is in this spirit that the parties agree to the provisions of this Article. This statement shall not be grievable nor shall either party use this Section as evidence or argument in arbitration.

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