Analysis Populations Sample Clauses

Analysis Populations. Intent-to-treat (ITT) and safety populations: All subjects who are randomized, take one or more doses of study medication and have at least one post dosing assessment will be included in the ITT (efficacy assessment) and safety (safety assessment) populations. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Analysis Populations. Intent-to-treat (ITT) and safety populations: All subjects who are randomized, take one or more doses and have at least one post dosing assessment will be included in the ITT and safety populations.
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Analysis Populations. The population valid for the safety analysis will be comprised of all patients who received treatment with IRE. Patients who received at least one treatment with IRE will be valid for safety analysis.
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Analysis Populations. ‌ Three different analysis populations will be used for analysis of data from this study, as described below: • Randomized: This population will be comprised of all subjects who were initially randomized. This population will be used for summaries of subject disposition and baseline subject characteristics. • Intent-to-treat (ITT)/Safety: This population will be comprised of all subjects who were initially randomized and received at least one dose of study drug. This will be the primary population for all summaries of subject disposition and baseline characteristics, efficacy analyses, and safety analyses for purposes of regulatory submissions. • Modified Intent-to Treat (m-ITT): This population will be comprised of all randomized study subjects who receive study treatment and return for at least one post-randomization assessment of height and weight. This population will be used for the analysis of all efficacy variables for all other purposes, including but not limited to publications, presentations, and robustness of sensitivity of analyses.
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Analysis Populations. The Total Population will comprise all subjects screened and for whom a record exists on the study database. The Safety population will consist of all subjects who were randomised to treatment and who received at least one dose of trial medication. Randomised subjects will be assumed to have received trial medication unless definitive evidence exists to the contrary. If any subjects have inadvertently received a different treatment for the duration of the study, or were inadvertently given more than one treatment, their data will be assigned to the treatment group to which they took for the majority (i.e. >50%) of the treatment period. This population will form the primary population for analyses of safety data The Intent-to-Treat – Efficacy (ITT) population will consist of all subjects in the Safety Population, with the exception of subjects recruited at sites which were closed down as the result of audit findings or other information which implied that the integrity of the data had been compromised. These subjects will be excluded from the ITT population (and all efficacy analyses), and this decision will be formally documented prior to unblinding of the trial.. The ITT Population follows the intention-to-treat principles defined in the ICH E9 guidelines [The European Agency for the Evaluation of Medicinal Products, 1998]. Following these principles, if any subjects have inadvertently received a different treatment for the duration of the study, or were inadvertently given more than one treatment, their data will be assigned to the treatment group to which they were originally randomised, irrespective of which treatment they actually took. This population will form the primary population for analysis of efficacy measures, including mortality, and for analyses of health outcomes measures. The Health Outcomes Population will be a subset of the Intent-to-Treat – Efficacy Population, and will consist of subjects participating in countries where SGRQ questionnaire translations are linguistically valid for the population, and who have completed at least one questionnaire. If any subjects have inadvertently received a different treatment for the duration of the study, or were inadvertently given more than one treatment, their data will be assigned to the treatment group to which they were originally randomised, irrespective of which treatment they actually took. This population will be used for all analyses and listings pertaining to health outcomes related to ...
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Analysis Populations. The Safety Population will include all subjects who receive at least 1 dose of study drug. The PK Population will include subjects who receive study drug and have sufficient concentration data to facilitate the calculation of PK variables.
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Analysis Populations. The following analysis populations will be used:
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Related to Analysis Populations

  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

  • Quantitative Analysis Quantitative analysts develop and apply financial models designed to enable equity portfolio managers and fundamental analysts to screen potential and current investments, assess relative risk and enhance performance relative to benchmarks and peers. To the extent that such services are to be provided with respect to any Account which is a registered investment company, Categories 3, 4 and 5 above shall be treated as “investment advisory services” for purposes of Section 5(b) of the Agreement.”

  • Tests 7.7.1 If the Contract Documents, laws, ordinances, rules, regulations or orders of any public authority having jurisdiction require any portion of the Work to be inspected, tested or approved, the Contractor shall give the Architect timely notice of its readiness so the Architect may observe such inspection, testing or approval. The Contractor shall bear all costs of such inspections, tests or approvals conducted by public authorities.

  • Data To permit evaluation of requests under paragraph (c) of this clause based on unreasonable cost, the Contractor shall include the following information and any applicable supporting data based on the survey of suppliers: Foreign and Domestic Construction Materials Cost Comparison Construction material description Unit of measure Quantity Cost (dollars) * Item 1: Foreign construction material Domestic construction material Item 2 Foreign construction material Domestic construction material [List name, address, telephone number, and contact for suppliers surveyed. Attach copy of response; if oral, attach summary.] [Include other applicable supporting information.] (*Include all delivery costs to the construction site.]

  • ANALYSIS AND MONITORING The Custodian shall (a) provide the Fund (or its duly-authorized investment manager or investment adviser) with an analysis of the custody risks associated with maintaining assets with the Eligible Securities Depositories set forth on Schedule B hereto in accordance with section (a)(1)(i)(A) of Rule 17f-7, and (b) monitor such risks on a continuing basis, and promptly notify the Fund (or its duly-authorized investment manager or investment adviser) of any material change in such risks, in accordance with section (a)(1)(i)(B) of Rule 17f-7.

  • Stability 14.01 Maintain a documented, ongoing stability program to monitor the stability of the Product using stability indicating procedures. X 14.02 Data analysis and trending reporting will be performed. X

  • Risk Analysis The Custodian will provide the Fund with a Risk Analysis with respect to Securities Depositories operating in the countries listed in Appendix B. If the Custodian is unable to provide a Risk Analysis with respect to a particular Securities Depository, it will notify the Fund. If a new Securities Depository commences operation in one of the Appendix B countries, the Custodian will provide the Fund with a Risk Analysis in a reasonably practicable time after such Securities Depository becomes operational. If a new country is added to Appendix B, the Custodian will provide the Fund with a Risk Analysis with respect to each Securities Depository in that country within a reasonably practicable time after the addition of the country to Appendix B.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

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