Primary Study Efficacy Analysis Sample Clauses

Primary Study Efficacy Analysis. The primary objective of this study is to determine if treatment with magnesium sulfate improves the long-term functional outcome of hyperacute stroke patients. The primary endpoint that will be examined will be modified ▇▇▇▇▇▇ Scale scores assessed 3 months poststroke. Data will be analyzed to test the null hypothesis that the distribution of scores on the modified ▇▇▇▇▇▇ Scale at Day 90 is identical in the magnesium sulfate and placebo groups, versus the one-sided alternative that the distribution of scores is shifted lower in the active magnesium sulfate therapy group. The statistic used to test the primary hypothesis will be the ▇▇▇▇▇▇▇-▇▇▇▇▇▇-Haenszel test statistic performed on the rank scores and stratified by transport vehicle. The criterion for statistical significance will be set at an alpha level of 0.05. The rank based ▇▇▇▇▇▇▇-▇▇▇▇▇▇-Haenszel test is designed to test against the alternative that there is a uniform shift of size “delta” in the ▇▇▇▇▇▇ score distribution from one group to the other after stratification by other factors. We will compare the two cumulative distribution functions (CDFs) and carry out the ▇▇▇▇▇▇▇ procedure to determine if this alternative is reasonable. [16] If not, we will consider more robust test procedures such as the Kolmogorov- Smirnov (K-S) test. The K-S procedure is also rank-based and tests against a general alternative to the null hypothesis instead of a more restrictive delta shift alternative.
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Related to Primary Study Efficacy Analysis

  • 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.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be or have been submitted to FDA or other comparable governmental entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, applicable Authorizations, and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and, for studies submitted to regulatory authorities for approval, in all material respects, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete and fairly present the data derived from such studies and trials in all material respects; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes materially call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

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  • 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.”