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.