2.6. Statistical Analysis
In order to initially calculate the sample size required for this study, we first posited that the mortality of the study group with safflower yellow intervention would be 30% lower than the control group. We used data from a previous septic sepsis trial with 52.5% mortality in the control group [24]. Assuming a rate of patient withdrawal from the trial of 20%, to achieve a two-sided type I error rate of 5% and a power of 80%, we calculated that a sample size of 100 patients was required to detect differences in mortality between these two groups. Numbers (%) for categorical variables were compared using Pearson chi-square test or Fisher’s exact test. Normally distributed continuous variables were presented as mean ± standard deviation. Statistical significance was determined by Pearson chi-square test, Student’s -test, Wilcoxon Rank-Sum Test, and Log Rank Kaplan-Meier analyses. values less than 0.05 were considered to be significant. The Statistical Package for the Social Sciences (SPSS) version 17.0 (SPSS Inc., Chicago, IL, USA) was used for analysis.
2.6. Statistical AnalysisIn order to initially calculate the sample size required for this study, we first posited that the mortality of the study group with safflower yellow intervention would be 30% lower than the control group. We used data from a previous septic sepsis trial with 52.5% mortality in the control group [24]. Assuming a rate of patient withdrawal from the trial of 20%, to achieve a two-sided type I error rate of 5% and a power of 80%, we calculated that a sample size of 100 patients was required to detect differences in mortality between these two groups. Numbers (%) for categorical variables were compared using Pearson chi-square test or Fisher’s exact test. Normally distributed continuous variables were presented as mean ± standard deviation. Statistical significance was determined by Pearson chi-square test, Student’s -test, Wilcoxon Rank-Sum Test, and Log Rank Kaplan-Meier analyses. values less than 0.05 were considered to be significant. The Statistical Package for the Social Sciences (SPSS) version 17.0 (SPSS Inc., Chicago, IL, USA) was used for analysis.
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