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Significance was defined as p < 0.05 with two sided analysis.
Values of P < 0.05 for two sided analysis were considered significant.
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All statistical tests were two sided and statistical analysis was done with the use of SigmaStat software (Systat Software Inc., San Jose, CA, USA).
MedCalc (Mariakerke, Belgium) software was used to generate Kaplan-Meier curves and to compare TTR using two sided log-rank analysis.
In addition to descriptive analyses, we used univariate analysis two sided Student t test for continuous variables, Mann-Whitney U test for non-parametric data, and χ test for categorical data.
For all analysis a two sided p-value of less than 0.05 was considered statistically significant.
This sample size provides 80% power (alpha 0.05, two sided) to demonstrate in survival analysis a clinical significant difference of 20% in relapse/recurrence between AD versus AD+CT (relapse 50% in AD patients versus 30% in AD+CT) patients after 15 months, based on a recent meta-analysis on AD versus placebo [ 10].
The two sided versus one sided.
We used two sided significance tests throughout our data analysis.
Jonckheere-Terpstra rank-correlation test for dose-dependent efficacy indicated statistical significance (p = 0.0446 two sided) for PP but not ITT analysis (p = 0.4430 two sided).
In all inferential analysis, tests were two sided and statistical significance was set at p < 0.05.
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