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The level of significance for all analyses will be a priori established at 0.05 using a two-tailed test.
That said, our study demonstrates that experimental infections combined with behavioral studies to determine sampling points followed by mixed transcriptomics analyses will be a good approach to study the parasite-host interactions at these earlier stages as well.
The outcome of the phase I analyses will be a set of "signatures" that use in vitro screening data as inputs to predict in vivo toxicology phenotypes with high enough sensitivity and specificity to be useful for prioritization for more detailed testing.
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The primary independent variable in the regression analyses will be an indicator variable for intervention group.
The annotated ΨEs that we have analysed will be a fertile source for study using large-scale micro-array expression techniques for these two potential regulatory functions.
Statistical analyses will be described a priori in a Statistical Analysis Plan, and the principal analyses will be implemented independently by two statisticians.
Data analyses will be performed a statistician using Stata version 13 software.
Two analyses will be performed: an intention-to-treat analysis (ITT) and a per-protocol analysis (PP).
Analyses will be on an intention-to-treat (ITT) basis.
All analyses will be on an intention-to-treat basis.
All these analyses will be on an ITT basis and will adjust for minimisation variables.
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