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There was no statistically significant difference in primary patency between the dose groups (placebo n=21, Low Dose n=16, Medium Dose n=17 and High Dose n=12).
The study sample size was designed to be able to detect large differences in the frequency of adverse events between the dose groups.
As expected, the mean AUC and Cmax increased with increasing dose, although there was overlap between the dose groups.
No clinically relevant difference in reduction of UI episodes was observed between the dose groups in either etiology.
No formal determination of sample size was performed and no formal statistical comparisons were made between the dose groups.
The differences in mean baseline CSF Aβ levels observed between the dose groups were most likely due to chance resulting from the small sample size.
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This approach does not account for multiple comparisons between each of the dose groups and the control group.
In addition to performing a trend test, scientists at the NTP are often interested in performing pairwise comparisons between each of the dose groups and the control group.
We also developed an order-restricted inference-based procedure for performing multiple pairwise comparisons between each of the dose groups and the control group.
In addition to testing for dose-related trends, NTP performs pairwise comparisons between each of the dose groups and the control group, with particular attention paid to the medium- and high-dose groups.
There were also some baseline differences between the dosing groups in some B cell measurements.
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