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Among these women, the risk was no different between dose groups or treatment indication groups.
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No difference in mRS or in BI was found between dose groups.
In the primary analysis, there was no statistical difference in the change from baseline in IOP at week 4 between dose groups in the worse eye (PP population) at either 8 a.m. or 4 p.m.
Our findings show a substantial variability in the amount of recombination within and between dose groups with no clear correlation between tamoxifen dose and the number of marked cells.
The PET data were analyzed for significant differences between dose groups.
Analysis of SUVmax values between dose groups on day 1 (c) and day 3 (d) of the treatment.
GE-137 has a dose-linear renal clearance, and the clearance rate was about 0.13 l/kg/h, and is comparable between dose groups.
Changes in MRI parameters between screening and 12 weeks were not significantly different between dose groups; these included median T2 lesion volume, median Gd-enhanced lesion volume, median Gd-enhanced lesion number, and mean number of newly active lesions.
Release efficiency varied between dose groups.
Because calculation of Vi requires knowledge of both vascular (99mTc-RBC) and extracellular (111In-DTPA) spaces, statistical analysis of raw %ID/g 111In-DTPA data was performed separately and showed no significant differences between dose groups (data not shown).
A group size of 10 volunteers per dose was chosen based on the distribution of antibody responses from previous clinical trials [22], [23], and would permit detection of at least a five-fold difference in antibody concentration between dose groups using a Mann-Whitney test, assuming a level of significance of 0.05 and a power of 0.80.
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