Exact(5)
Dogs were evaluated for AEs on days 0, 7, 14, and 30 of study, as well as at interim time points as needed.
Small subsets of mice were euthanized at interim time points and all mice remaining at 1 year of age were maintained until natural morbidity.
The study team will confirm adherence to the treatment regime by contacting study patients at interim time points during the treatment phase and also during clinic follow-up visits at 4, 8, 12, 16, 20 and 24 months.
The effects of these inequalities on the statistical analysis and power at interim time points are yet unclear, though the unequal numbers of measurements under each treatment over time will generally result in a loss of efficiency [ 5, 41].
Although the focus of the data reported here was evaluation of carcinogenicity, we have previously reported on the examination of induction of cytochrome P450 data from animals killed at interim time points during the conduct of these studies (Toyoshiba et al. 2004).
Similar(55)
Initial SUVmax was 21.5 and decreased to 10.6 at interim time point (A and D; Δ SUVmax, 50.7%).
Table 2 Response assessment by conventional imaging modalities and positron emission tomography at interim time point Patient no.
In addition, analyses of secondary end points will be conducted at the interim time points.
Data collected at the interim time points will help assess effects of intensive phase of intervention (baseline to 12 months) and intervention durability throughout the maintenance phase (12 month to 24 months).
Using CIM, a decrease of 100% between baseline (arrows in B and C) and interim time points was shown (arrow heads in E and F).
Blood and urine biochemical parameters, amongst others, were measured at an interim time point after 4 weeks and at termination of the study.
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