Patient characteristics and neurologic data at baseline were analyzed as well as BG level and mean doses of insulin within the first five days which was considered as the acute phase of brain-injury and intra-cerebral hypertension.
In order to evaluate the gains obtained from the cooperative access scheme, the non-cooperative access scheme is analyzed as a baseline scenario, in which the PU transmits its data through the primary link directly without getting any assistance from the SU.
For the total study population: based on the assumption that the mean difference in HbA1c between two groups will be of 0.3%7.0%0% vs 6.7%) [ 2], and standard deviation of 1.05% - as analyzed at baseline – to achieve a power of 0.90 with alpha being 0.05, we would require 514 subjects to complete the study.
Data were also analyzed as ratio to baseline (day 0) at each time point to describe response magnitudes.
Clinical outcomes were analyzed as differences from baseline values (x32 - x0), and weight loss (kg) was also analyzed as a relative measure, being the percentage change from baseline ((x32 - x0)/ x0 *100%).
CIMT was analyzed as change from baseline to 12- and 50-month follow-up; a combined CIMT score was calculated as the sum of the standardized IMT scores (SD units [SDs]) of both arteries.
Measures of adiposity (BMI, waist circumference, abdominal height, percent and absolute fat, and bone mineral content [BMC] and density [BMD]) were analyzed as change from baseline at 6 and 24 months.
Univariate analyses of the combined placebo-treated and adalimumab-treated groups showed that baseline CRP (whether analyzed as a continuous or a dichotomous variable), baseline mTSS, and baseline JE and JSN scores were each predictive (P < 0.05) of radiographic progression (Table 2).
HbA1c, BMI, and glycemic failure were analyzed as time-dependent covariates, baseline age as a continuous variable, and other covariates (treatment arm, sex, and race/ethnicity) as categorical variables.
