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The distribution of the department units in experimental and comparison groups will be made after the baseline data analysis, in close consultation with the hospital management.
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For the subgroup of people with HbA1c ≥ 7%: assuming the difference of 0.4% between the control and intervention group (7.8% vs 7.4%) [ 4] and the standard deviation of 0.94% as observed within this subgroup at the baseline data analysis, we would need 232 people in both arms to achieve a power of 0.90 in this subgroup.
Table 3 shows the effect of Se v. placebo supplementation on sFlt-1 concentration at 35 weeks in participants in the bottom quartile and tertile of whole-blood Se at baseline (primary data analysis of the present study) and in the whole dataset.
Missing continuous outcome data were not addressed appropriately (either not addressed at all or use of baseline data carried forward analysis) in four studies.
We conducted a secondary analysis of baseline data obtained in our NIH-funded, randomized trial that compared Tai Chi and physical therapy among individuals with symptomatic knee osteoarthritis (Trial Registry #NCT01258985) [ 20].
The sociodemographic characteristics of the 3331 women and included in the factor analysis of baseline data are shown in Table 1.> The responses to the POSM questions are summarised in Additional file 1.
Since this review used only baseline data in the meta-analysis, all data were unadjusted with the exception of left ventricular mass adjusted for height.
Baseline data were entered in the analysis as co-variates.
Finally, descriptive results from this study should be interpreted as baseline data for subsequent in depth analysis and longitudinal investigation.
> For the primary outcomes, patients with data available for Week 9 or 26 but with missing baseline data were included in the analysis to avoid violating the intention-to-treat principle.
Further analysis on baseline data is recommended in order to determine the cause of the high incidence and severity of diarrhoea in the treated Caucasian population, compared to previous Japanese data.
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