Here we present the primary analysis of this study.
Since we are using an Analysis of Covariance (ANCOVA) to perform data analysis (primary analysis), this sample size estimation may be considered conservative.
Although not featured as part of the primary analysis, profound changes in size and morphology were also found in the pectoral girdles (e.g., glenoid width and depth) and pelvic girdles (e.g., acetabular width and depth) of both alligators and ostrich, indicating that these joints are also built by large amounts of articular cartilage.
32 The primary analysis will compare the size of pressure ulcers in the Control (usual community care) and Intervention (telephone-based support) groups at 12 weeks.
To determine the risk of RCTs to be discontinued for any reason and for specific reasons including futility, adverse events, early superiority of one intervention, and insufficient recruitment (defined for primary analysis as <90% of the planned sample size achieved, and for secondary analysis as <80%).
The Monte Carlo method used in this analysis is considered highly reliable for evaluating the effects of a variable on the results of an analysis or on stability testing of results and conclusions of the primary analysis, and the large sample size used permitted the demonstration of high repeatability and statistical significance of the results.
Secondary outcomes also have less external validity than the primary analysis, and differences in the size of included studies could mask differences in the size of the analyses.
Acknowledging this limitation, we included 2004 data in our primary analysis in order to maximize our sample size.
For purposes of a primary analysis, this approach is reasonable.
The effect size for this set of studies was 0.19 (-0.01-0.39, random model) which was not significantly different (p=0.67) from the primary analysis (in Figure 5).
A sample size of 160 provided 80% power to detect a minimum effect size of 0.5 standard deviations difference in the mean daily cry or fuss time between treatment groups with a significance level of P<0.05, allowing for a dropout rate of 20% (target sample size of 128 for primary analysis).
