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The study data will be analysed for the primary aim.
Analyses for the primary aim will test the effect of the 3 interventions on the primary outcome measures using repeated measures analysis of covariance (ANCOVA).
The endpoint for the primary aim will be the cross-over difference of CSOR values, measured with NIRS before and at the end of the randomized feeds.
This implies that our effective sample size at the age of 6 years is sufficiently large for the primary aim of this study.
Using mean (SD) effect sizes of 6.8 (8.8) in the intervention groups and 2.0 (7.2) in the control group, there was 90% power for the primary aim with 75 participants per arm and a dropout rate of up to 20%.
Analyses relevant for the primary aim were performed first, with Group (2: ADHD and non-ADHD) as the between-group variable; and segment (5) and lag (5) as within-group variables.
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Patients who do not wish to provide stool samples but are happy to participate in all other aspects of the trial will be eligible for recruitment, as the stool samples are not necessary for answering the primary aim of the trial.
For us, the primary aim is simply fuel: we're going to need a lot of firewood to heat the house and its water in the years to come, and the perfect tree for that is ash, Fraxinus excelsior.
However, the influence of these factors is difficult to assess in a cross-sectional study for which the primary aim is to investigate the relationship between MAGE and β-cell dysfunction.
Statistical analyses for the primary aims were performed using the chi-squared test, t-test, Mann-Whitney test, nonparametric Wilcoxon matched-pairs test and analysis of variance for repeated measures.
The sample sizes for the two individual trials were calculated to obtain adequate statistical power for the primary aims of these clinical trials, not for the social support aims.
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