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The investigators will conduct rigorous analyses of trial participants' blood, brain function and cerebral spinal fluid in an effort to find factors that correlate with migraine susceptibility, severity and frequency.
No interim or subgroup analyses of trial outcomes are planned.
Mixed models have been recommended for analyses of trial data (Gueorguieva & Krystal, 2004).
The Committee will determine if additional interim analyses of trial data should be undertaken.
The authors conducted subgroup analyses of trial participants who had cervices unfavorable for induction.
In post hoc analyses of trial data, subgroup results by QRS duration have led to mixed conclusions.
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Although subgroup analyses of trials, which can often factor into evidence-based guidelines, attempt to systematically identify characteristics of patients who may uniquely benefit, these analyses can be insufficient, underpowered, misleading, or misinterpreted.
For all analyses of trial-by-trial interactions, the number of significant effects found was less than what would be expected by chance (i.e. <5%).
However, no increased risk was reported in pooled analyses of trials using budesonide [ 17].
Additionally, several trials were limited by retrospective data collection and post-hoc analyses of trials with non-respiratory outcomes [ 12- 14].
15 We carried out subgroup analyses of trials with the different anticoagulants as well as in hip and knee replacement.
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