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In relation to the trial hypotheses, each intervention group will be compared to the standard care group using intention to treat analysis.
DNA based risk assessments had no significant effects on either primary or secondary outcomes and none of the trial hypotheses was supported.
The same modeling approach will be used to evaluate the trial hypotheses over all sites combined, while controlling for research site.
In relation to the trial hypotheses, the intervention group will be compared to the control group by intention to treat analysis.
We suggest that a combination of basic and clinical science, together with the kind of bio-systems modeling presented here, could be used to "pre-test" proposed trial hypotheses, thereby limiting the risk of negative, inconclusive, or adverse trial outcomes.
In relation to the trial hypotheses, each intervention group will be compared with the group of women allocated to standard care by intention to treat analysis, which will also adjust for any "cluster" effect within classes.
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The trial hypothesis that TCH was superior to ACTH was not proven and, since the study was not powered to detect equivalence between ACTH and TCH, this conclusion cannot be drawn.
Typically, investigators rely on results from previous trials or observational studies and use statistical modeling of disease incidence and other factors, such as participant compliance and attrition, to design a protocol with power sufficient to test the trial hypothesis [ 1, 2].
Merck's longstanding policy is to publish the results of clinical trials that test hypotheses concerning drug safety or effectiveness, regardless of outcome.
Every experiment starts with a hypothesis and we trial the hypothesis, review the results and make assumptions on a better solution without any guarantee that the hypothesis was correct.
Exploratory early phase trials are hypothesis forming, not hypothesis testing.
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