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Valid Analysis: An unbiased assessment that will, on average, yield the correct estimate of the difference in outcomes between two groups of subjects. Valid analysis can and should be conducted for small and large studies. A valid analysis need not have a high statistical power for detecting a stated effect. The principal requirements for ensuring a valid analysis of the question of interest are: Allocation of study participants of both sexes/genders and from different racial/ethnic groups to the intervention and control groups by an unbiased process such as randomization; unbiased evaluation of the outcome(s) of study participants; and use of unbiased statistical analyses and proper methods of inference to estimate and compare the intervention effects among the gender and racial/ethnic groups.
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