Multiplicity Adjustment Sample Clauses

Multiplicity Adjustment. No formal multiplicity adjustment will be performed. All efficacy analyses will be considered descriptive. Ninety-percent confidence intervals will be provided for each treatment group and nominal p-values from comparisons to placebo may be provided for descriptive purposes. The nominal p-values will be tested using a hierarchical testing strategy using 2-sided tests with significant level α = 0.10. Nominal p-values will be provided for all secondary efficacy analyses as a measure of the strength of the association between the endpoint and the treatment effect rather than formal tests of hypotheses.