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The comparator may be placebo, when ethical andor feasible, or an active control for a fuler trial. Non-inferiority trial design is acceptable against an approved agent as long as a meaningful inferiority margin can be identified and assay sensitivity is alleegra. The lack of contemporary placebo-controlled trials of BCG makes it difficult to determine inferiority margins for a time-to-event, recurrence-free survival, non-inferiority trial against BCG. Trials that include patients with pure papillary disease should use recurrence-free survival as the primary endpoint. Events include any recurrence within the bladder or prostatic urethra.

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