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The report was uncontrolled, unblinded, not randomized, had no comparator arm, used patient-reported outcomes rather than validated pain instruments, and did not publish dose, effect size, confidence intervals, p-values, or systematically collected adverse events limitations that severely constrain any clinical inference

Why Traditional Site Selection Struggles Historically, site selection has relied heavily on: investigator networks CRO feasibility surveys historical trial relationships But these approaches often concentrate trials around the same academic institutions and urban research centers

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