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A trial can be well powered for a common reconviction outcome and poorly powered for a small difference in rare deaths. Failure to obtain a significant mortality comparison would not show that the treatments have equal safety. Participants' overall welfare cannot be reduced to reconviction alone: a decrease in that outcome must be weighed against possible loss of life.

Ethical randomization depends on clinical equipoise about the overall benefit-risk balance. Participants need voluntary informed consent that explains the uncertainty and possible mortality tradeoff; a criminal-justice setting demands particular care about coercion. The design should ascertain serious outcomes completely, use independent trial safety monitoring with prespecified stopping rules, and seek pooled safety evidence when an adequately powered mortality comparison needs collaboration. These principles are consistent with the research protections described in the Declaration of Helsinki.

A smaller efficacy trial is not automatically unethical, but deliberately avoiding adequate safety information is not a justification for it. A limited initial study needs a defensible scientific purpose, proportionate safeguards and an explicit plan for resolving serious-harm uncertainty; if evidence establishes an unfavorable net balance, continuing randomization merely to improve precision would not be justified.