= Solution
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 https://www.wma.net/policies-post/wma-declaration-of-helsinki/[the Declaration of Helsinki].
\b[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.
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