What we see

The audit keeps pharmacokinetics, clinical events, reporting signals and patient experience separate. They may support each other, but they are not the same evidence layer.

What limits it

The conclusion must not outrun the material. Sex must neither be ignored nor used as a mechanism on its own.

Questions asked by the audit

Continue to documentation

See the cross-cutting findings, method boundaries and complete working package containing all ten gates and three full audits.