---

Mini protocol sketch: all subjects sign consent, complete screening, and if eligible are randomized to Drug A or placebo. They then have treatment visits and a follow-up period. Before looking at any actual subject dates, a reviewer wants a structured picture of that planned path. Which content belongs in Trial Design datasets?

The planned design of the trial: arms, epochs, elements, visits, disease-assessment schedules, milestones, eligibility criteria, and summary facts.

Only the actual treatments each subject received.

Only adverse event coding decisions.

Only the order of datasets in the submission.