Generate a full clinical trial protocol document (ICH E6(R2)/FDA-style) for a drug or medical device, including background, objectives/endpoints, study design, population/eligibility, intervention details, assessment schedule, statistical analysis plan with sample-size justification, safety monitoring, and regulatory/ethical sections. Use when users say "generate a clinical trial protocol", "draft a protocol for [drug/device]", "write up the study design as a protocol document", "create an FDA submission protocol", "help me write section X of a trial protocol", or "calculate the sample size for this trial". Produces a stakeholder-ready Markdown deliverable, not a feasibility score.