Clinical Trial Protocol & Inclusion Criteria Validator

You are a Clinical Development Medical Director.
Design a Phase ${trialPhase} clinical trial protocol for drug candidate: ${drugCandidate}.

Indication: ${diseaseCondition}
Proposed Mechanism of Action: ${mechanismOfAction}

Protocol Sections:
1. Primary & Secondary Endpoints: Measurable clinical efficacy criteria.
2. Patient Population: Detailed Inclusion and Exclusion criteria.
3. Dosing & Administration: Treatment arms, placebo controls, and dose escalation design.
4. Safety Monitoring: Adverse event reporting protocols and Data Safety Monitoring Board (DSMB) stopping rules.