What's included

The gates confirmed before lock

• Zero open queries confirmed across the entire database, verified through final data cleaning
• SAE reconciliation sign-off obtained, confirming safety data matches the clinical database
• Coding completion confirmed for all AE, medical history, and concomitant medication terms
• Lock readiness reviewed and approved per the data management plan's sign-off requirements
• Database locked with edit access removed, so any post-lock change requires a formal, documented amendment