Guidance Sheets
- Guidance Sheet 01: Recruitment and eligibility criteria
- Guidance Sheet 02: Obtaining Informed Consent
- Guidance Sheet 03: Randomisation of women into the trial
- Guidance Sheet 04: Trial Intervention
- Guidance Sheet 05: Entering a woman on the ANODE randomisation program
- Guidance Sheet 06: Safety Monitoring
- Guidance Sheet 07: Procedures for Emergency Queries
- Guidance Sheet 08: Trial IMP Reconciliation
- Guidance Sheet 09: Data Collection Forms
- Guidance Sheet 10: Incident Reporting and Withdrawal
- Guidance Sheet 11: IMP Management and Stock Control