Appendix B. Clinical trial protocol and protocol amendment(s)

• Appendix B.
• B.1 General information
• B.2 Background information
• B.3  Trial objectives and purpose
• B.4  Trial design
• B.5   Selection of participants
• B.6  Discontinuation of trial intervention and participant withdrawal from trial
• B.7   Treatment and interventions for participants
• B.8   Assessment of efficacy
• B.9  Assessment of safety
• B.10  Statistical considerations
• B.11  Direct access to source records
• B.12  Quality control and quality assurance