3.15 Follow-up and monitoring 16 3.16 Specimen storage, handling and transport 20 3.17 Diagnostic assays and laboratory methods 20 4. Pharmacokinetic sub-study 21 5. Pre-specified study endpoints 22 5.1 Primary endpoint: 22 5.2 Secondary endpoints: 23 6. Data management and statistical analysis 23 6.1 Data management 23 6.2 A priori statistical analysis plan 24 7. Justification of study 26 7.1 Choice of treatment arms 26 7.2 Inclusion of a delayed PQ arm 26 7.3 Follow-up duration 26 7.4 Choice of endpoints 27 7.5 Sample size calculation and statistical power 27 7.6 Feasibility and logistics 28 8. Ethical considerations 29 8.1 Potential benefits to participants 29 8.2 Potential risks to participants 29 9. Quality assurance, reporting and risk management 30 9.1 Identified risks and mitigation strategy: 30 9.2 Quality assurance activities 32 9.3 Data and Safety Monitoring Board (DSMB) 33 9.4 Reporting to Sponsor 34 10. Dissemination of results 34 10.2 Publication plan and data sharing 34 11. Project team and governance structure 34 PART 5: PARTNERSHIPS AND LEVERAGE 36 1. Participating institutions 36
3.15 Follow-up and monitoring 16 3.16 Specimen storage, handling and transport 20 3.17 Diagnostic assays and laboratory methods 20 4. Pharmacokinetic sub-study 21 5. Pre-specified study endpoints 22 5.1 Primary endpoint: 22 5.2 Secondary endpoints: 23 6. Data management and statistical analysis 23 6.1 Data management 23 6.2 A priori statistical analysis plan 24 7. Justification of study 26 7.1 Choice of treatment arms 26 7.2 Inclusion of a delayed PQ arm 26 7.3 Follow-up duration 26 7.4 Choice of endpoints 27 7.5 Sample size calculation and statistical power 27 7.6 Feasibility and logistics 28 8. Ethical considerations 29 8.1 Potential benefits to participants 29 8.2 Potential risks to participants 29 9. Quality assurance, reporting and risk management 30 9.1 Identified risks and mitigation strategy: 30 9.2 Quality assurance activities 32 9.3 Data and Safety Monitoring Board (DSMB) 33 9.4 Reporting to Sponsor 34 10. Dissemination of results 34 10.2 Publication plan and data sharing 34 11. Project team and governance structure 34 PART 5: PARTNERSHIPS AND LEVERAGE 36 1. Participating institutions 36
372150-ACT-Radical%20Solomons%20protocol%20v1.0.docx