Manual of Procedures for the Phase 2 Study

  1. SUMMARY OF THE PHASE 2 PROTOCOLS
  2. SPECIFIC AIMS AND OBJECTIVES/HYPOTHESES
  3. SOURCES OF DATA
  4. RECRUITMENT PROCEDURES
  5. SCREENING PROCEDURES
  6. BASELINE ACTIVITIES
  7. RANDOMIZATION AND BLINDING
  8. FOLLOW-UP EVALUATIONS
  9. EVALUATION PROTOCOLS
  10. DLW PROCEDURES AT THE SITES
  11. BLOOD COLLECTION FOR CENTRAL BIOCHEMISTRY ANALYSIS
  12. BLOOD COLLECTION FOR SAFETY ANALYSIS
  13. BIOLOGICAL MATERIAL COLLECTION FOR CENTRAL REPOSITORY
  14. DOUBLE-LABELED WATER (DLW) PROCEDURES
  15. CENTRAL BIOCHEMISTRY LABORATORY PROCEDURES
  16. DXA READING CENTER PROCEDURES
  17. NUTRITIONAL READING CENTER PROCEDURES
  18. ADHERENCE TO THE INTERVENTION
  19. QUALITY CONTROL ACTIVITIES
  20. EMERGING SCIENCES COMMITTEE PROCEDURES
  21. REGULATORY PROCEDURES
  22. SIGNS, SYMPTOMS AND ADVERSE EVENTS
  23. SERIOUS ADVERSE EVENTS
  24. SAFETY SURVEILLANCE PROTOCOLS
  25. DISCONTINUATION OF THE CR INTERVENTION
  26. PERIODIC SAFETY REPORT
  27. DATA MANAGEMENT PROCEDURES
  28. APPENDICES