Calerie Centers
Manual of Procedures for the Phase 2 Study
- SUMMARY OF THE PHASE 2 PROTOCOLS
- SPECIFIC AIMS AND OBJECTIVES/HYPOTHESES
- SOURCES OF DATA
- RECRUITMENT PROCEDURES
- SCREENING PROCEDURES
- BASELINE ACTIVITIES
- RANDOMIZATION AND BLINDING
- FOLLOW-UP EVALUATIONS
- EVALUATION PROTOCOLS
- DLW PROCEDURES AT THE SITES
- BLOOD COLLECTION FOR CENTRAL BIOCHEMISTRY ANALYSIS
- BLOOD COLLECTION FOR SAFETY ANALYSIS
- BIOLOGICAL MATERIAL COLLECTION FOR CENTRAL REPOSITORY
- DOUBLE-LABELED WATER (DLW) PROCEDURES
- CENTRAL BIOCHEMISTRY LABORATORY PROCEDURES
- DXA READING CENTER PROCEDURES
- NUTRITIONAL READING CENTER PROCEDURES
- ADHERENCE TO THE INTERVENTION
- QUALITY CONTROL ACTIVITIES
- EMERGING SCIENCES COMMITTEE PROCEDURES
- REGULATORY PROCEDURES
- SIGNS, SYMPTOMS AND ADVERSE EVENTS
- SERIOUS ADVERSE EVENTS
- SAFETY SURVEILLANCE PROTOCOLS
- DISCONTINUATION OF THE CR INTERVENTION
- PERIODIC SAFETY REPORT
- DATA MANAGEMENT PROCEDURES
- APPENDICES