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4.2 Subject Selection 4. 4.3 Data Sources 4. 4.4 Variable Abstraction 4. 5. Statistical Plan 4. 5.1 Primary and Secondary Endpoints 4. 5.2 Statistical Methods 4. 5.3 Sample Size and Power 5. 6. Study Administration 5. 6.1 Data Collection and Management 5. 6.1.2Records Retention 6. 6.2 Regulatory and Ethical Considerations 6. 6.2.1 Risk ... ................
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