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Index
Cover
Frontmatter
1. Introduction to Clinical Trials
2. Ethical Issues
3. What Is the Question?
4. Study Population
5. Basic Study Design
6. The Randomization Process
7. Blinding
8. Sample Size
9. Baseline Assessment
10. Recruitment of Study Participants
11. Data Collection and Quality Control
12. Assessment and Reporting of Harm
13. Assessment of Health Related Quality of Life
14. Participant Adherence
15. Survival Analysis
16. Monitoring Committee Structure and Function
17. Statistical Methods Used in Interim Monitoring
18. Issues in Data Analysis
19. Closeout
20. Reporting and Interpreting of Results
21. Multicenter Trials
22. Regulatory Issues
Erratum
Backmatter
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