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Analysis
Pre-specified analysis plan
Analysis by intention to treat
Avoids bias due to non random exclusion Less likely to overestimate a positive result
Multiple analysis and subgroup testing
Hypothesis generating and pre specified
Only pre-specified interim analysis
Reporting trials
• Compliance with statistical analysis plan
• Consort statement
• Highlighting strengths and weaknesses
• What do the results mean?
• Rational interpretation of data
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