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Key Issues in Analysis

Approaches. Treatment received" (also referred to as per protocol" or as treated")Analyze only fully eligible and compliant subjects with no missing data, e.g., valid" and evaluable" subjectsIntention to treat" (also referred to as full analysis" set and as randomized")Analyze all ran

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Key Issues in Analysis

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    1. Key Issues in Analysis Who gets analyzed? How are they grouped for analysis?

    2. Approaches “Treatment received” (also referred to as “per protocol” or “as treated”) Analyze only fully eligible and compliant subjects with no missing data, e.g., “valid” and “evaluable” subjects “Intention to treat” (also referred to as “full analysis” set and “as randomized”) Analyze all randomized subjects utilizing as much information from each as possible

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