Here’s a concise and helpful reply you could post: You’re right — the definitions can vary depending on the study design. Generally, the ITT (Intent-to-Treat) population includes all participants randomized, regardless of whether they completed the study or adhered to treatment. The safety population, on the other hand, typically includes those who actually received at least one dose and have safety data available (like vitals or labs). So yes, the ITT set can sometimes be larger or smaller depending on how the study defines these groups or if certain analyses are limited to specific subgroups. Always best to check the statistical analysis plan (SAP) for the exact definitions used.
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