ITT Population: The ITT (Intent-to-Treat) population includes all subjects who are randomized in the study, regardless of whether they received the treatment or adhered to the study protocol. For example, if a study randomizes 20 subjects, with 15 receiving the treatment, 3 not receiving the treatment, and 2 not assigned treatment, then: RANDFL: This includes all subjects who were randomized, so RANDFL="Y" for all 20 subjects. ITTFL: This includes all randomized subjects, whether or not they received the treatment. Therefore, ITTFL="Y" for the 18 subjects who were either treated or not treated (excluding the 2 not assigned treatment). SAFFL: This includes only those subjects who received at least one dose of the treatment. Therefore, SAFFL="Y" for the 15 subjects who were treated. I hope this clarifies the definitions and examples for you. Thanks, VV
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