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Efficacy analyses were performed on two sets: the full analysis set, defined as all unique randomized patients grouped according to the treatment assigned at randomization, thereby following the intent-to-treat principle, and an on-treatment analysis, defined as all exposed patients while they were receiving treatment (that is, had received at least one dose in the previous 35 d), grouped according to the treatment that they received

The 7.5mg and 12.5mg intermediate doses were included in clinical protocols as transitional steps to improve tolerability but were not separate study arms in SURMOUNT-1

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