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The trial product estimand evaluates the treatment effect for all randomised patients under the assumption that all patients remained on the trial product for the entire planned duration of the trial and did not use rescue medication

Warnings: Allergens : This product may contain milk (including lactose), soy, peanuts, other nuts, sesame seeds, gluten-containing grains, eggs, shellfish, and fish

10.1016/S0015-0282(02)02959-X

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The dose-escalation protocol used in TRIUMPH Phase 3 trials was specifically designed to improve this tolerability further

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