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| основное терапевтическое преимущество (согласно решению Совета ЕЭК № 78 Rada0414); значительное терапевтическое преимущество (In general, major therapeutic advantage would normally be based on meaningful improvement of efficacy (or clinical safety), such as having an impact on the onset and duration of the condition, or improving the morbidity or mortality of the disease. Rada0414) | |||