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A minimum mortality threshold was required because extremely low mortality rates may reflect inadequate testing furthermore, this limits the impact of floor effects in the analysis, explains the team

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Randomized trials based on hard clinical CV outcomes do, however, also have limitations, which have been considered in previous ESH/ESC Guidelines : (i) to limit the number of patients needed, trials commonly enrol high-risk patients (old age, concomitant or previous disease) and for practical reasons, the duration of controlled trials is necessarily short (in best cases between 3 and 6 years, with an average time to an endpoint of only half of this)so that recommendations for life-long intervention are based on considerable extrapolation from data obtained over periods much shorter than the life expectancy of most patients

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