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Finally, due to the small number of events occurring across studies, the results for severe gastrointestinal AEs and discontinuation outcomes were particularly sensitive to small differences in events and allow for broad comparisons only
Interestingly, nonfatal heart attack showed the largest risk reduction among the three primary outcome components, contrasting with the earlier PIONEER 6 trial where cardiovascular death was the dominant benefitlikely because SOUL's longer follow-up and larger sample size (approximately three times that of PIONEER 6) allowed more comprehensive assessment of cardiovascular outcomes
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