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Secondary efficacy and safety end points were also measured.
No significant treatment effect was noted in the occurrence of the safety end point.
Rate of missed acute coronary syndrome within 28 days was the safety end point.
The primary safety end point was the rate of serious adverse events related to the procedure.
The two primary safety end points are acute and chronic SonR lead-related complication rates, respectively.
The primary safety end point is the incidence of major bleeding.
Additional efficacy and safety end points will be captured at 1 and 3 years.
Safety end points were Grade 3/4 toxicities, serious adverse events, withdrawals because of toxicity, and deaths due to toxicity.
Safety end points were analyzed descriptively.
Abandon treatment platform: harm (in efficacy or safety end points).
Safety end point analysis is required to address drug risk.
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