The primary safety
end point was a composite of major adverse
events, defined as death from any cause, endstage
renal disease, an embolic event resulting in
end-organ damage, renal-artery or other vascular
complications, or hypertensive crisis within 30
days or new renal-artery stenosis of more than
70% within 6 months. The objective performance
criterion for the primary safety end point was a
rate of major adverse events of 9.8%, which was
derived from historical data.
The primary safetyend point was a composite of major adverseevents, defined as death from any cause, endstagerenal disease, an embolic event resulting inend-organ damage, renal-artery or other vascularcomplications, or hypertensive crisis within 30days or new renal-artery stenosis of more than70% within 6 months. The objective performancecriterion for the primary safety end point was arate of major adverse events of 9.8%, which wasderived from historical data.
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