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This is a Phase 1, multi-center, open-label study designed to evaluate the safety and pharmacokinetics of EXPAREL when administered via local wound infiltration to subjects undergoing open cervical or thoracic spinal fusion or reconstructive surgery.
Fifteen subjects are planned for enrollment.
This is a Phase 4, multicenter, randomized, double-blind, controlled study in approximately 220 adult subjects undergoing primary, 1-2 level, open lumbar spinal fusion surgery under general anesthesia.
Subjects will be screened within 30 days prior to study drug administration and at least one day
Background Some maternal blood loss normally occurs at the time of vaginal delivery. The best estimates indicate that a loss of approximately 500 mL is average, with a range of about 250-700 mL.[1,2] Some of this bleeding arises from birth canal lacerations or surgical incisions (i.e., episiotomy),
1.0 Background
While atrial fibrillation (AF) is the most common sustained cardiac arrhythmia requiring therapy, it is also associated with increased risk of stroke, heart failure, myocardial infarction, dementia, and death. The number of Americans affected with AF is expected to surge to nearly 16
Intracranial arteriovenous malformations (AVMs) are relatively uncommon but increasingly discovered lesions that can lead to significant neurological disability or death.1 Population-based data suggest that the annual incidence of discovery of a symptomatic AVM is approximately 1.1 per 100 000
Background In 2007 Colombia was one of the five countries in the world with the highest number of anti-personnel landmine victims [1]. These are small devices designed to injure or kill people and animals by exploding when a minimum pressure is exerted on them (approximately 6 Force-Kg) [2]. Between