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PurposeA diazepam auto‐injector (AI) has been developed for intramuscular administration to treat acute repetitive seizures (ARS). The objective of this study was to evaluate the efficacy and safety of the diazepam AI when administered by caregivers to control an episode of ARS.
MethodsIn this phase III, randomized, double‐blind, parallel‐group, placebo‐controlled, multicenter study, subjects with...
ObjectivesTo compare the pharmacodynamic effects, including self‐reports of “drug liking” and “high,” of crushed morphine sulfate and naltrexone hydrochloride extended‐release capsules (MSN), crushed morphine sulfate controlled‐release (CR) tablets, and placebo in an abuse potential study.
DesignRandomized, double‐blind, placebo‐controlled, three‐way crossover study.
SettingSingle‐center.
SubjectsNondependent...
A number of pharmacologic treatments examined in recent randomized clinical trials (RCTs) have failed to show statistically significant superiority to placebo in conditions in which their efficacy had previously been demonstrated. Assuming the validity of previous evidence of efficacy and the comparability of the patients and outcome measures in these studies, such results may be a consequence of...
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