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For some countries, the transition period for warning implementation on packages has not been completed as of early 2012 when this paper was written

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Comparison to Reference product: Applicant to demonstrate the product meets a defined standard or deviates from a standard with justification

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Patients were randomized to receive lorazepam 2 mg IV (with an additional 2 mg IV if needed) or diazepam 5 mg IV (with an additional 5 mg IV if needed)