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To allow close safety monitoring, all patients were hospitalized during the first treatment cycle or until the investigator considered it appropriate to manage the patient on an outpatient basis.
During the treatment period, subjects were hospitalized in the PAREXEL Early Phase Clinical Unit (Berlin, Germany) from 1 day before the study drug administration until 3 days after administration for serial PK sampling and close safety monitoring.
In view of the possibility of a monacolin interaction with antiviral agents through a cytochrome P450 mechanism, such a study with close safety monitoring may be warranted in the search for additional lipid-lowering agents compatible with HIV therapies.
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Closing safety holes requires that "the safety inspector/auditor of research laboratories directly report to an identified individual/office with organizational authority to implement safety improvements," the report concludes.
20 There is a recognised need for instruments or tools that can be used by regulatory agencies to identify individuals who may be at higher risk of having brain injury from cumulative head trauma and require closer safety surveillance.
Dawn on June 15 found them at the Chickahominy River, close to safety but rendered impassable by spring rains.
The incident happened when the men were agonisingly close to safety as they travelled the final few miles to the Turkish border.
So many persons get into difficulty close to safety that the rescuer may often act without entering the water at all.
"Who would have thought Leicester would be this close to safety after four and a half months in the bottom three?
Under intense heat waves, nuclear plants may even need to close for safety reasons, this happened in France, Germany and Spain in 2006, and later in Sweden.
Close the safety gap: Provide government with the legal tools necessary to identify, prioritize, and take action to reduce chemical hazards and exposures.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com