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When taken weekly to prevent malaria, amodiaquine was associated with agranulocytosis and hepatitis [8], [9]; large scale safety data on AQ as a malaria treatment is lacking, but its safety is considered to be acceptable [10].
This makes the databases ideally suited to large scale safety studies of commonly used drugs.
Although cardiovascular events do not appear to be increased with intravitreal anti-vascular endothelial growth factor drugs, large scale safety studies are still needed.
A number of studies have not demonstrated significant efficacy, and there is a need for large scale safety studies to ensure that thromboembolic events do not become a major cause of morbidity.
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They usually are conducted concurrently with Phase 3 (large-scale safety and efficacy) clinical trials but may begin earlier if there is reason to suspect that the drug is a carcinogen.
So Molyneux worked with an international team of researchers and the government of Zanzibar to launch the first large-scale safety study of all three drugs.
The design information of the material layout may be helpful in dealing with large-scale safety design issues in civil or architectural engineering fields, against natural phenomena, such as winds and earthquakes.
As a result, large phase III trials may not be needed, although a large-scale safety study may be needed post-licensure because tolerated risk may drop significantly after a few years.
Despite this concern, no independent, large-scale safety assessment has been undertaken.
REST evaluated the large-scale safety of RV5, primarily with respect to intussusception.
To date, most large-scale safety assessments of adalimumab are based on trials of patients with RA.
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