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Phase IV studies
For new drugs or vaccines, the evidence from one or more Phase III trials, taken together with the results of the Phase
I and II trials, will be presented to licensing authorities to register the product for clinical or public health use.
However, the total number of participants included in Phase I to III trials of a new product will often be no more than
a few thousand, and there are usually important public health issues that will have been incompletely addressed at the
time a product is licensed.
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