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However, avoid contact with the eyes

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(2) Dose adjustment: Start elderly patients on a low dose and gradually adjust according to their tolerance and response, avoiding high doses

While safety within the phase 3 program is sufficient for marketing authorization (although the risk of cardiovascular events should not exceed a hazard ratio of 1.8 according to a guidance document that was released by the FDA at that time), it is the post-marketing phase in which rare adverse events and any other potential safety risks are identified or resolved

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