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Dividing the dose 40 mg over the course of the day is not recommended. Keep out of reach of children. Revised: May Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Tadalafil was administered to patients with PAH during clinical trials worldwide. In the placebo-controlled study, the most common AEs were generally transient and mild to moderate in intensity. These events have been chosen for inclusion either because of their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors.
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