P-valueA p-value, which stands for probability value, is a statistical measure between 0 and 1. It is used for hypothesis testing. In clinical trials it is used to give an indication of whether a result observed may be due to chance, or not.A significance level should be set before data collection(...)
Package InsertThe Package Insert (formerly prescribing information) in the United States (USPI), is a document included inside the external packaging of a prescription or over-the-counter medicine to provide information for patients. In Europe, the patient information in the pack is the Package Leaflet (PL)(...)
Package Leaflet (PL)A folded leaflet that comes inside the package with the medicine.
Package LeafletIn the EU, medicinal products must be accompanied by outer and/or immediate packaging information (labelling) and a Package Leaflet (PL). The PL should be written in language understandable by the patient and must undergo readability testing. It contains:
What medicine X is and what it is(...)
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