Layperson Summary/Plain Language Summary (PLS)

To increase transparency of the pharmaceutical sector, the Regulatory Authorities now require the provision of information aimed directly at the lay audience. Therefore, a Plain Language Summary (PLS) should now accompany the summary of clinical study results according to the EU clinical trial regulation 536/2014. A PLS should contain a description of the design and aggregate results of individual clinical studies in plain language. The goal of such summaries is to aid study participants and the general public in understanding clinical study results.

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