An open-label extension (OLE) study is a type of clinical trial that follows a previous, often blinded, study. In an OLE, participants who were in the original study (e.g., a double-blind randomized controlled trial) are offered the opportunity to continue taking the study drug openly, meaning both the participants and the investigators know which treatment they are receiving. The primary purpose of an OLE is to gather long-term safety and tolerability data about the drug, often after the initial trial is complete and the drug is awaiting or has received regulatory approval.
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