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Study Protocol
Study Code: EVM18888Protocol version: 6.2
Date of last version: 08 January 2018ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITEDCONFIDENTIAL
When used outside AllerganSTUDY PROTOCOLStudy
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What is an open-label long-term safety?
An open-label long-term safety study is a type of clinical trial in which both the researchers and the participants know which treatment is being administered.
Who is required to file an open-label long-term safety?
Researchers and drug manufacturers are typically required to file an open-label long-term safety study to regulatory authorities.
How to fill out an open-label long-term safety?
To fill out an open-label long-term safety study, researchers must collect and report data on the safety and efficacy of the treatment over an extended period of time.
What is the purpose of an open-label long-term safety?
The purpose of an open-label long-term safety study is to monitor the long-term effects of a treatment and ensure that it is safe for use over an extended period of time.
What information must be reported on an open-label long-term safety?
Information that must be reported on an open-label long-term safety includes adverse events, changes in efficacy, and any other relevant data that may impact the safety of the treatment.
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