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SUMMARY OF CHANGES
INCLUDED IN THE FULL PROTOCOL AMENDMENT OF:HP TN 083
A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to
Daily Oral Tenofovir Bisoprolol
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What is safety and efficacy of?
Safety and efficacy refer to the measures of how well a product works and how safe it is for use.
Who is required to file safety and efficacy of?
The manufacturer or sponsor of a product is required to file safety and efficacy data.
How to fill out safety and efficacy of?
Safety and efficacy data can be filled out by conducting clinical trials and submitting the results to regulatory authorities.
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The purpose of safety and efficacy data is to ensure that products are safe and effective for consumers.
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Information on clinical trials, adverse reactions, and effectiveness of the product must be reported.
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