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When BioSante announced that efficacy studies didn't meet the end points they stated their intention to go forward with the safety part of the study, which completed enrollment of 3,656 women. The safety study is designed for a total of five years; however, BioSante could use the safety study data as part of a New Drug Application (NDA) submission after the last subject enrolled has completed 12 months of exposure to LibiGel or placebo. Confirming their intentions, BioSante continued the safety study until September 2012.

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