1. DISCUSSION: Discuss the effectiveness of AG200-15, including: (a) Interpretation of efficacy results from Study 23 as they relate to study design and enrolled patient population; and (b) Interpretation of subgroup analyses by body mass index, weight, and race/ethnicity.

2. DISCUSSION: Discuss the safety profile of AG200-15, including: (a) Interpretation of the venous thromboembolism (VTE) safety signal as it relates to weight and body mass index (BMI); and (b) Interpretation of the product tolerability (e.g., cycle control).

3. VOTE: Do the benefits of AG200-15 outweigh its risks to support the drug’s approval for the prevention of pregnancy?

If you vote YES, explain the rationale for your vote and address the following: (a) Whether this product should be approved for use in the general population or a more narrowly defined patient population; and (b) How this product should be used within the context of available contraceptive therapies.

If you vote NO, explain the rationale for your vote and provide any recommendations.

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