Among subjects 35 years or less, there were 23 pregnancies (4 of these occurred during the interval 1 to 14 days after the last day of pill use) during 12,572 28-day pill packs of use. The efficacy of Amethyst™ was assessed by the number of pregnancies that occurred after the onset of treatment and within 14 days of the last dose. The mean weight of subjects in this study was 70.38 kg. Of these subjects 1,213 (56.8%) discontinued prematurely, including 102 (4.8%) discontinued by the Sponsor for early study closure. The primary efficacy and safety study (313-NA) was a one-year open-label clinical trial that treated 2,134 subjects in North America. There were no exclusions for body mass index (BMI), weight, or bleeding history. The efficacy and safety of Amethyst™ were studied in 2 one-year clinical trials of subjects age 18 to 49.
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