Extension Study for 2993-112

Inclusion Criteria

• •All of the following criteria are to be fulfilled for inclusion of an individual in the study unless the sponsor grants an exception:
• •Has completed the 30-week triple-blind treatment initiation/active treatment periods in Protocol 2993-112, including all procedures required at the study termination visit (Week 30).
• •Male or female. Female individuals must be either 1) postmenopausal as documented by serum FSH measurement unless using estrogen for hormone replacement therapy; or 2) of childbearing potential and used appropriate contraceptive methods (surgical sterility or oral, injected, barrier, intrauterine, or implanted contraceptives) for the duration of Protocol 2993-112. This individual must have a current, negative pregnancy test (human chorionic gonadotropin \[HCG\], beta subunit) regardless of birth control method used. The individual agrees to continue using birth control throughout the study to prevent pregnancy.
• •Able to understand and sign a Protocol 2993-112E-specific informed consent form, communicate with the investigator, and understand and comply with the protocol requirements.
• •Individuals meeting any of the following criteria are to be excluded from the study unless the sponsor grants an exception:
• •Has not completed Protocol 2993-112.
• •Female individuals who are pregnant, lactating, or planning to become pregnant.