For people ages 18-55
Eligibility Criteria:
To be eligible to participate in this trial, patients must meet all of the following criteria:
- Completed one of the parent trials
- Does not have a condition that would require withdrawal from one of the parent trials
- Has no conditions requiring treatment with a prohibited concomitant medication
- Is not receiving treatment with any of the following drugs or interventions within the corresponding timeframe:
At Baseline (Day 1)
- CYP2C8 inhibitors (eg, gemfibrozil or clopidogrel) or inducers (eg, rifampicin) Two weeks prior to Baseline (Day 1)
- Monoamine oxidase inhibitors (eg, selegiline, phenelzine)
- Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
- Female patients of childbearing potential:
Must agree to practice a highly effective method of contraception throughout the study until completion of the 90-day Safety Follow-up Visit. Highly effective methods of contraception are those that alone or in combination result in a failure rate of a Pearl index of less than 1% per year when used consistently and correctly.
Acceptable methods of birth control in this study are the following:
- Combined hormonal (estrogen and progestogen containing) contraception, which may be oral, intravaginal, or transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injectable, or implantable
- Placement of an intrauterine device (IUD)
- Placement of an intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Vasectomised partner
- Sexual abstinence.
Exclusion Criteria: