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 (oestrogen 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
Male patients:
Must agree to use a latex condom during sexual contact with women of childbearing potential while participating in the study for at least 75 days after treatment discontinuation.
All patients:
Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea method (LAM) are not acceptable methods of contraception. Female condom and male condom should not be used together.