Participants will be chosen at random to receive either the investigational medicine or the placebo, which looks just like the investigational medicine but does not contain active ingredients. Both the investigational medicine and the placebo are tablets taken orally twice daily.
Participants will be asked to attend 12 visits to the study site. The total length of participation is approximately 62 weeks and consists of:
- Screening – The screening period can last up to six weeks and will evaluate interested individuals to make sure the study is a good match for them.
- Study treatment – The study treatment period lasts 52 weeks and is double-blind, which means neither the participant nor the study doctor will know whether the participant is receiving the investigational medicine or the placebo. During this period, the participant will take the assigned study treatment and attend regular visits at the study site, where doctors and nurses will check on their health. Participants who complete the 52-week treatment period may be eligible to enter a 52-week open-label extension study. “Open-label” means that the participant will receive the investigational medicine, and everyone will be aware that they are taking the investigational medicine and not the placebo.
- Safety follow-up – The safety follow-up visit occurs four weeks after the last dose of the investigational medicine for participants who choose not to enter the open-label extension study. The purpose of this visit is to check on participants’ health after stopping the investigational medicine.
Throughout the study, the study doctor may perform a number of tests and procedures, including but not limited to:
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- Recording medical history
- Conducting a physical exam
- Measuring vital signs
- Performing electrocardiograms
- Collecting blood and urine samples