After granting permission to be contacted, a study representative will call you. During this initial phone call, the study representative will ask additional screening questions and may confirm the answers you have submitted online.

The next step will be to set up an in-person visit to a local study site to enroll in the research study.  Study sites are medical facilities where study-related activities will occur. At this visit, you will receive additional information about the trial. You may be required to complete further screening at the study site to confirm your eligibility.

Informed Consent - Before enrolling in the study, participants will read and sign an informed consent document that gives a full explanation of all activities that will happen during the study. A participant can withdraw their consent from the study at any time.

Once you have enrolled, you may receive the study drug or a placebo in the first treatment period. 2 out of 3 (66%) participants will receive the investigational study drug, while 1 out of 3 (33%) will receive a placebo. During the second treatment period, all participants (100%) will receive the study drug.

Participation will last about 18 months (from screening visit to last visit of the mandatory follow up period). During the study, you will be asked to come to the study site approximately 17 times, which is about once every four weeks, and for some visits once every eight weeks.