What will happen in the study?

This study will last up to 108 weeks (about 2 years). It will require 17 visits to the clinic site.

Here are some of the things that will happen in this study:

You will:

• Be asked to perform screening tests and procedures to figure out if you qualify for the study. You will visit the clinic site 2 times (visit 1-2). You will not receive any treatment.

• Receive either the study drug or placebo every day for 48 weeks. You will visit the clinic site 9 times.

• If you complete the first 48 week, you may choose to receive study drug every day for another 48 weeks. You will visit the clinic site 4 times and have one phone call with the study team.

• A safety follow-up visit will occur 4 weeks later to ensure there has not been development of any late side effects.