If you are eligible and agree to participate in this study, you will either receive the study drug or placebo during the treatment period. A placebo is a substance that looks like and is taken the same way as the real drug, but has no active ingredients.
In clinical trials, a placebo is given to some participants so that the two groups—for BALANCE, it’s those taking the investigational drug vs. those taking the placebo—can be compared to show whether the drug being studied is safe and is effective. A placebo can also help researchers determine whether certain changes during the study happen by chance or actually in response to the investigational drug.
At the end of this study you may have the option to participate in an open label extension study where every participant will receive the investigational drug.