Period 1 - unblinded treatment for up to 240 weeks for patients who enroll from Study H9B-MC-BCDO (BCDO) (NCT01202760) or Study H9B-MC-BCDV (BCDV) (NCT01202773) or up to 168 weeks for patients who enroll from Study H9B-MC-BCDM (BCDM) (NCT01198002).