This is a multicenter, 6 months open label safety extension study for all patients who are willing and eligible to continue from the pivotal, double-blind S308.3.001 trial

Inclusion Criteria:

• Patients who have completed S308.3.001 trial

Exclusion Criteria:

• Patients with medically relevant abnormal findings (ECG, physical examination, AEs) at end of the maintenance phase (visit M6, week 24) of study S308.3.001