Clinical Research Directory

Inclusion Criteria: * Patients are able to provide written informed consent to enter the extension part. * Patients must be on study treatment at the time of EoT visit in the core part. Exclusion Criteria: * Patients meeting any exclusion criteria in the core part. * Patients who have a history or evidence of any clinically significant disorder, condition, or disease that in the investigator's opinion or Sponsor physician (if consulted), would put the participant at risk or interfere with the study participation * History of hypersensitivity to the study drug or its excipients, to drugs of similar chemical classes * Any medical or psychiatric condition which in the judgment of the Investigator either requires urgent medical intervention/hospitalization or may preclude patients from complying with study requirements for the duration of the study. Other protocol defined Inclusion/Exclusion criteria may apply