Reported serious1 adverse events.

1Serious definition according to ICH/Good Clinical Practice as any untoward and unintended response that results in death, is immediately life-threatening, requires in-subject hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital abnormality or birth defect or is an important medical event that may jeopardize the patient or may require medical intervention to prevent one of the outcomes listed above.