{"anticipatedPostingDate":"2027-10","denomUnitsSelected":"Participants","description":"An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to that medicinal product. AEs included clinically significant vital signs measurements, clinical laboratory values and electrocardiograms (ECGs) changes.","reportingStatus":"NOT_POSTED","timeFrame":"Up to approximately 3 years in the extension phase","title":"Extension Phase: Number of Participants With AEs","type":"OTHER_PRE_SPECIFIED"}