{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.1760","value":"0.0314"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"115"}],"units":"Participants"}],"title":"Day 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.2473","value":"0.0528"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"110"}],"units":"Participants"}],"title":"Month 1"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.1956","value":"0.0998"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"}],"units":"Participants"}],"title":"Month 3"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.1798","value":"0.0974"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"76"}],"units":"Participants"}],"title":"Month 6"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.2334","value":"0.1067"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"59"}],"units":"Participants"}],"title":"Month 9"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.2287","value":"0.1097"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"55"}],"units":"Participants"}],"title":"Month 12"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.2027","value":"0.1101"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"}],"units":"Participants"}],"title":"Month 18"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.1604","value":"0.0383"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"14"}],"units":"Participants"}],"title":"Month 24"}],"denoms":[{"counts":[{"groupId":"OG000","value":"126"}],"units":"Participants"}],"description":"The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. The EQ-5D-5L health utility index (HUI) is assessed using the Crosswalk algorithm for France based on the individual responses to the 5 EQ-5D-5L domains ranging from -0.530 to 1.000. The smallest change considered clinically meaningful, is defined as a score difference of 0.08 points.","dispersionType":"Standard Deviation","groups":[{"description":"BB2121","id":"OG000","title":"BB2121"}],"paramType":"MEAN","populationDescription":"PRO Analysis Set","reportingStatus":"POSTED","timeFrame":"At Day 1 and at specific time points up to month 24","title":"Mean Change From Baseline on the EQ-5D-5L Index","type":"SECONDARY","unitOfMeasure":"Score on a Scale"}