{"analyses":[{"ciLowerLimit":"-5.595","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"8.091","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"3.491","estimateComment":"The treatment can be considered beneficial if the mean difference (treatment - control) slope is negative.","groupDescription":"The null hypothesis is that change in Average Alanine aminotransferase across time-points described above does not differ by treatment arm, tested using a longitudinal GEE analysis of Average Alanine aminotransferase with a treatment by time interaction.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.72","paramType":"Slope","paramValue":"1.248","statisticalComment":"The treatment effect was determined by testing the significance of the group by time interaction in GEE using a one degree-of-freedom (df) test.","statisticalMethod":"Generalized Estimating Equation (GEE)"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.31","value":"29.122"},{"groupId":"OG001","spread":"1.948","value":"30.467"}]}],"title":"BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.533","value":"28.014"},{"groupId":"OG001","spread":"2.516","value":"32.158"}]}],"title":"6m"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.985","value":"30.148"},{"groupId":"OG001","spread":"2.742","value":"31.155"}]}],"title":"12m"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"2.645","value":"27.196"},{"groupId":"OG001","spread":"3.567","value":"30.536"}]}],"title":"18m"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"3.064","value":"29.86"},{"groupId":"OG001","spread":"2.626","value":"29.245"}]}],"title":"24m"}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"76"}],"units":"Participants"}],"description":"A liver function measurement (in U/L). Normal range is 8-48 IU/L. The mean is reported by arm at each timepoint with corresponding standard errors.","dispersionType":"Standard Error","groups":[{"description":"Patients received Carvedilol PO delivered at 6.25 mg twice daily (for a total dose of 12.5 mg per day) for 24 months.","id":"OG000","title":"Arm I (Carvedilol)"},{"description":"Patients received Placebo PO delivered at 6.25 mg twice daily (for a total dose of 12.5 mg per day) for 24 months.","id":"OG001","title":"Arm II (Placebo)"}],"paramType":"MEAN","populationDescription":"We excluded 31 participants who did not have a second time point assessment of echocardiography, resulting in 151 analyzable participants.","reportingStatus":"POSTED","timeFrame":"Baseline before treatment, 6 months, 12 months, 18 months, 24 months after treatment initiation","title":"Average Alanine Aminotransferase","type":"SECONDARY","unitOfMeasure":"IU/L"}