{"analyses":[{"ciLowerLimit":"-0.472","ciNumSides":"TWO_SIDED","ciPctValue":"95","ciUpperLimit":"0.991","dispersionType":"STANDARD_ERROR_OF_MEAN","dispersionValue":"0.373","estimateComment":"The treatment was considered efficacious if the group by time interaction for LVEF was statistically significant at a two-sided p\\<0.05 and the expected LVEF was higher for carvedilol than placebo over time.","groupDescription":"The null hypothesis is that change in LVEF across time do not vary by arm. Assuming a type I error=0.05, 2-sided test, 15% attrition/year, and correlation range of 1.2-1.6 between measurements, we projected that a sample size of 125/arm would provide 80% power to detect an effect size of 0.23-0.32 for LVEF at 24m.","groupIds":["OG000","OG001"],"nonInferiorityType":"OTHER","pValue":"0.49","paramType":"Slope","paramValue":"0.259","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":"0.69","value":"57.6"},{"groupId":"OG001","spread":"0.58","value":"57.42"}]}],"title":"BL"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.59","value":"58.16"},{"groupId":"OG001","spread":"0.6","value":"56.84"}]}],"title":"6m"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.62","value":"58.07"},{"groupId":"OG001","spread":"0.7","value":"56.61"}]}],"title":"12m"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.69","value":"57.35"},{"groupId":"OG001","spread":"0.71","value":"57.6"}]}],"title":"18m"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.79","value":"58.16"},{"groupId":"OG001","spread":"0.62","value":"57.5"}]}],"title":"24"}],"denoms":[{"counts":[{"groupId":"OG000","value":"75"},{"groupId":"OG001","value":"76"}],"units":"Participants"}],"description":"The percentage of blood leaving the heart at the end of diastole. 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 Ejection Fraction","type":"SECONDARY","unitOfMeasure":"Percent"}