{"analyses":[{"ciNumSides":"TWO_SIDED","ciPctValue":"95","groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY","pValue":">0.99","paramType":"Odds Ratio (OR)","paramValue":"1.11","statisticalMethod":"Fisher Exact"}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"8"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"83"},{"groupId":"OG001","value":"81"}],"units":"Participants"}],"description":"Data analysis will be performed on an intention-to-treat basis. Logistic regression will be used to estimate the odds ratio and 95% confidence interval of the two treatment groups with the adjustment of baseline covariates. Outcome comparisons for categorical/dichotomous variables will be assessed by 2 test or Fisher's exact test where expected cell frequencies were \\<5; continuous variables will be compared by X/2 test or by Mann-Whitney U test where the data are strongly skewed.","groups":[{"description":"Patients receive cyclosporine ophthalmic emulsion (Restasis®) drops in each eye twice daily for up to 1 year after transplant.\n\ncyclosporine ophthalmic emulsion: Given as eye drops","id":"OG000","title":"Arm I"},{"description":"Patients receive placebo ophthalmic drops in each eye twice daily for up to 1 year after transplant.\n\nplacebo: Given as eye drops","id":"OG001","title":"Arm II"}],"paramType":"NUMBER","populationDescription":"Number of patients that develop ocular GVHD while on study","reportingStatus":"POSTED","timeFrame":"Up to 2 years after transplantation","title":"Number of Patients That Develop Ocular GVHD While on Study in the Two Arms (Ocular Cyclosporine (Restasis) vs. Placebo)","type":"PRIMARY","unitOfMeasure":"participants"}