{"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":"<0.005","statisticalMethod":"Linear Repeated Measures Model","testedNonInferiority":false}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","lowerLimit":"-34.8","upperLimit":"20.9","value":"4.9"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"39"}],"units":"Participants"}],"description":"The change in methylation will be analyzed in parallel using a linear repeated measures model. The fixed effects will be time (pre-treatment versus post-treatment), current smoking status (yes or no), their interaction, and tissue type (tumor or not). Satterthwaite's adjustment to the degrees of freedom will be applied to account for heteroscedasticity. The differential effect of soy isoflavone on tumor and non-tumor tissues between smokers and non-smokers will be assessed using linear contrasts.","dispersionType":"Full Range","groups":[{"description":"Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.","id":"OG000","title":"Treatment (Soy Isoflavones)"}],"paramType":"MEAN","populationDescription":"55 patients were enrolled. 3 patients did not undergo treatment. 13 patients had insufficient tissue and were therefore not evaluable. Only the 39 evaluable patients were included in the analysis.","reportingStatus":"POSTED","timeFrame":"From baseline to surgery, up to 42 days","title":"Mean Percent Change in p16 Methylation (% CpG Sites Methylated) in Tumor Tissue After Soy Isoflavone","type":"PRIMARY","unitOfMeasure":"Percent change"}