{"denomUnitsSelected":"Participants","description":"Changes in parameters will be both graphically and quantitatively summarized and explored. Standard paired comparisons methodologies (paired t-tests, Wilcoxon signed rank tests and Fisher's exact tests for interval, ordinal and nominal level data, respectively) will be used to assess changes in these variables before and after therapy. In addition, these changes in pharmacologic markers and biological results will be explored in relation to clinical outcome to explore any differences between responders and non-responders.","reportingStatus":"NOT_POSTED","timeFrame":"Baseline to up to 12 courses","title":"Changes in Biological Markers","type":"OTHER_PRE_SPECIFIED"}