def controlled - Placebo N=~200 See Soligenix Ph3 --- DOM-INNATE and again, note Incidence Prevention of SOM is Secondary, sole Primary measure is Duration of SOM
Primary Outcome Measures:
Duration of severe oral mucositis (SOM) [ Time Frame: approx. 13 weeks ] To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis (SOM; defined as World Health Organization [WHO] Grade ≥3). Duration of SOM is defined as the number of days from the onset of SOM until resolution of SOM. OM is evaluated using the published WHO OM grading scale that uses a scale of 0 to 4, with SOM defined as a score ≥3.