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A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Cobiprostone for the Prevention of Severe Oral Mucositis in Subjects with Head and Neck Cancer (HNC) Receiving Concurrent Radiation and Chemotherapy (RT/CT)

Primary Outcome Measures 1.Proportion of subjects with a diagnosis of severe oral mucositis during the course of receiving up to 50 Gray (Gy) cumulative radiation dose administration with concurrent chemotherapy [ Time Frame: 50 Gray (Gy), up to 12 weeks ] 2.Overall mean Area Under the Curve (AUC) of oral mucositis severity over time [ Time Frame: 50 Gray (Gy), up to 12 weeks ] Secondary Outcome Measures  : 1.Time-to-onset of severe (World Health Organization [WHO] grade 3 or 4) oral mucositis following initiation of RT/CT [ Time Frame: 50 Gray (Gy), up to 12 weeks ] 2.Duration of severe (World Health Organization [WHO] grade 3 or 4) oral mucositis [ Time Frame: 50 Gray (Gy), up to 12 weeks ] 3.Weekly Quality of Life assessment (MD Anderson Symptom Inventory Head and Neck Cancer Module [MDASI-HN]) [ Time Frame: 50 Gray (Gy), up to 12 weeks ] 4.Mean cumulative radiation dose at time of severe (World Health Organization [WHO] grade 3 or 4) oral mucositis onset [ Time Frame: 50 Gray (Gy), up to 12 weeks ]

Primary Outcome Measures 1.Proportion of subjects with a diagnosis of severe oral mucositis during the course of receiving up to 50 Gray (Gy) cumulative radiation dose administration with concurrent chemotherapy [ Time Frame: 50 Gray (Gy), up to 12 weeks ] 2.Overall mean Area Under the Curve (AUC) of oral mucositis severity over time [ Time Frame: 50 Gray (Gy), up to 12 weeks ] Secondary Outcome Measures  : 1.Time-to-onset of severe (World Health Organization [WHO] grade 3 or 4) oral mucositis following initiation of RT/CT [ Time Frame: 50 Gray (Gy), up to 12 weeks ] 2.Duration of severe (World Health Organization [WHO] grade 3 or 4) oral mucositis [ Time Frame: 50 Gray (Gy), up to 12 weeks ] 3.Weekly Quality of Life assessment (MD Anderson Symptom Inventory Head and Neck Cancer Module [MDASI-HN]) [ Time Frame: 50 Gray (Gy), up to 12 weeks ] 4.Mean cumulative radiation dose at time of severe (World Health Organization [WHO] grade 3 or 4) oral mucositis onset [ Time Frame: 50 Gray (Gy), up to 12 weeks ]