['oral mucositis']
['cobiprostone', 'placebo', 'standard care - chemotherapy']

        Inclusion Criteria:

          -  Recently-diagnosed (within the last 6 months), histologically-documented,
             non-metastatic squamous cell carcinoma of the oral cavity and/or oropharynx amenable
             to radiotherapy with concurrent chemotherapy as the definitive treatment modality.

          -  Clinical treatment plan calls for a minimum of 50 Gy cumulative radiation dose
             administered via continuous course of external beam irradiation to the oral cavity
             and/or oropharynx via intensity-modulated radiation therapy (IMRT) and/or image-guided
             radiation therapy (IGRT), combined with conventional or weekly/tri-weekly cisplatin or
             carboplatin chemotherapy regimen.

        Exclusion Criteria:

          -  Subject has received prior radiation to the head and neck region (+/- chemotherapy).

          -  Subject has had any other prior invasive malignancy, unless disease-free for a minimum
             of 3 years.

          -  Subject has metastatic disease (M1) Stage IV-C.

          -  Subject has a presence of mucosal ulceration or oral mucositis at screening or
             develops this prior to randomization, and/or has unhealed wounds remaining from
             surgical resection and/or excisional biopsy procedure.

          -  Subject is using a pre-existing feeding tube for nutritional support at study entry.
      