The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy

Inclusion Criteria:

- Males or females, aged between 50 and 75.

- Outpatients scheduled for screening or surveillance colonoscopy for polyps or
colorectal cancer )

- Able to comprehend the full nature and purpose of the study, including possible risks
and side effects.

- Able to co-operate with the investigator and to comply with the requirements of the
entire study.

- Signed written informed consent prior to inclusion in the study.

Exclusion Criteria:

- Patients at high risk of colorectal cancer e.g. ulcerative colitis

- Previous medical history of, or suspected hypersensitivity to, the Methylene Blue
and/or formulations' ingredients.

- Previous medical history of, or suspected hypersensitivity to, the PEG based bowel
cleansing preparation and/or bowel cleansing formulations' ingredients.

- Previous medical history of gastrointestinal obstruction or perforation, toxic
megacolon, major colonic resection, severe diverticulitis, heart failure (Class III or
IV), serious cardiovascular disease, ulcerative colitis or Crohn's disease.