Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)

Inclusion Criteria:

• Male or female age 18 to 75 years of age (inclusive) at the time of screening.
• Females of childbearing potential, defined as a female who is fertile followingmenarche, must have a negative serum pregnancy test at screening and agree to use anacceptable method of contraception throughout their participation in the study. Note: Female subjects who have been surgically sterilized (e.g., hysterectomy or bilateraltubal ligation) or who are postmenopausal (defined as total cessation of menses for > 1year) will not be considered "female subjects of childbearing potential".
• Subject is hospitalized with liver cirrhosis and/or OHE and has a confirmed diagnosisof OHE at Baseline.
• Subject has a Grade 2 or Grade 3 HE episode according to the HE Grading Instrument (HEGI) following 8 to 12 hours of intravenous (IV) hydration and lactulose treatment.

Exclusion Criteria:

• Subject has an uncontrolled major psychiatric disorder including major depression orpsychoses as determined by the investigator.
• Subject has been diagnosed with an infection for which they are currently taking oralor parenteral antibiotics, which cannot be discontinued at time of enrollment. Note:Subjects currently taking Rifaximin are not excluded
• Subject shows presence of intestinal obstruction or has inflammatory bowel disease.
• Subject has uncontrolled Type 1 or Type 2 diabetes. Note: Subjects with controlleddiabetes may be enrolled if they are on stable doses of oral hypoglycemic drugs for atleast 3 months prior to screening, and demonstrate clinically acceptable blood glucosecontrol at Baseline, as determined by the investigator.
• Subject has an active malignancy (exceptions: non-melanoma skin cancers).