Trial Outcomes & Findings for Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE) (NCT NCT03515044)

NCT ID: NCT03515044

Last Updated: 2023-04-13

Results Overview

A participant was considered to have an overt HE episode if at least one of the following applied: (1) Disorientated to time or place or person, (2) Lethargic and has asterixis, (3) Inability to assess the patient due to disorientation to time and place and person; and/or somnolence, and/or coma. Severity of OHE episodes was graded using the HEGI scale, where Grade 1 is no clinical findings of OHE, and Grade 4 is comatose. Higher scores on the scale have higher severity (worse outcome).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 71 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2023-04-13

Participant Flow

Participants were randomized into 5 possible double-blind treatment arms during the Double-Blind Period. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg.

Participant milestones

Measure	Cohort 1 40 mg Rifaximin SSD Once Daily 40 mg Rifaximin immediate release (IR) rifaximin SSD once daily (QD) and lactulose 40 mg Rifaximin SSD once daily: SSD once daily (QD) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 2 40 mg Rifaximin SSD Twice Daily 40 mg Rifaximin immediate release (IR) rifaximin SSD twice daily (BID) and lactulose 40 mg Rifaximin SSD twice daily: SSD twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 3 80 mg Rifaximin SSD Once Daily 80 mg Rifaximin sustained extended release (SER) rifaximin SSD once daily (QD) and lactulose 80 mg Rifaximin SSD once daily: SSD once daily (QD) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 4 80 mg Rifaximin SSD Twice Daiy Cohort 4 80 mg Rifaximin SSD twice daily (BID) and lactulose 80 mg Rifaximin SSD twice daily: SSD twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 5 Placebo Twice Daily SSD placebo twice daily (BID) and lactulose Placebo: Administered twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.	Open-Label Rifaximin 550 mg After completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period
Double-Blind Period STARTED	15	15	14	13	14	0
Double-Blind Period COMPLETED	13	13	8	11	8	0
Double-Blind Period NOT COMPLETED	2	2	6	2	6	0
Open-label Extension Period STARTED	0	0	0	0	0	53
Open-label Extension Period COMPLETED	0	0	0	0	0	31
Open-label Extension Period NOT COMPLETED	0	0	0	0	0	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Cohort 1 40 mg Rifaximin SSD Once Daily n=15 Participants 40 mg Rifaximin immediate release (IR) rifaximin SSD once daily (QD) and lactulose 40 mg Rifaximin SSD once daily: SSD once daily (QD) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 2 40 mg Rifaximin SSD Twice Daily n=15 Participants 40 mg Rifaximin immediate release (IR) rifaximin SSD twice daily (BID) and lactulose 40 mg Rifaximin SSD twice daily: SSD twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 3 80 mg Rifaximin SSD Once Daily n=14 Participants 80 mg Rifaximin sustained extended release (SER) rifaximin SSD once daily (QD) and lactulose 80 mg Rifaximin SSD once daily: SSD once daily (QD) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 4 80 mg Rifaximin SSD Twice Daiy n=13 Participants Cohort 4 80 mg Rifaximin SSD twice daily (BID) and lactulose 80 mg Rifaximin SSD twice daily: SSD twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 5 Placebo Twice Daily n=14 Participants SSD placebo twice daily (BID) and lactulose Placebo: Administered twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.	Total n=71 Participants Total of all reporting groups
Age, Continuous	61.3 years STANDARD_DEVIATION 14.88 • n=5 Participants	61.1 years STANDARD_DEVIATION 8.02 • n=7 Participants	63.0 years STANDARD_DEVIATION 7.94 • n=5 Participants	61.8 years STANDARD_DEVIATION 8.07 • n=4 Participants	60.0 years STANDARD_DEVIATION 9.25 • n=21 Participants	61.4 years STANDARD_DEVIATION 9.84 • n=10 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	2 Participants n=21 Participants	33 Participants n=10 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	12 Participants n=21 Participants	38 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	10 Participants n=10 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	10 Participants n=4 Participants	9 Participants n=21 Participants	56 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants

PRIMARY outcome

Timeframe: 14 days

A participant was considered to have an overt HE episode if at least one of the following applied: (1) Disorientated to time or place or person, (2) Lethargic and has asterixis, (3) Inability to assess the patient due to disorientation to time and place and person; and/or somnolence, and/or coma. Severity of OHE episodes was graded using the HEGI scale, where Grade 1 is no clinical findings of OHE, and Grade 4 is comatose. Higher scores on the scale have higher severity (worse outcome).

Outcome measures

Measure	Cohort 1 40 mg Rifaximin SSD Once Daily n=15 Participants 40 mg Rifaximin immediate release (IR) rifaximin SSD once daily (QD) and lactulose 40 mg Rifaximin SSD once daily: SSD once daily (QD) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 2 40 mg Rifaximin SSD Twice Daily n=15 Participants 40 mg Rifaximin immediate release (IR) rifaximin SSD twice daily (BID) and lactulose 40 mg Rifaximin SSD twice daily: SSD twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 3 80 mg Rifaximin SSD Once Daily n=14 Participants 80 mg Rifaximin sustained extended release (SER) rifaximin SSD once daily (QD) and lactulose 80 mg Rifaximin SSD once daily: SSD once daily (QD) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 4 80 mg Rifaximin SSD Twice Daiy n=13 Participants Cohort 4 80 mg Rifaximin SSD twice daily (BID) and lactulose 80 mg Rifaximin SSD twice daily: SSD twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 5 Placebo Twice Daily n=14 Participants SSD placebo twice daily (BID) and lactulose Placebo: Administered twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.
Time to Overt Hepatic Encephalopathy (OHE) Resolution Determined Using the Hepatic Encephalopathy Grading Instrument (HEGI), Defined as HEGI Score < 2	36.1 hours Interval 12.07 to 63.5	21.1 hours Interval 13.05 to 47.68	45.9 hours Interval 22.75 to 80.37	17.9 hours Interval 11.68 to 58.75	62.7 hours Interval 20.0 to 168.88

SECONDARY outcome

Timeframe: 14 days

A participant was considered to have an overt HE episode if at least one of the following applied: (1) Disorientated to time or place or person, (2) Lethargic and has asterixis, (3) Inability to assess the patient due to disorientation to time and place and person; and/or somnolence, and/or coma. Severity of OHE episodes was graded using the HEGI scale, where Grade 1 is no clinical findings of OHE, and Grade 4 is comatose. Higher scores on the scale have higher severity (worse outcome).

Outcome measures

Measure	Cohort 1 40 mg Rifaximin SSD Once Daily n=15 Participants 40 mg Rifaximin immediate release (IR) rifaximin SSD once daily (QD) and lactulose 40 mg Rifaximin SSD once daily: SSD once daily (QD) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 2 40 mg Rifaximin SSD Twice Daily n=15 Participants 40 mg Rifaximin immediate release (IR) rifaximin SSD twice daily (BID) and lactulose 40 mg Rifaximin SSD twice daily: SSD twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 3 80 mg Rifaximin SSD Once Daily n=14 Participants 80 mg Rifaximin sustained extended release (SER) rifaximin SSD once daily (QD) and lactulose 80 mg Rifaximin SSD once daily: SSD once daily (QD) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 4 80 mg Rifaximin SSD Twice Daiy n=13 Participants Cohort 4 80 mg Rifaximin SSD twice daily (BID) and lactulose 80 mg Rifaximin SSD twice daily: SSD twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 5 Placebo Twice Daily n=14 Participants SSD placebo twice daily (BID) and lactulose Placebo: Administered twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.
Time to Improvement in Hepatic Encephalopathy Grading Instrument (HEGI) Score, Defined as at Least One Grade Decrease (Improvement)	2.5 days Interval 2.0 to 4.0	2.0 days Confidence intervals could not be calculated for Cohort 2, due to lack of variation in the time to event.	2.0 days Interval 2.0 to 4.0	2.0 days Interval 2.0 to 4.0	3.0 days Interval 2.0 to 8.0

SECONDARY outcome

Timeframe: 14 days

Time in days until discharge from the hospital

Outcome measures

Measure	Cohort 1 40 mg Rifaximin SSD Once Daily n=15 Participants 40 mg Rifaximin immediate release (IR) rifaximin SSD once daily (QD) and lactulose 40 mg Rifaximin SSD once daily: SSD once daily (QD) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 2 40 mg Rifaximin SSD Twice Daily n=15 Participants 40 mg Rifaximin immediate release (IR) rifaximin SSD twice daily (BID) and lactulose 40 mg Rifaximin SSD twice daily: SSD twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 3 80 mg Rifaximin SSD Once Daily n=14 Participants 80 mg Rifaximin sustained extended release (SER) rifaximin SSD once daily (QD) and lactulose 80 mg Rifaximin SSD once daily: SSD once daily (QD) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 4 80 mg Rifaximin SSD Twice Daiy n=13 Participants Cohort 4 80 mg Rifaximin SSD twice daily (BID) and lactulose 80 mg Rifaximin SSD twice daily: SSD twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 5 Placebo Twice Daily n=14 Participants SSD placebo twice daily (BID) and lactulose Placebo: Administered twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.
Time to Hospital Discharge	3.0 days Interval 2.0 to 4.0	3.0 days Interval 2.0 to 4.0	3.0 days Interval 2.0 to 4.0	4.0 days Interval 3.0 to 4.0	4.5 days Interval 2.0 to 6.0

Adverse Events

Cohort 1 40 mg Rifaximin SSD Once Daily

Serious events: 3 serious events

Other events: 2 other events

Deaths: 2 deaths

Cohort 2 40 mg Rifaximin SSD Twice Daily

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort 3 80 mg Rifaximin SSD Once Daily

Serious events: 3 serious events

Other events: 4 other events

Deaths: 2 deaths

Cohort 4 80 mg Rifaximin SSD Twice Daiy

Serious events: 1 serious events

Other events: 5 other events

Deaths: 1 deaths

Cohort 5 Placebo Twice Daily

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Open-label Rifaximin 550 mg

Serious events: 33 serious events

Other events: 5 other events

Deaths: 13 deaths

Serious adverse events

Measure	Cohort 1 40 mg Rifaximin SSD Once Daily n=15 participants at risk 40 mg Rifaximin immediate release (IR) rifaximin SSD once daily (QD) and lactulose 40 mg Rifaximin SSD once daily: SSD once daily (QD) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 2 40 mg Rifaximin SSD Twice Daily n=15 participants at risk 40 mg Rifaximin immediate release (IR) rifaximin SSD twice daily (BID) and lactulose 40 mg Rifaximin SSD twice daily: SSD twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 3 80 mg Rifaximin SSD Once Daily n=14 participants at risk 80 mg Rifaximin sustained extended release (SER) rifaximin SSD once daily (QD) and lactulose 80 mg Rifaximin SSD once daily: SSD once daily (QD) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 4 80 mg Rifaximin SSD Twice Daiy n=13 participants at risk Cohort 4 80 mg Rifaximin SSD twice daily (BID) and lactulose 80 mg Rifaximin SSD twice daily: SSD twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 5 Placebo Twice Daily n=14 participants at risk SSD placebo twice daily (BID) and lactulose Placebo: Administered twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.	Open-label Rifaximin 550 mg n=53 participants at risk After completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period
Blood and lymphatic system disorders Anemia	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	3.8% 2/53 • Number of events 2 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Cardiac disorders Angina pectoris	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Cardiac disorders Cardiac arrest	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Cardiac disorders Cardiac distress	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Cardiac disorders Tachycardia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Gastrointestinal disorders Abominal Pain	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.7% 1/13 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	14.3% 2/14 • Number of events 2 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	3.8% 2/53 • Number of events 2 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Gastrointestinal disorders Haematochezia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Gastrointestinal disorders Nausea	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	3.8% 2/53 • Number of events 2 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Gastrointestinal disorders Vomiting	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	3.8% 2/53 • Number of events 2 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
General disorders Asthenia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
General disorders Multiple organ dysfunction syndrome	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
General disorders Pyrexia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Hepatobiliary disorders Chronic hepatic failure	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Hepatobiliary disorders Cirrhosis alcoholic	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	3.8% 2/53 • Number of events 2 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Hepatobiliary disorders Hepatic failure	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Hepatobiliary disorders Hepatorenal syndrome	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Infections and infestations Bacteremia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.7% 1/13 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Infections and infestations Kidney infection	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	3.8% 2/53 • Number of events 2 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Infections and infestations Peritonitis bacterial	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Infections and infestations Pneumonia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	3.8% 2/53 • Number of events 2 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Infections and infestations Sepsis	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Infections and infestations Septic shock	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	14.3% 2/14 • Number of events 2 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	3.8% 2/53 • Number of events 2 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Infections and infestations Urinary tract infection	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Investigations Blood creatinine increased	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Metabolism and nutrition disorders Hyochloraemia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Nervous system disorders Cerebral artery embolism	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Nervous system disorders Hepatic encephalopathy	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	24.5% 13/53 • Number of events 13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Psychiatric disorders Confusional state	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	5.7% 3/53 • Number of events 5 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Psychiatric disorders Mental status changes	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	5.7% 3/53 • Number of events 3 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Renal and urinary disorders Acute kidney injury	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.7% 1/13 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	3.8% 2/53 • Number of events 2 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Renal and urinary disorders Dysuria	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	3.8% 2/53 • Number of events 2 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Vascular disorders Hypotension	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.

Other adverse events

Measure	Cohort 1 40 mg Rifaximin SSD Once Daily n=15 participants at risk 40 mg Rifaximin immediate release (IR) rifaximin SSD once daily (QD) and lactulose 40 mg Rifaximin SSD once daily: SSD once daily (QD) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 2 40 mg Rifaximin SSD Twice Daily n=15 participants at risk 40 mg Rifaximin immediate release (IR) rifaximin SSD twice daily (BID) and lactulose 40 mg Rifaximin SSD twice daily: SSD twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 3 80 mg Rifaximin SSD Once Daily n=14 participants at risk 80 mg Rifaximin sustained extended release (SER) rifaximin SSD once daily (QD) and lactulose 80 mg Rifaximin SSD once daily: SSD once daily (QD) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 4 80 mg Rifaximin SSD Twice Daiy n=13 participants at risk Cohort 4 80 mg Rifaximin SSD twice daily (BID) and lactulose 80 mg Rifaximin SSD twice daily: SSD twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.	Cohort 5 Placebo Twice Daily n=14 participants at risk SSD placebo twice daily (BID) and lactulose Placebo: Administered twice daily (BID) and lactulose lactulose: to be taken in the recommended adult size dosage.	Open-label Rifaximin 550 mg n=53 participants at risk After completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period
Cardiac disorders Arrhythmia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.7% 1/13 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Cardiac disorders Coronary artery disease	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Cardiac disorders Tachycardia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Eye disorders Vomiting	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Gastrointestinal disorders Abdominal pain	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.7% 1/13 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Gastrointestinal disorders Constipation	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Gastrointestinal disorders Dysphagia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Gastrointestinal disorders Ileus	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Gastrointestinal disorders Nausea	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Gastrointestinal disorders Umbilical hernia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Hepatobiliary disorders Hepatorenal syndrome	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Infections and infestations Clostridium difficile	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.7% 1/13 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Infections and infestations Sinusitis	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Infections and infestations Sinusitis fungal	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Infections and infestations Urinary tract infection	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.7% 1/13 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	3.8% 2/53 • Number of events 2 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Metabolism and nutrition disorders Dehydration	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	15.4% 2/13 • Number of events 2 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Nervous system disorders Dementia	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Nervous system disorders Hepatic encephalopathy	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Renal and urinary disorders Acute kidney injury	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Renal and urinary disorders Renal failure	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.7% 1/13 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	7.1% 1/14 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/53 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	6.7% 1/15 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/15 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/13 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	0.00% 0/14 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.	1.9% 1/53 • Number of events 1 • Participants were randomized into 5 possible double-blind treatment arms (Cohorts 1 to 5) during the Double-Blind Period, in which adverse events were assessed up to 14 days. Upon completion of the Double-Blind Period, participants could continue in the 30 day Open-Label Extension Period in which all participants received rifaximin 550 mg. Adverse events were monitored/assessed up to a total of 44 days.

Additional Information

Study Director

Bausch Health Americas, Inc

Phone: 19083009920

Email: susan.harris@bauschhealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee Contact sponsor for details.
• Publication restrictions are in place

Restriction type: OTHER