Trial Outcomes & Findings for Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (NCT NCT02299570)

Last Updated: 2021-01-15

Results Overview

The primary endpoint is to evaluate treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema, of Group A (two enemas of RBX2660) vs. Group B (two enemas of placebo).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

150 participants

Primary outcome timeframe

8 weeks after last assigned study treatment

Results posted on

2021-01-15

Participant Flow

Recruitment was from 12/10/14 to 11/13/15 at 21 medical clinics in the United States and Canada. Recruiment was performed by trained investigators and study coordinators.

Seventeen enrolled subjects did not proceed to randomization and were exited from the study. Of the 133 randomized subjects remaining, five subjects chose to withdraw prior to treatment and in one subject the first blinded enema was not able to be initiated due to anxiety and the subject subsequently chose to withdraw.

Participant milestones

Participant milestones
Measure	Group A Two enemas of RBX2660 administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes	Group B Two enemas of placebo administered 7 days apart Placebo: A suspension of saline and cryoprotectant	Group C 1 enema of RBX2660 and 1 enema of placebo administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes Placebo: A suspension of saline and cryoprotectant
Overall Study STARTED	45	44	44
Overall Study COMPLETED	31	35	25
Overall Study NOT COMPLETED	14	9	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A n=45 Participants Two enemas of RBX2660 administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes	Group B n=44 Participants Two enemas of placebo administered 7 days apart Placebo: A suspension of saline and cryoprotectant	Group C n=44 Participants 1 enema of RBX2660 and 1 enema of placebo administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes Placebo: A suspension of saline and cryoprotectant	Total n=133 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants	69 Participants n=4 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants	19 Participants n=7 Participants	18 Participants n=5 Participants	63 Participants n=4 Participants
Age, Continuous	63.6 years STANDARD_DEVIATION 19.15 • n=5 Participants	58.8 years STANDARD_DEVIATION 19.24 • n=7 Participants	61.0 years STANDARD_DEVIATION 19.69 • n=5 Participants	61.1 years STANDARD_DEVIATION 19.31 • n=4 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	30 Participants n=7 Participants	25 Participants n=5 Participants	81 Participants n=4 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	14 Participants n=7 Participants	19 Participants n=5 Participants	52 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants	42 Participants n=7 Participants	42 Participants n=5 Participants	127 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 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
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants	43 Participants n=7 Participants	42 Participants n=5 Participants	129 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Canada	12 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	28 participants n=4 Participants
Region of Enrollment United States	33 participants n=5 Participants	36 participants n=7 Participants	36 participants n=5 Participants	105 participants n=4 Participants

PRIMARY outcome

Timeframe: 8 weeks after last assigned study treatment

Population: ITT - Subjects in the ITT that were randomized, but not treated, as well as subjects with an "indeterminate" treatment outcome, were also conservatively treated as treatment failures.

Outcome measures

Outcome measures
Measure	Group A n=45 Participants Two enemas of RBX2660 (microbiota suspension) administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes	Group B n=44 Participants Two enemas of placebo administered 7 days apart Placebo: A suspension of saline and cryoprotectant	Group C 1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes Placebo: A suspension of saline and cryoprotectant
Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT) Treatment Success	25 Participants	19 Participants	—
Treatment Success of Group A (2 Doses of RBX2660) vs Group B (2 Doses of Placebo) (ITT) Treatment Failure	20 Participants	25 Participants	—

SECONDARY outcome

Timeframe: 8-weeks

Population: ITT

Treatment Success was defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema

Outcome measures

Outcome measures
Measure	Group A n=44 Participants Two enemas of RBX2660 (microbiota suspension) administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes	Group B n=44 Participants Two enemas of placebo administered 7 days apart Placebo: A suspension of saline and cryoprotectant	Group C 1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes Placebo: A suspension of saline and cryoprotectant
Treatment Success Between Group C (1 Enema of RBX2660 and 1 Enema of Placebo) vs Group B (Two Enemas of Placebo) (ITT) Success	19 Participants	25 Participants	—
Treatment Success Between Group C (1 Enema of RBX2660 and 1 Enema of Placebo) vs Group B (Two Enemas of Placebo) (ITT) Failure	25 Participants	19 Participants	—

SECONDARY outcome

Timeframe: 8-weeks

Population: ITT

Treatment success, defined as the absence of CDAD without the need for retreatment with C. difficile anti-infective therapy or fecal transplant (FT) at 56 days after administration of the last assigned study enema.

Outcome measures

Outcome measures
Measure	Group A n=45 Participants Two enemas of RBX2660 (microbiota suspension) administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes	Group B n=44 Participants Two enemas of placebo administered 7 days apart Placebo: A suspension of saline and cryoprotectant	Group C 1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes Placebo: A suspension of saline and cryoprotectant
Treatment Success Evaluated Between Group A (Two Enemas of RBX2660) Versus Group C (1 Enema of RBX2660 and 1 Enema of Placebo) (ITT) Success	25 Participants	25 Participants	—
Treatment Success Evaluated Between Group A (Two Enemas of RBX2660) Versus Group C (1 Enema of RBX2660 and 1 Enema of Placebo) (ITT) Failure	20 Participants	19 Participants	—

SECONDARY outcome

Timeframe: 8-week

Population: ITT

The validated SF-36 scale was used to identify changes to quality of life (QoL) following study treatment. Each component is analyzed on a norm-based scoring (0-100) with a higher score representing an improvement in QoL.

Outcome measures

Outcome measures
Measure	Group A n=45 Participants Two enemas of RBX2660 (microbiota suspension) administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes	Group B n=44 Participants Two enemas of placebo administered 7 days apart Placebo: A suspension of saline and cryoprotectant	Group C n=44 Participants 1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes Placebo: A suspension of saline and cryoprotectant
SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) Physical Comp Baseline	39.4 Score on a scale Standard Deviation 11.4	39.4 Score on a scale Standard Deviation 9.7	43.4 Score on a scale Standard Deviation 10.5
SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) Physical Comp Week 1	44.3 Score on a scale Standard Deviation 10.2	45.0 Score on a scale Standard Deviation 9.7	46.4 Score on a scale Standard Deviation 10.1
SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) Physical Comp Week 4	44.9 Score on a scale Standard Deviation 11.6	45.6 Score on a scale Standard Deviation 10.2	46.1 Score on a scale Standard Deviation 11.2
SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) Physical Comp Week 8	43.9 Score on a scale Standard Deviation 10.9	45.8 Score on a scale Standard Deviation 10.6	46.5 Score on a scale Standard Deviation 12.1
SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) Mental Comp Baseline	44.6 Score on a scale Standard Deviation 13.5	42.5 Score on a scale Standard Deviation 11.5	45.0 Score on a scale Standard Deviation 11.9
SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) Mental Comp Week 1	51.8 Score on a scale Standard Deviation 10.5	51.2 Score on a scale Standard Deviation 10.3	50.6 Score on a scale Standard Deviation 8.2
SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) Mental Comp Week 4	53.5 Score on a scale Standard Deviation 10.7	48.2 Score on a scale Standard Deviation 12.4	51.5 Score on a scale Standard Deviation 6.4
SF-36 Scores Obtained at the 1-week, 4-week, and 8-week Assessments Visits During the Double-blind Period as Compared to Baseline (ITT) Mental Comp Week 8	52.1 Score on a scale Standard Deviation 10.8	49.8 Score on a scale Standard Deviation 11.7	51.2 Score on a scale Standard Deviation 7.6

SECONDARY outcome

Timeframe: 8-weeks

Population: ITT

Time to CDI Recurrence was evaluated using Kaplan-Meier Analysis and expressed by percentage of subjects who were recurrence free at a certain time point (every 7 days) from completion of the last blinded enema.

Outcome measures

Outcome measures
Measure	Group A n=45 Participants Two enemas of RBX2660 (microbiota suspension) administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes	Group B n=44 Participants Two enemas of placebo administered 7 days apart Placebo: A suspension of saline and cryoprotectant	Group C 1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes Placebo: A suspension of saline and cryoprotectant
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) % Recurrence Free by Day 0	91.1 percentage of participants	100 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) % Recurrence Free by Day 7	73.3 percentage of participants	77.3 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) % Recurrence Free by Day 14	66.7 percentage of participants	63.6 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) % Recurrence Free by Day 21	60.0 percentage of participants	61.4 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) % Recurrence Free by Day 28	60.0 percentage of participants	56.8 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) % Recurrence Free by Day 35	57.8 percentage of participants	52.3 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) % Recurrence Free by Day 42	57.8 percentage of participants	50.0 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) % Recurrence Free by Day 49	55.5 percentage of participants	47.6 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group B (ITT) % Recurrence Free by Day 56	55.5 percentage of participants	42.2 percentage of participants	—

SECONDARY outcome

Timeframe: 8-weeks

Population: ITT

Outcome measures

Outcome measures
Measure	Group A n=44 Participants Two enemas of RBX2660 (microbiota suspension) administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes	Group B n=44 Participants Two enemas of placebo administered 7 days apart Placebo: A suspension of saline and cryoprotectant	Group C 1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes Placebo: A suspension of saline and cryoprotectant
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) % Recurrence Free by 2nd Enema	95.5 percentage of participants	100 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) % Recurrence Free by Day 7	76.9 percentage of participants	77.3 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) % Recurrence Free by Day 14	69.9 percentage of participants	63.6 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) % Recurrence Free by Day 21	62.9 percentage of participants	61.4 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) % Recurrence Free by Day 28	62.9 percentage of participants	56.8 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) % Recurrence Free by Day 35	60.6 percentage of participants	52.3 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) % Recurrence Free by Day 42	55.9 percentage of participants	50.0 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) % Recurrence Free by Day 49	55.9 percentage of participants	47.6 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group C vs. Group B (ITT) % Recurrence Free by Day 56	55.9 percentage of participants	42.2 percentage of participants	—

SECONDARY outcome

Timeframe: 8-weeks

Population: ITT

Outcome measures

Outcome measures
Measure	Group A n=45 Participants Two enemas of RBX2660 (microbiota suspension) administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes	Group B n=44 Participants Two enemas of placebo administered 7 days apart Placebo: A suspension of saline and cryoprotectant	Group C 1 enema of RBX2660 (microbiota suspension) and 1 enema of placebo administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes Placebo: A suspension of saline and cryoprotectant
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) % Recurrence Free by 2nd Enema	91.1 percentage of participants	95.5 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) % Recurrence Free by Day 7	73.3 percentage of participants	76.9 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) % Recurrence Free by Day 14	66.7 percentage of participants	69.9 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) % Recurrence Free by Day 21	60.0 percentage of participants	62.9 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) % Recurrence Free by Day 28	60.0 percentage of participants	62.9 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) % Recurrence Free by Day 35	57.8 percentage of participants	60.6 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) % Recurrence Free by Day 42	57.8 percentage of participants	55.9 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) % Recurrence Free by Day 49	55.5 percentage of participants	55.9 percentage of participants	—
Time to CDAD Recurrence After Completion of the Assigned Study Treatment for Group A vs. Group C (ITT) % Recurrence Free by Day 56	55.5 percentage of participants	55.9 percentage of participants	—

Adverse Events

Group A

Serious events: 18 serious events

Other events: 24 other events

Deaths: 7 deaths

Group B

Serious events: 8 serious events

Other events: 19 other events

Deaths: 2 deaths

Group C

Serious events: 12 serious events

Other events: 20 other events

Deaths: 6 deaths

Serious adverse events

Other adverse events

Additional Information

Assoc. Director of Clinical Research

Rebiotix

Phone: 651-705-8778

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Group A n=42 participants at risk Two enemas of RBX2660 administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes	Group B n=44 participants at risk Two enemas of placebo administered 7 days apart Placebo: A suspension of saline and cryoprotectant	Group C n=42 participants at risk 1 enema of RBX2660 and 1 enema of placebo administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes Placebo: A suspension of saline and cryoprotectant
Blood and lymphatic system disorders Anaemia	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Blood and lymphatic system disorders Leukocytosis	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Cardiac disorders Cardiac failure congestive	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 3 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Congenital, familial and genetic disorders Arnold-Chiari malformation	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.3% 1/44 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Abdominal Pain	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.3% 1/44 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Constipation	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Diarrhoea	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.3% 1/44 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Gastrointestinal haemorrhage	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Infections and infestations Osteomyelitis chronic	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Infections and infestations Pneumonia	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Infections and infestations Sepsis	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.3% 1/44 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Infections and infestations Urinary Tract Infection	4.8% 2/42 • Number of events 2 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Metabolism and nutrition disorders Dehydration	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	4.5% 2/44 • Number of events 2 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Metabolism and nutrition disorders Hyponatraemia	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcimoa	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.3% 1/44 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell carcinoma	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.3% 1/44 • Number of events 2 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Nervous system disorders Parkinsonism	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Psychiatric disorders Mental status changes	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Renal and urinary disorders Nephrolithiasis	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.3% 1/44 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 2 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 2 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Infections and infestations Influenza	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.3% 1/44 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Cardiac disorders Angina pectoris	4.8% 2/42 • Number of events 2 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Cardiac disorders Acute myocardial infarction	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Cardiac disorders Myocardial infarction	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.3% 1/44 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Abdominal distension	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.3% 1/44 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Intestinal ischaemia	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Intestinal mass	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Malocclusion	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Small intestinal obstruction	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
General disorders Fatigue	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.3% 1/44 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
General disorders General physical health deterioration	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	4.8% 2/42 • Number of events 2 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
General disorders Pyrexia	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Infections and infestations Clostridium difficile infection	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.3% 1/44 • Number of events 3 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Infections and infestations Appendicitis perforated	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Infections and infestations Bronchitis viral	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.3% 1/44 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.

Other adverse events
Measure	Group A n=42 participants at risk Two enemas of RBX2660 administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes	Group B n=44 participants at risk Two enemas of placebo administered 7 days apart Placebo: A suspension of saline and cryoprotectant	Group C n=42 participants at risk 1 enema of RBX2660 and 1 enema of placebo administered 7 days apart RBX2660 (microbiota suspension): A suspension of intestinal microbes Placebo: A suspension of saline and cryoprotectant
Gastrointestinal disorders Abdominal distension	7.1% 3/42 • Number of events 4 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	6.8% 3/44 • Number of events 3 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	4.8% 2/42 • Number of events 2 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Abdominal Pain	23.8% 10/42 • Number of events 13 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	18.2% 8/44 • Number of events 10 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	19.0% 8/42 • Number of events 9 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Anorectal discomfort	7.1% 3/42 • Number of events 4 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	6.8% 3/44 • Number of events 4 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	4.8% 2/42 • Number of events 2 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Diarrhoea	40.5% 17/42 • Number of events 27 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	15.9% 7/44 • Number of events 10 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	11.9% 5/42 • Number of events 7 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
General disorders Pyrexia	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	6.8% 3/44 • Number of events 3 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	14.3% 6/42 • Number of events 7 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Blood and lymphatic system disorders Anaemia	7.1% 3/42 • Number of events 3 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Nausea	9.5% 4/42 • Number of events 8 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.3% 1/44 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	9.5% 4/42 • Number of events 4 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Constipation	14.3% 6/42 • Number of events 9 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	4.5% 2/44 • Number of events 2 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	7.1% 3/42 • Number of events 3 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Flatulence	9.5% 4/42 • Number of events 4 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	4.5% 2/44 • Number of events 2 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	9.5% 4/42 • Number of events 4 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Haematochezia	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	7.1% 3/42 • Number of events 3 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Gastrointestinal disorders Proctalgia	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	6.8% 3/44 • Number of events 3 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
General disorders Chills	4.8% 2/42 • Number of events 5 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	9.1% 4/44 • Number of events 5 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
General disorders Fatigue	7.1% 3/42 • Number of events 3 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.3% 1/44 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Infections and infestations Urinary Tract Infection	11.9% 5/42 • Number of events 11 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	4.5% 2/44 • Number of events 2 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Injury, poisoning and procedural complications Fall	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.3% 1/44 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	7.1% 3/42 • Number of events 5 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Injury, poisoning and procedural complications Contusion	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	6.8% 3/44 • Number of events 3 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Metabolism and nutrition disorders Dehydration	7.1% 3/42 • Number of events 3 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.3% 1/44 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Nervous system disorders Headache	7.1% 3/42 • Number of events 4 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	4.5% 2/44 • Number of events 2 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	2.4% 1/42 • Number of events 1 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.
Vascular disorders Orthostatic hypotension	7.1% 3/42 • Number of events 3 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/44 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.	0.00% 0/42 • 24 months Data reported here is from the Safety Population, defined as randomized subjects who received any study treatment. The adverse events presented were captured during the double-blind portion of the study. Subjects who were deemed treatment failures had an opportunity to access additional RBX2660 open-label doses, and any open-label treatment emergent adverse events in the open-label period are not presented here.