Trial Outcomes & Findings for Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3) (NCT NCT03244644)

NCT ID: NCT03244644

Last Updated: 2024-07-10

Results Overview

The primary efficacy endpoint was the absence of CDI diarrhea for 8 weeks after study treatment. The model-estimated rate of treatment success, that is the model-estimated percentage of participants that met the primary efficacy endpoint, was estimated using a Bayesian hierarchical model, which formally incorporated data from a previous randomized Phase 2B study (NCT02299570) of RBX2660.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 320 participants
• Primary outcome timeframe: 8 weeks after completing the study treatment
• Results posted on: 2024-07-10

Participant Flow

Recruitment was from July 2017 to February 2020 at 44 medical clinics in the United States and Canada. Recruitment was performed by trained investigators and study coordinators.

A total of 320 subjects were enrolled (signed consent) of which 31 were screen failures. 289 subjects were randomized: 193 to RBX2660 and 96 to placebo. Of the 289, 22 did not receive the allocated treatment. Therefore, a total of 267 subjects were randomized and treated: 180 subjects were treated with blinded RBX2660 treatment and 87 subjects were treated with blinded Placebo treatment.

Participant milestones

Measure	Placebo Placebo is normal saline administered rectally. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding Placebo: Placebo is normal saline solution administered rectally	RBX2660 RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation United States Pharmacopeia (USP) solution and cryoprotectant RBX2660: RBX2660 is a microbiota suspension administered rectally
Overall Study STARTED	87	180
Overall Study COMPLETED	75	159
Overall Study NOT COMPLETED	12	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)

Baseline characteristics by cohort

Measure	Placebo n=87 Participants Placebo is normal saline administered rectally. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding Placebo: Placebo is normal saline solution administered rectally	RBX2660 n=180 Participants RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant RBX2660: RBX2660 is a microbiota suspension administered rectally	Total n=267 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	54 Participants n=5 Participants	91 Participants n=7 Participants	145 Participants n=5 Participants
Age, Categorical >=65 years	33 Participants n=5 Participants	89 Participants n=7 Participants	122 Participants n=5 Participants
Age, Continuous	60.0 years n=5 Participants	64.0 years n=7 Participants	63.0 years n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	123 Participants n=7 Participants	183 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	57 Participants n=7 Participants	84 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	80 Participants n=5 Participants	168 Participants n=7 Participants	248 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 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
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	78 Participants n=5 Participants	168 Participants n=7 Participants	246 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Canada	26 participants n=5 Participants	51 participants n=7 Participants	77 participants n=5 Participants
Region of Enrollment United States	61 participants n=5 Participants	129 participants n=7 Participants	190 participants n=5 Participants
Clostridioides difficile infection (CDI) History <=3	59 Participants n=5 Participants	111 Participants n=7 Participants	170 Participants n=5 Participants
Clostridioides difficile infection (CDI) History >3	28 Participants n=5 Participants	69 Participants n=7 Participants	97 Participants n=5 Participants
Antibiotic Screening Vancomycin alone	78 Participants n=5 Participants	157 Participants n=7 Participants	235 Participants n=5 Participants
Antibiotic Screening Vancomycin in combination	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Antibiotic Screening Fidaxomicin	5 Participants n=5 Participants	12 Participants n=7 Participants	17 Participants n=5 Participants
Antibiotic Screening Other	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks after completing the study treatment

Population: The modified Intent-To-Treat (mITT) Population included all randomized patients who successfully received blinded treatment, excluding those who discontinued from the study for reasons not related to CDI symptoms prior to evaluation of Treatment Success for the primary endpoint.

The primary efficacy endpoint was the absence of CDI diarrhea for 8 weeks after study treatment. The model-estimated rate of treatment success, that is the model-estimated percentage of participants that met the primary efficacy endpoint, was estimated using a Bayesian hierarchical model, which formally incorporated data from a previous randomized Phase 2B study (NCT02299570) of RBX2660.

Outcome measures

Measure	Placebo n=85 Participants Placebo is normal saline administered rectally. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding Placebo: Placebo is normal saline solution administered rectally	RBX2660 n=177 Participants RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant RBX2660: RBX2660 is a microbiota suspension administered rectally
Efficacy of RBX2660 Compared to Placebo Through 8 Weeks	57.5 Model-estimated percent of participants Interval 48.1 to 67.1	70.6 Model-estimated percent of participants Interval 64.1 to 76.8

SECONDARY outcome

Timeframe: 6 months after completing the study treatment

Population: The mITT population included all randomized patients who successfully received blinded treatment, excluding those who discontinued from the study for reasons not related to CDI symptoms prior to evaluation of Treatment Success for the primary endpoint.

The rates of Sustained Clinical Response (i.e., the occurrence of new CDI infections from baseline through 6 months) was assessed by either the rate of new CDI infections after treatment success at 8 weeks (durability) or the frequency of total CDI infections from baseline through 6 months.

Sustained Clinical Response was compared between the RBX2660 group and the control group using a chi-square test. Patients who exited prior to their 6-month follow-up were conservatively counted as a Treatment Failure

Outcome measures

Measure	Placebo n=85 Participants Placebo is normal saline administered rectally. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding Placebo: Placebo is normal saline solution administered rectally	RBX2660 n=177 Participants RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant RBX2660: RBX2660 is a microbiota suspension administered rectally
Sustained Clinical Response Through 6 Months After Blinded Treatment From 8 weeks through 6 months (Durability)	48 Participants	116 Participants
Sustained Clinical Response Through 6 Months After Blinded Treatment Through 6 months	48 Participants	116 Participants

Adverse Events

Placebo Only

Serious events: 5 serious events

Other events: 23 other events

Deaths: 0 deaths

RBX2660 Only

Serious events: 9 serious events

Other events: 56 other events

Deaths: 1 deaths

Blinded Placebo/Open-label RBX2660 (Blinded Period)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Blinded RBX2660/Open-label RBX2660 (Blinded Period)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Blinded Placebo/Open-label RBX2660 (Open-label Period)

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Blinded RBX2660/Open-label RBX2660 (Open-label Period)

Serious events: 5 serious events

Other events: 19 other events

Deaths: 1 deaths

Serious adverse events

Measure	Placebo Only n=63 participants at risk Placebo randomized subjects who did not receive an unblinded RBX2660. Placebo is normal saline administered rectally. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding Placebo: Placebo is normal saline solution administered rectally	RBX2660 Only n=139 participants at risk RBX2660 randomized subjects who did not receive an unblinded RBX2660. RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant RBX2660: RBX2660 is a microbiota suspension administered rectally	Blinded Placebo/Open-label RBX2660 (Blinded Period) n=24 participants at risk Placebo randomized subjects who went on to receive an unblinded RBX2660 (blinded period). Treatment-emergent adverse events (TEAEs) are defined as any adverse events occurring on or after the blinded treatment. For TEAEs counted in open-label treatment period, TEAEs are reported with an onset date on or after the date of the open-label treatment through 6 months timeframe. Placebo is normal saline rectally administered. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding. RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant	Blinded RBX2660/Open-label RBX2660 (Blinded Period) n=41 participants at risk RBX2660 randomized subjects who went on to receive an unblinded RBX2660 (blinded period). Treatment-emergent adverse events (TEAEs) are defined as any adverse events occurring on or after the blinded treatment. For TEAEs counted in open-label treatment period, TEAEs are reported with an onset date on or after the date of the open-label treatment through 6 months timeframe. Placebo is normal saline rectally administered. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding. RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant	Blinded Placebo/Open-label RBX2660 (Open-label Period) n=24 participants at risk Placebo randomized subjects who went on to receive an unblinded RBX2660 (open-label period). Treatment-emergent adverse events (TEAEs) are defined as any adverse events occurring on or after the blinded treatment. For TEAEs counted in open-label treatment period, TEAEs are reported with an onset date on or after the date of the open-label treatment through 6 months timeframe. Placebo is normal saline rectally administered. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding. RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant	Blinded RBX2660/Open-label RBX2660 (Open-label Period) n=41 participants at risk RBX2660 randomized subjects who went on to receive an unblinded RBX2660 (open-label period). Treatment-emergent adverse events (TEAEs) are defined as any adverse events occurring on or after the blinded treatment. For TEAEs counted in open-label treatment period, TEAEs are reported with an onset date on or after the date of the open-label treatment through 6 months timeframe. Placebo is normal saline rectally administered. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding. RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant
Gastrointestinal disorders Abdominal pain upper	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/139 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	4.2% 1/24 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Gastrointestinal disorders Colitis	1.6% 1/63 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/139 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Gastrointestinal disorders Diarrhoea	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.72% 1/139 • Number of events 2 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Gastrointestinal disorders Gastric ulcer	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/139 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	4.2% 1/24 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Gastrointestinal disorders Gastritis alcoholic	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/139 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	4.2% 1/24 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Cardiac disorders Cardiac failure congestive	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/139 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	2.4% 1/41 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Cardiac disorders Cardio-respiratory arrest	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.72% 1/139 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Gastrointestinal disorders Abdominal pain	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	1.4% 2/139 • Number of events 2 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Gastrointestinal disorders Ileus	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.72% 1/139 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Gastrointestinal disorders Nausea	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.72% 1/139 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Gastrointestinal disorders Vomiting	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.72% 1/139 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
General disorders Asthenia	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.72% 1/139 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
General disorders Gait disturbance	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.72% 1/139 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
General disorders Multimorbidity	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/139 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	2.4% 1/41 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Infections and infestations Abdominal abscess	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.72% 1/139 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Infections and infestations Bacteraemia	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/139 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	2.4% 1/41 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Infections and infestations Cellulitis	3.2% 2/63 • Number of events 2 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/139 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Infections and infestations Clostridium difficile colitis	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.72% 1/139 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	2.4% 1/41 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	2.4% 1/41 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Infections and infestations Clostridium difficile infection	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	1.4% 2/139 • Number of events 2 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	2.4% 1/41 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	4.9% 2/41 • Number of events 2 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Infections and infestations Gastroenteritis	1.6% 1/63 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/139 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Infections and infestations Sepsis	1.6% 1/63 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/139 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Injury, poisoning and procedural complications Alcohol poisoning	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/139 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	2.4% 1/41 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.72% 1/139 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.72% 1/139 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.72% 1/139 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/139 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	2.4% 1/41 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Metabolism and nutrition disorders Dehydration	1.6% 1/63 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/139 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	4.2% 1/24 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.72% 1/139 • Number of events 3 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/139 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	4.2% 1/24 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.72% 1/139 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/139 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	4.2% 1/24 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	2.4% 1/41 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	4.2% 1/24 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Psychiatric disorders Confusional state	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.72% 1/139 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Psychiatric disorders Depression	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.72% 1/139 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Psychiatric disorders Suicidal ideation	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/139 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	4.2% 1/24 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Renal and urinary disorders Acute kidney injury	1.6% 1/63 • Number of events 2 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.72% 1/139 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.6% 1/63 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/139 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.72% 1/139 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Vascular disorders Hypotension	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/139 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	2.4% 1/41 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.

Other adverse events

Measure	Placebo Only n=63 participants at risk Placebo randomized subjects who did not receive an unblinded RBX2660. Placebo is normal saline administered rectally. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding Placebo: Placebo is normal saline solution administered rectally	RBX2660 Only n=139 participants at risk RBX2660 randomized subjects who did not receive an unblinded RBX2660. RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant RBX2660: RBX2660 is a microbiota suspension administered rectally	Blinded Placebo/Open-label RBX2660 (Blinded Period) n=24 participants at risk Placebo randomized subjects who went on to receive an unblinded RBX2660 (blinded period). Treatment-emergent adverse events (TEAEs) are defined as any adverse events occurring on or after the blinded treatment. For TEAEs counted in open-label treatment period, TEAEs are reported with an onset date on or after the date of the open-label treatment through 6 months timeframe. Placebo is normal saline rectally administered. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding. RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant	Blinded RBX2660/Open-label RBX2660 (Blinded Period) n=41 participants at risk RBX2660 randomized subjects who went on to receive an unblinded RBX2660 (blinded period). Treatment-emergent adverse events (TEAEs) are defined as any adverse events occurring on or after the blinded treatment. For TEAEs counted in open-label treatment period, TEAEs are reported with an onset date on or after the date of the open-label treatment through 6 months timeframe. Placebo is normal saline rectally administered. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding. RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant	Blinded Placebo/Open-label RBX2660 (Open-label Period) n=24 participants at risk Placebo randomized subjects who went on to receive an unblinded RBX2660 (open-label period). Treatment-emergent adverse events (TEAEs) are defined as any adverse events occurring on or after the blinded treatment. For TEAEs counted in open-label treatment period, TEAEs are reported with an onset date on or after the date of the open-label treatment through 6 months timeframe. Placebo is normal saline rectally administered. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding. RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant	Blinded RBX2660/Open-label RBX2660 (Open-label Period) n=41 participants at risk RBX2660 randomized subjects who went on to receive an unblinded RBX2660 (open-label period). Treatment-emergent adverse events (TEAEs) are defined as any adverse events occurring on or after the blinded treatment. For TEAEs counted in open-label treatment period, TEAEs are reported with an onset date on or after the date of the open-label treatment through 6 months timeframe. Placebo is normal saline rectally administered. Packaging and labeling are identical to the packaging and labeling for RBX2660 to support the study blinding. RBX2660 is a rectally administered microbiota suspension in a 0.9% sodium chloride irrigation USP solution and cryoprotectant
Gastrointestinal disorders Flatulence	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	5.8% 8/139 • Number of events 10 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	4.2% 1/24 • Number of events 3 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	2.4% 1/41 • Number of events 3 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	12.5% 3/24 • Number of events 4 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Gastrointestinal disorders Nausea	4.8% 3/63 • Number of events 3 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	10.1% 14/139 • Number of events 15 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	4.2% 1/24 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	2.4% 1/41 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	12.5% 3/24 • Number of events 3 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Gastrointestinal disorders Vomiting	6.3% 4/63 • Number of events 4 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	2.2% 3/139 • Number of events 4 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Infections and infestations Upper respiratory tract infection	4.8% 3/63 • Number of events 3 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	2.2% 3/139 • Number of events 4 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	7.3% 3/41 • Number of events 3 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Infections and infestations Urinary tract infection	3.2% 2/63 • Number of events 3 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	3.6% 5/139 • Number of events 7 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	14.6% 6/41 • Number of events 8 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Gastrointestinal disorders Abdominal distension	4.8% 3/63 • Number of events 3 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	5.8% 8/139 • Number of events 11 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	4.9% 2/41 • Number of events 2 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	8.3% 2/24 • Number of events 2 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	2.4% 1/41 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Gastrointestinal disorders Abdominal pain	7.9% 5/63 • Number of events 5 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	17.3% 24/139 • Number of events 27 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	16.7% 4/24 • Number of events 4 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	2.4% 1/41 • Number of events 2 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	8.3% 2/24 • Number of events 3 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	9.8% 4/41 • Number of events 4 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Gastrointestinal disorders Constipation	6.3% 4/63 • Number of events 4 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	3.6% 5/139 • Number of events 6 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	4.2% 1/24 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	2.4% 1/41 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Gastrointestinal disorders Diarrhoea	19.0% 12/63 • Number of events 12 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	20.1% 28/139 • Number of events 40 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	8.3% 2/24 • Number of events 2 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	2.4% 1/41 • Number of events 2 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	20.8% 5/24 • Number of events 5 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	22.0% 9/41 • Number of events 12 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Infections and infestations Viral upper respiratory tract infection	1.6% 1/63 • Number of events 1 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	5.8% 8/139 • Number of events 8 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	8.3% 2/24 • Number of events 2 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.
Psychiatric disorders Depression	0.00% 0/63 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	2.9% 4/139 • Number of events 4 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/41 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	0.00% 0/24 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.	7.3% 3/41 • Number of events 3 • Adverse Events were collected from enrollment through 6 months after the last dose received, which may have been blinded placebo, blinded RBX2660 or an open label dose of RBX2660. Treatment emergent adverse events, defined as adverse events occurring after exposure to the study drug (placebo or RBX2660) are presented. Participants were systematically asked about any occurrences of adverse events at each contact point (in office or scheduled phone call) and via a daily diary for one week after each dose.

Additional Information

Clinical Development

Rebiotix inc, a Ferring Company

Phone: 651-705-8778

Email: US8-StudyInfo@ferring.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60