Trial Outcomes & Findings for Microbiota or Placebo After Antimicrobial Therapy for Recurrent C. Difficile at Home (MATCH) (NCT NCT03005379)

Last Updated: 2024-04-11

Results Overview

The primary outcome is recurrent CDI (definite or possible) or death within 56 days of randomization. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. A definite CDI recurrence is defined as a potential CDI recurrence with symptom (more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy) plus laboratory confirmation of C. difficile from a stool specimen by toxin Enzyme Immunoassays (EIA) test.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

153 participants

Primary outcome timeframe

Within 56 days of randomization

Results posted on

2024-04-11

Participant Flow

The study did not contain pre-assignment.

Participant milestones

Participant milestones
Measure	Fecal Microbiota Therapy Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT	Placebo Placebo Placebo: Oral capsule-delivered placebo
Overall Study STARTED	76	77
Overall Study COMPLETED	76	76
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

baseline labs were not available for a few participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fecal Microbiota Therapy (FMT) n=76 Participants Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT	Placebo n=77 Participants Placebo Placebo: Oral capsule-delivered placebo	Total n=153 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=76 Participants	0 Participants n=77 Participants	0 Participants n=153 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=76 Participants	33 Participants n=77 Participants	53 Participants n=153 Participants
Age, Categorical >=65 years	56 Participants n=76 Participants	44 Participants n=77 Participants	100 Participants n=153 Participants
Age, Continuous	69.2 years STANDARD_DEVIATION 12.31 • n=76 Participants	63.9 years STANDARD_DEVIATION 14.63 • n=77 Participants	66.5 years STANDARD_DEVIATION 13.74 • n=153 Participants
Sex: Female, Male Female	8 Participants n=76 Participants	13 Participants n=77 Participants	21 Participants n=153 Participants
Sex: Female, Male Male	68 Participants n=76 Participants	64 Participants n=77 Participants	132 Participants n=153 Participants
Race/Ethnicity, Customized Race : White	70 participants n=76 Participants	75 participants n=77 Participants	145 participants n=153 Participants
Race/Ethnicity, Customized Race : African-American or Black	6 participants n=76 Participants	2 participants n=77 Participants	8 participants n=153 Participants
Race/Ethnicity, Customized Race : American Indian or Alaska Native	3 participants n=76 Participants	0 participants n=77 Participants	3 participants n=153 Participants
Race/Ethnicity, Customized Race : Native Hawaiian or Other Pacific Islander	0 participants n=76 Participants	0 participants n=77 Participants	0 participants n=153 Participants
Race/Ethnicity, Customized Race : Chinese	0 participants n=76 Participants	0 participants n=77 Participants	0 participants n=153 Participants
Race/Ethnicity, Customized Race : Japanese	0 participants n=76 Participants	0 participants n=77 Participants	0 participants n=153 Participants
Race/Ethnicity, Customized Race : Filipino	0 participants n=76 Participants	0 participants n=77 Participants	0 participants n=153 Participants
Race/Ethnicity, Customized Race : Asian Indian	0 participants n=76 Participants	0 participants n=77 Participants	0 participants n=153 Participants
Race/Ethnicity, Customized Race : Other Asian	0 participants n=76 Participants	0 participants n=77 Participants	0 participants n=153 Participants
Race/Ethnicity, Customized Race : Other Race	1 participants n=76 Participants	0 participants n=77 Participants	1 participants n=153 Participants
Region of Enrollment United States	76 participants n=76 Participants	77 participants n=77 Participants	153 participants n=153 Participants
Albumin	3.7 g/dL STANDARD_DEVIATION 0.6 • n=71 Participants • baseline labs were not available for a few participants	3.9 g/dL STANDARD_DEVIATION 0.6 • n=71 Participants • baseline labs were not available for a few participants	3.8 g/dL STANDARD_DEVIATION 0.6 • n=142 Participants • baseline labs were not available for a few participants

PRIMARY outcome

Timeframe: Within 56 days of randomization

Population: All randomized participants are analyzed according to the principle of intent-to-treat.

Outcome measures

Outcome measures
Measure	Fecal Microbiota Therapy (FMT) n=76 Participants Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT	Placebo n=77 Participants Placebo Placebo: Oral capsule-delivered placebo
Possible or Definite Recurrent Clostridium Difficile Infection (CDI), or Death	25 Participants	23 Participants

SECONDARY outcome

Timeframe: Within 6 months of randomization

Population: Intent-to-treat

A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. A definite CDI recurrence is defined as a potential CDI recurrence with symptom (more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy) plus laboratory confirmation of C. difficile from a stool specimen by EIA toxin test.

Outcome measures

Outcome measures
Measure	Fecal Microbiota Therapy (FMT) n=76 Participants Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT	Placebo n=77 Participants Placebo Placebo: Oral capsule-delivered placebo
Recurrent CDI (Definite or Possible) or Death Within 6 Months of Randomization.	32 Participants	31 Participants

SECONDARY outcome

Timeframe: 56 days from randomization

Population: Intent-to-treat \& complete-case

The investigators will use a brief assessment of both overall and gastrointestinal health status, a previously validated instrument called Gastrointestinal Quality of Life Index (GIQLI). GIQLI takes value between 0 and 144, with higher score associated with better quality of life.

Outcome measures

Outcome measures
Measure	Fecal Microbiota Therapy (FMT) n=72 Participants Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT	Placebo n=69 Participants Placebo Placebo: Oral capsule-delivered placebo
Quality of Life at 56 Day	111.42 units on a scale Standard Deviation 21.25	115.67 units on a scale Standard Deviation 19.15

SECONDARY outcome

Timeframe: Within 6 months of randomization

Population: Intent-to-treat

Outcome measures

Outcome measures
Measure	Fecal Microbiota Therapy (FMT) n=76 Participants Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT	Placebo n=77 Participants Placebo Placebo: Oral capsule-delivered placebo
Frequency of Possible CDI Recurrences Within 6 Months of Randomization Have no possible CDI recurrence	45 Participants	48 Participants
Frequency of Possible CDI Recurrences Within 6 Months of Randomization Have one possible CDI recurrence	23 Participants	19 Participants
Frequency of Possible CDI Recurrences Within 6 Months of Randomization Have two possible CDI recurrences	7 Participants	9 Participants
Frequency of Possible CDI Recurrences Within 6 Months of Randomization Have three possible CDI recurrences	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Within 56 days of randomization

Population: intent-to-treat

This is similar to a possible recurrent CDI, but includes only episodes of diarrhea that are tested negative for C. difficile by EIA toxin test and PCR. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee.

Outcome measures

Outcome measures
Measure	Fecal Microbiota Therapy (FMT) n=76 Participants Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT	Placebo n=77 Participants Placebo Placebo: Oral capsule-delivered placebo
Diarrhea That is Negative for C. Difficile by EIA Toxin Test and Polymerase Chain Reaction (PCR)	9 Participants	8 Participants

SECONDARY outcome

Timeframe: Within 6 months of randomization

Population: intent-to-treat

Outcome measures

Outcome measures
Measure	Fecal Microbiota Therapy (FMT) n=40 Recurrences Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT	Placebo n=40 Recurrences Placebo Placebo: Oral capsule-delivered placebo
Occurrence of Abdominal Pain Among All Possible CDI Recurrences.	19 Recurrences	24 Recurrences

SECONDARY outcome

Timeframe: Within 56 days of randomization

Population: intent-to-treat

The occurrence of definite recurrent CDI within 56 days of randomization. A definite CDI recurrence is defined as a potential CDI recurrence with symptom (more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy) plus laboratory confirmation of C. difficile from a stool specimen by EIA toxin test.

Outcome measures

Outcome measures
Measure	Fecal Microbiota Therapy (FMT) n=76 Participants Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT	Placebo n=77 Participants Placebo Placebo: Oral capsule-delivered placebo
Definite Recurrent CDI	6 Participants	7 Participants

SECONDARY outcome

Timeframe: Within 56 days of randomization

Population: intent-to-treat

The occurrence of possible recurrent CDI within 56 days of randomization. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee.

Outcome measures

Outcome measures
Measure	Fecal Microbiota Therapy (FMT) n=76 Participants Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT	Placebo n=77 Participants Placebo Placebo: Oral capsule-delivered placebo
Possible Recurrent CDI	24 Participants	22 Participants

SECONDARY outcome

Timeframe: Within 56 days of randomization

Population: intent-to-treat

The occurrence of death within 56 days of randomization.

Outcome measures

Outcome measures
Measure	Fecal Microbiota Therapy (FMT) n=76 Participants Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT	Placebo n=77 Participants Placebo Placebo: Oral capsule-delivered placebo
Death	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Within 56 days of randomization

Population: intent-to-treat

This is similar to possible recurrent CDI, but includes only episodes of diarrhea that are tested negative for C. difficile by EIA toxin test but positive by PCR. A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee.

Outcome measures

Outcome measures
Measure	Fecal Microbiota Therapy (FMT) n=76 Participants Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT	Placebo n=77 Participants Placebo Placebo: Oral capsule-delivered placebo
Diarrhea That is Negative for C. Difficile by EIA Toxin Testing But Positive by PCR	6 Participants	6 Participants

SECONDARY outcome

Timeframe: within 6 months from randomization

Population: intent-to-treat

A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. Participants were asked to report whether they experienced urgency in each of their possible CDI recurrences. The urgency is defined as the urgent need to pass stool, feelings of incomplete bowel control, or inability to control defecation.

Outcome measures

Outcome measures
Measure	Fecal Microbiota Therapy (FMT) n=40 Recurrences Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT	Placebo n=40 Recurrences Placebo Placebo: Oral capsule-delivered placebo
Occurrence of Urgency Among All Possible CDI Recurrences.	36 Recurrences	36 Recurrences

SECONDARY outcome

Timeframe: within 6 months from randomization

Population: intent-to-treat

A possible CDI recurrence is defined as a new onset of more than three loose or watery stools in 24 hours for two consecutive days, not explained by another diagnosis, other clinical symptoms including ileus, toxic megacolon, or colectomy. As part of the protocol procedures, a possible CDI recurrence is adjudicated by the study's adjudication committee. Participants were asked to report whether they experienced fecal incontinence in each of their possible CDI recurrences. Fecal incontinence is defined as having unintentional passing of stool (liquid or solid).

Outcome measures

Outcome measures
Measure	Fecal Microbiota Therapy (FMT) n=40 Recurrences Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT	Placebo n=40 Recurrences Placebo Placebo: Oral capsule-delivered placebo
Occurrence of Fecal Incontinence Among All Possible CDI Recurrences.	21 Recurrences	18 Recurrences

SECONDARY outcome

Timeframe: within 6 months of randomization

Population: intent-to-treat

Outcome measures

Outcome measures
Measure	Fecal Microbiota Therapy (FMT) n=40 Recurrences Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT	Placebo n=40 Recurrences Placebo Placebo: Oral capsule-delivered placebo
Occurrence of Altering Life Style Among All Possible CDI Recurrences	30 Recurrences	25 Recurrences

Adverse Events

Fecal Microbiota Therapy (FMT)

Serious events: 17 serious events

Other events: 19 other events

Deaths: 1 deaths

Placebo

Serious events: 21 serious events

Other events: 28 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Additional Information

Yuan Huang, Ph.D., Biostatistician

VA Cooperative Studies Program

Phone: 2039325711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Fecal Microbiota Therapy (FMT) n=76 participants at risk Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT	Placebo n=77 participants at risk Placebo Placebo: Oral capsule-delivered placebo
Blood and lymphatic system disorders Immune thrombocytopenia	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Cardiac disorders cardiac failure	3.9% 3/76 • Number of events 4 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Cardiac disorders atrioventricular block	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Cardiac disorders cardiac arrest	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Gastrointestinal disorders diarrhoea	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Gastrointestinal disorders gastrointestinal vascular malformation haemorrhagic	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Gastrointestinal disorders abdominal pain	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Gastrointestinal disorders faecalomna	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Gastrointestinal disorders haematochezia	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Gastrointestinal disorders vomitting	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
General disorders stent-graft endoleak	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Hepatobiliary disorders colicholecystitis	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Hepatobiliary disorders cirrhosis alcoholic	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Immune system disorders solid organ transplant rejection	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Infections and infestations clostridium difficile infection	2.6% 2/76 • Number of events 2 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	7.8% 6/77 • Number of events 6 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Infections and infestations sepsis	2.6% 2/76 • Number of events 2 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Infections and infestations urinary tract infection	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	2.6% 2/77 • Number of events 2 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Infections and infestations cellulitis	2.6% 2/76 • Number of events 2 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Infections and infestations COVID-19 pneumonia	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Infections and infestations gastroenteritis viral	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Infections and infestations meningitis viral	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Infections and infestations peritonitis bacterial	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Infections and infestations urosepsis	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Investigations colonoscopy	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Neoplasms benign, malignant and unspecified (incl cysts and polyps) metastases to spine	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Neoplasms benign, malignant and unspecified (incl cysts and polyps) renal cancer	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Neoplasms benign, malignant and unspecified (incl cysts and polyps) diffuse large B-cell lymphoma	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Neoplasms benign, malignant and unspecified (incl cysts and polyps) plasma cell myeloma	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Nervous system disorders cerebral haemorrhage	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Psychiatric disorders post-traumatic stress disorder	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Psychiatric disorders major depression	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Renal and urinary disorders nephrolithiasis	2.6% 2/76 • Number of events 2 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Renal and urinary disorders nephrotic syndrome	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 2 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Respiratory, thoracic and mediastinal disorders chronic obstructive pulmonary disease	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	2.6% 2/77 • Number of events 2 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Respiratory, thoracic and mediastinal disorders pulmonary embolism	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Respiratory, thoracic and mediastinal disorders respiratory distress	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Vascular disorders hypertensive emergency	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Vascular disorders peripheral vein occlusion	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov

Other adverse events
Measure	Fecal Microbiota Therapy (FMT) n=76 participants at risk Fecal Microbiota Therapy (FMT) Fecal Microbiota Therapy (FMT): Oral capsule-delivered FMT	Placebo n=77 participants at risk Placebo Placebo: Oral capsule-delivered placebo
Gastrointestinal disorders constipation	3.9% 3/76 • Number of events 3 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	3.9% 3/77 • Number of events 3 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Gastrointestinal disorders diarrhoea	2.6% 2/76 • Number of events 2 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	2.6% 2/77 • Number of events 3 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Gastrointestinal disorders abdominal pain	2.6% 2/76 • Number of events 2 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	2.6% 2/77 • Number of events 2 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Gastrointestinal disorders Nausea	5.3% 4/76 • Number of events 4 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	5.2% 4/77 • Number of events 4 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Gastrointestinal disorders Dafaecation urgency	3.9% 3/76 • Number of events 3 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	5.2% 4/77 • Number of events 4 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Gastrointestinal disorders Flatulence	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	6.5% 5/77 • Number of events 6 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Gastrointestinal disorders vomiting	2.6% 2/76 • Number of events 2 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	2.6% 2/77 • Number of events 2 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Gastrointestinal disorders abdominal distension	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	3.9% 3/77 • Number of events 3 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Gastrointestinal disorders gastrointestinal hypermotility	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Gastrointestinal disorders anorectal discomfort	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Gastrointestinal disorders Eructation	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Gastrointestinal disorders gastroesophageal reflux disease	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Gastrointestinal disorders haematochezia	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
General disorders fatigua	2.6% 2/76 • Number of events 2 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
General disorders pyrexia	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Infections and infestations Urinary tract infection	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Infections and infestations COVID-19	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Infections and infestations rectal abscess	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Infections and infestations gastritis viral	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Infections and infestations gastroenteritis	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Infections and infestations nasopharygnigitis	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Injury, poisoning and procedural complications tooth fracture	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Investigations renal function test abnormal	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Investigations white blood cell count increased	1.3% 1/76 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	0.00% 0/77 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Investigations stool analysis abnormal	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Investigations urine output increased	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Metabolism and nutrition disorders decreased appetite	2.6% 2/76 • Number of events 2 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Musculoskeletal and connective tissue disorders arthralgia	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Nervous system disorders dizziness	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Nervous system disorders taste disorder	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Renal and urinary disorders haematuria	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Respiratory, thoracic and mediastinal disorders dyspnoea	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov
Vascular disorders hypertension	0.00% 0/76 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov	1.3% 1/77 • Number of events 1 • All participants will be monitored for adverse events from the time of randomization/ administration of study medication to the study exit time (typically at 6 months after study treatment). The study definition is consistent with those definitions in ClinicalTrials.gov