Trial Outcomes & Findings for Safety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS) (NCT NCT02160782)

Last Updated: 2021-07-14

Results Overview

The primary efficacy endpoint of this study was the mean change from Week 18 to Week 22 (the RWD period) of fasting sBA levels in participants who had a reduction in sBA ≥50% from baseline to Week 12 or Week 18 (Modified Intent-to-Treat \[MITT\] Population). Five participants in the MRX group and 10 participants in the placebo group met the prespecified sBA reduction criteria.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

Week 18 to Week 22

Results posted on

2021-07-14

Participant Flow

The participants were enrolled at 9 sites in 6 countries (Australia, UK, France, Poland, Spain and Belgium) between 28 October 2014 and 11 September 2015

A total of 36 patients were screened for the study. 31 patients were enrolled, while 5 patients were screen failures.

Participant milestones

Participant milestones
Measure	Open-label Period: Maralixibat (LUM001) All participants received Maralixibat (LUM001:MRX) at doses of up to 400 μg/kg once daily (QD) during a 6-week open-label dose-escalation period, followed by a 12-week open-label stable-dosing period. All participants reached 400 μg/kg QD for this period. Participants were randomized 1:1 to continue to receive MRX or placebo (Pbo) for 4 weeks between the start of Week 19 and the end of Week 22 (the double-blind, placebo-controlled study drug withdrawal period). All participants, caregivers, monitors, and study center personnel related to the study, except for the central pharmacist who prepared the study drug, were blinded to the participants' study drug withdrawal period treatment assignment during the randomized withdrawal (RWD) period. Participants who received placebo during the RWD period returned to MRX 400 μg/kg QD in a 26-week long-term exposure period to complete 48 weeks of treatment. Participants who received MRX during the RWD period continued in a 26-week long-term exposure period to complete 48 weeks of treatment.	Randomized Withdrawal Period: MRX Participants continued to receive MRX at 400 μg/kg QD during the RWD period	Randomized Withdrawal Period: Placebo Participants received a corresponding placebo during the RWD period	After Randomized Withdrawal Period: Maralixibat Participants who received placebo during the RWD period returned to the MRX 400 μg/kg QD in a 26-week long-term exposure period to complete 48 weeks of treatment. Participants who received MRX during the RWD period continued in a 26-week long-term exposure period to complete 48 weeks of treatment. Participants remained blinded to their assigned arm during the RWD period.	Long-term Extension Period: Maralixibat The long-term extension (LTE) period consisted of 2 phases: (1) a 52-week optional follow-up treatment period (Weeks 49-100), during which participants received up to 400 μg/kg QD MRX. This was followed by: (2) a long-term optional follow-up treatment period (\>Week 100) during which participants received up to 400 μg/kg BID doses of MRX.
Open-label Period: Maralixibat STARTED	31	0	0	0	0
Open-label Period: Maralixibat COMPLETED	29	0	0	0	0
Open-label Period: Maralixibat NOT COMPLETED	2	0	0	0	0
Randomized Withdrawal Period- Pbo vs MRX STARTED	0	13	16	0	0
Randomized Withdrawal Period- Pbo vs MRX COMPLETED	0	13	16	0	0
Randomized Withdrawal Period- Pbo vs MRX NOT COMPLETED	0	0	0	0	0
After Randomized Withdrawal: Maralixibat STARTED	0	0	0	29	0
After Randomized Withdrawal: Maralixibat COMPLETED	0	0	0	23	0
After Randomized Withdrawal: Maralixibat NOT COMPLETED	0	0	0	6	0
Long-term Extension Period: Maralixibat STARTED	0	0	0	0	23
Long-term Extension Period: Maralixibat COMPLETED	0	0	0	0	14
Long-term Extension Period: Maralixibat NOT COMPLETED	0	0	0	0	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Open-label Period: Maralixibat (LUM001) All participants received Maralixibat (LUM001:MRX) at doses of up to 400 μg/kg once daily (QD) during a 6-week open-label dose-escalation period, followed by a 12-week open-label stable-dosing period. All participants reached 400 μg/kg QD for this period. Participants were randomized 1:1 to continue to receive MRX or placebo (Pbo) for 4 weeks between the start of Week 19 and the end of Week 22 (the double-blind, placebo-controlled study drug withdrawal period). All participants, caregivers, monitors, and study center personnel related to the study, except for the central pharmacist who prepared the study drug, were blinded to the participants' study drug withdrawal period treatment assignment during the randomized withdrawal (RWD) period. Participants who received placebo during the RWD period returned to MRX 400 μg/kg QD in a 26-week long-term exposure period to complete 48 weeks of treatment. Participants who received MRX during the RWD period continued in a 26-week long-term exposure period to complete 48 weeks of treatment.	After Randomized Withdrawal Period: Maralixibat Participants who received placebo during the RWD period returned to the MRX 400 μg/kg QD in a 26-week long-term exposure period to complete 48 weeks of treatment. Participants who received MRX during the RWD period continued in a 26-week long-term exposure period to complete 48 weeks of treatment. Participants remained blinded to their assigned arm during the RWD period.	Long-term Extension Period: Maralixibat The long-term extension (LTE) period consisted of 2 phases: (1) a 52-week optional follow-up treatment period (Weeks 49-100), during which participants received up to 400 μg/kg QD MRX. This was followed by: (2) a long-term optional follow-up treatment period (\>Week 100) during which participants received up to 400 μg/kg BID doses of MRX.
Open-label Period: Maralixibat Adverse Event	2	0	0
After Randomized Withdrawal: Maralixibat Adverse Event	0	1	0
After Randomized Withdrawal: Maralixibat Did not consent to protocol amendment for long term extension	0	5	0
Long-term Extension Period: Maralixibat Did not consent to protocol amendment	0	0	4
Long-term Extension Period: Maralixibat Physician Decision	0	0	1
Long-term Extension Period: Maralixibat Adverse Event	0	0	3
Long-term Extension Period: Maralixibat Withdrawal by caregiver	0	0	1

Baseline Characteristics

Safety and Efficacy Study of LUM001 (Maralixibat) With a Drug Withdrawal Period in Participants With Alagille Syndrome (ALGS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open-label Period: Maralixibat n=31 Participants All participants received MRX at doses of up to 400 μg/kg once daily (QD) during a 6-week open-label dose-escalation period, followed by a 12-week open-label stable-dosing period. All participants reached 400 μg/kg QD for this period.
Age, Continuous	5.4 years of age STANDARD_DEVIATION 4.25 • n=5 Participants
Age, Customized <2 years	6 Participants n=5 Participants
Age, Customized 2 to 4 years	9 Participants n=5 Participants
Age, Customized 5 to 8 years	9 Participants n=5 Participants
Age, Customized 9 to 12 years	4 Participants n=5 Participants
Age, Customized 13 to 18 years	3 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	NA Participants n=5 Participants
Race (NIH/OMB) Asian	NA Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	NA Participants n=5 Participants
Race (NIH/OMB) Black or African American	NA Participants n=5 Participants
Race (NIH/OMB) White	NA Participants n=5 Participants
Race (NIH/OMB) More than one race	NA Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	NA Participants n=5 Participants
Region of Enrollment Australia	9 participants n=5 Participants
Region of Enrollment Belgium	5 participants n=5 Participants
Region of Enrollment France	9 participants n=5 Participants
Region of Enrollment Poland	3 participants n=5 Participants
Region of Enrollment Spain	2 participants n=5 Participants
Region of Enrollment United Kingdom	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 18 to Week 22

Population: Primary outcome used the (Modified Intent-to-Treat \[MITT\]Population. The MITT population is defined as participants who had a reduction in sBA ≥50% from baseline to Week 12 or Week 18. Five participants in the MRX group and 10 participants in the placebo group met the prespecified sBA reduction criteria.

Outcome measures

Outcome measures
Measure	Randomized Withdrawal Period: MRX n=5 Participants Participants continued to receive MRX at 400 μg/kg QD during the RWD period	Randomized Withdrawal Period: Placebo n=10 Participants Participants received a corresponding placebo during the RWD period
Change From Week 18 to Week 22 in Fasting sBA Levels in Participants Who Had a Reduction in sBA ≥50% From Baseline to Week 12 or Week 18	-21.73 μmol/L Standard Error 43.125	95.55 μmol/L Standard Error 30.488

SECONDARY outcome

Timeframe: Baseline to Week 18

Population: Values were collected from 31 participants at baseline. Values were collected at Week 18 from 29 of the 31 participants who contributed values at baseline.

This secondary efficacy endpoint is the mean change from baseline to Week 18 in fasting sBA levels

Outcome measures

Outcome measures
Measure	Randomized Withdrawal Period: MRX n=31 Participants Participants continued to receive MRX at 400 μg/kg QD during the RWD period	Randomized Withdrawal Period: Placebo n=29 Participants Participants received a corresponding placebo during the RWD period
Change From Baseline to Week 18 in Fasting sBA Levels	283.43 μmol/L Standard Deviation 210.569	192.50 μmol/L Standard Deviation 161.278

SECONDARY outcome

Timeframe: Baseline to Week 18

Population: Values were collected from 31 participants at baseline. Values were collected at Week 18 from 29 of the 31 participants who contributed values at baseline.

This secondary efficacy endpoint is the change from baseline to Week 18 in pruritus as measured by ItchRO(Obs) weekly average morning score. ItchRO scores range from 0 to 4; the higher score indicates increasing itch severity (0 = none; 4 = very severe).

Outcome measures

Outcome measures
Measure	Randomized Withdrawal Period: MRX n=31 Participants Participants continued to receive MRX at 400 μg/kg QD during the RWD period	Randomized Withdrawal Period: Placebo n=29 Participants Participants received a corresponding placebo during the RWD period
Change From Baseline to Week 18 in Pruritus as Measured by ItchRO (Obs)	2.909 Points Standard Deviation 0.5480	1.203 Points Standard Deviation 0.8446

SECONDARY outcome

Timeframe: Baseline to Week 18

Population: NOTE: 2 participants discontinued prior week 18 and did not provide data.

This secondary efficacy endpoint is the change from baseline to Week 18 in pruritus as measured by ItchRO(Pt) weekly average morning score

Outcome measures

Outcome measures
Measure	Randomized Withdrawal Period: MRX n=31 Participants Participants continued to receive MRX at 400 μg/kg QD during the RWD period	Randomized Withdrawal Period: Placebo n=29 Participants Participants received a corresponding placebo during the RWD period
Change From Baseline to Week 18 in Pruritus as Measured by ItchRO (Pt)	2.903 Points Standard Deviation 0.6616	0.831 Points Standard Deviation 0.8122

SECONDARY outcome

Timeframe: Week 18 to Week 22

Population: For Maralixibat, n=12 for ItchRO(Obs) weekly average morning score For Placebo, n=16 for ItchRO(Obs) weekly average morning score

This secondary efficacy endpoint is the change from Week 18 to Week 22 in pruritus as measured by ItchRO(Obs) weekly average morning score. ItchRO scores range from 0 to 4; the higher score indicates increasing itch severity (0 = none; 4 = very severe).

Outcome measures

Outcome measures
Measure	Randomized Withdrawal Period: MRX n=12 Participants Participants continued to receive MRX at 400 μg/kg QD during the RWD period	Randomized Withdrawal Period: Placebo n=16 Participants Participants received a corresponding placebo during the RWD period
Change From Week 18 to Week 22 in Pruritus as Measured by ItchRO(Obs)	0.217 Points Standard Error 0.2345	1.700 Points Standard Error 0.2031

SECONDARY outcome

Timeframe: Week 18 to Week 22

Population: ItchRO(Pt) was completed independently in participants 9 years old or older. Children between the ages of 5 and 8 years old completed the patient instrument with the assistance of their caregiver, if needed.

This secondary efficacy endpoint is the change from Week 18 to Week 22 in pruritus as measured by ItchRO(Pt) weekly average morning score. ItchRO scores range from 0 to 4; the higher score indicates increasing itch severity (0 = none; 4 = very severe).

Outcome measures

Outcome measures
Measure	Randomized Withdrawal Period: MRX n=5 Participants Participants continued to receive MRX at 400 μg/kg QD during the RWD period	Randomized Withdrawal Period: Placebo n=9 Participants Participants received a corresponding placebo during the RWD period
Change From Week 18 to Week 22 in Pruritus as Measured by ItchRO(Pt)	-0.149 Points Standard Error 0.3719	1.839 Points Standard Error 0.2771

SECONDARY outcome

Timeframe: Baseline to Week 18

Population: Values were collected from 31 participants at baseline. Values were collected at Week 18 from 29 of the 31 participants who contributed values at baseline.

This secondary efficacy endpoint is the mean change from baseline to Week 18 in ALP

Outcome measures

Outcome measures
Measure	Randomized Withdrawal Period: MRX n=31 Participants Participants continued to receive MRX at 400 μg/kg QD during the RWD period	Randomized Withdrawal Period: Placebo n=29 Participants Participants received a corresponding placebo during the RWD period
Change From Baseline to Week 18 in Alkaline Phosphatase	601.3 U/L Standard Deviation 274.77	580.8 U/L Standard Deviation 215.50

SECONDARY outcome

Timeframe: Week 18 to Week 22

This secondary efficacy endpoint is the mean change from Week 18 to Week 22 in ALP

Outcome measures

Outcome measures
Measure	Randomized Withdrawal Period: MRX n=13 Participants Participants continued to receive MRX at 400 μg/kg QD during the RWD period	Randomized Withdrawal Period: Placebo n=16 Participants Participants received a corresponding placebo during the RWD period
Change From Week 18 to Week 22 in Alkaline Phosphatase	2.8 U/L Standard Error 22.55	-7.2 U/L Standard Error 20.31

SECONDARY outcome

Timeframe: Baseline to Week 18

Population: Values were collected from 31 participants at baseline. Values were collected at Week 18 from 29 of the 31 participants who contributed values at baseline.

This secondary efficacy endpoint is the mean change from baseline to Week 18 in ALT

Outcome measures

Outcome measures
Measure	Randomized Withdrawal Period: MRX n=31 Participants Participants continued to receive MRX at 400 μg/kg QD during the RWD period	Randomized Withdrawal Period: Placebo n=29 Participants Participants received a corresponding placebo during the RWD period
Change From Baseline to Week 18 in Alanine Aminotransferase	181.0 U/L Standard Deviation 108.56	177.4 U/L Standard Deviation 92.08

SECONDARY outcome

Timeframe: Week 18 to Week 22

Population: The difference between treatment groups in change from Week 18 to Week 22 in ALT levels was evaluated using an ANCOVA model with treatment group as a factor, and Week 18 ALT as a covariate. The analysis used a tabulation of fitted summary statistics from ANCOVA in the intent-to-treat population, which included all participants who were enrolled, and received at least one dose of study drug.

This secondary efficacy endpoint is the mean change from Week 18 to Week 22 in alanine aminotransferase (ALT)

Outcome measures

Outcome measures
Measure	Randomized Withdrawal Period: MRX n=13 Participants Participants continued to receive MRX at 400 μg/kg QD during the RWD period	Randomized Withdrawal Period: Placebo n=16 Participants Participants received a corresponding placebo during the RWD period
Change From Week 18 to Week 22 in Alanine Aminotransferase	34.5 U/L Standard Error 14.04	19.4 U/L Standard Error 12.56

SECONDARY outcome

Timeframe: Baseline to Week 18

Population: Open-label period: MRX baseline v Open-label period: MRX Week 18

This secondary efficacy endpoint is the mean change from baseline to Week 18 in total bilirubin

Outcome measures

Outcome measures
Measure	Randomized Withdrawal Period: MRX n=31 Participants Participants continued to receive MRX at 400 μg/kg QD during the RWD period	Randomized Withdrawal Period: Placebo n=29 Participants Participants received a corresponding placebo during the RWD period
Change From Baseline to Week 18 in Total Bilirubin	6.09 mg/dL Standard Deviation 5.781	5.12 mg/dL Standard Deviation 5.337

SECONDARY outcome

Timeframe: Week 18 to Week 22

This secondary efficacy endpoint is the mean change from Week 18 to Week 22 in total bilirubin

Outcome measures

Outcome measures
Measure	Randomized Withdrawal Period: MRX n=13 Participants Participants continued to receive MRX at 400 μg/kg QD during the RWD period	Randomized Withdrawal Period: Placebo n=16 Participants Participants received a corresponding placebo during the RWD period
Change From Week 18 to Week 22 in Total Bilirubin	0.32 mg/dL Standard Error 0.265	0.46 mg/dL Standard Error 0.238

SECONDARY outcome

Timeframe: Baseline to Week 18

Population: Values from the open-label period were collected from 31 participants at baseline. Values were collected at Week 18 from 28 of the 31 participants who contributed values at baseline.

This secondary efficacy endpoint is the mean change from baseline to Week 18 in direct bilirubin

Outcome measures

Outcome measures
Measure	Randomized Withdrawal Period: MRX n=31 Participants Participants continued to receive MRX at 400 μg/kg QD during the RWD period	Randomized Withdrawal Period: Placebo n=28 Participants Participants received a corresponding placebo during the RWD period
Change From Baseline to Week 18 in Direct Bilirubin	4.57 mg/dL Standard Deviation 3.666	3.98 mg/dL Standard Deviation 3.369

SECONDARY outcome

Timeframe: Week 18 to Week 22

This secondary efficacy endpoint is the mean change from Week 18 to Week 22 in direct bilirubin

Outcome measures

Outcome measures
Measure	Randomized Withdrawal Period: MRX n=12 Participants Participants continued to receive MRX at 400 μg/kg QD during the RWD period	Randomized Withdrawal Period: Placebo n=15 Participants Participants received a corresponding placebo during the RWD period
Change From Week 18 to Week 22 in Direct Bilirubin	0.13 mg/dL Standard Error 0.195	0.14 mg/dL Standard Error 0.174

Adverse Events

Open-label Period: Maralixibat (LUM001)

Serious events: 4 serious events

Other events: 29 other events

Deaths: 0 deaths

Randomized Withdrawal Period: MRX

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Randomized Withdrawal Period: Placebo

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

After Randomized Withdrawal Period: Maralixibat

Serious events: 5 serious events

Other events: 25 other events

Deaths: 0 deaths

Long-term Extension Period: Maralixibat

Serious events: 6 serious events

Other events: 23 other events

Deaths: 0 deaths

Safety Population

Serious events: 13 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Open-label Period: Maralixibat (LUM001) n=31 participants at risk All participants received MRX at doses of up to 400 μg/kg once daily (QD) during a 6-week open-label dose-escalation period, followed by a 12-week open-label stable-dosing period. All participants reached 400 μg/kg QD for this period.	Randomized Withdrawal Period: MRX n=13 participants at risk Participants continued to receive MRX at 400 μg/kg QD during the RWD period	Randomized Withdrawal Period: Placebo n=16 participants at risk Participants received a corresponding placebo during the RWD period	After Randomized Withdrawal Period: Maralixibat n=29 participants at risk Participants who received placebo during the RWD period returned to the MRX 400 μg/kg QD in a 26-week long-term exposure period to complete 48 weeks of treatment. Participants who received MRX during the RWD period continued in a 26-week long-term exposure period to complete 48 weeks of treatment. Participants remained blinded to their assigned arm during the RWD period.	Long-term Extension Period: Maralixibat n=23 participants at risk The long-term extension (LTE) period consisted of 2 phases: (1) a 52-week optional follow-up treatment period (Weeks 49-100), during which participants received up to 400 μg/kg QD MRX. This was followed by: (2) a long-term optional follow-up treatment period (\>Week 100) during which participants received up to 400 μg/kg BID doses of MRX.	Safety Population n=31 participants at risk The safety population was defined as all participants who were assigned and received at least one dose of the study drug.
Injury, poisoning and procedural complications Extradural haematoma	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Vascular disorders Hypertension	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Vascular disorders Shock haemorrhagic	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.2% 1/16 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.2% 1/16 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Splenic rupture	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.2% 1/16 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Subdural haemorrhage	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Investigations Blood bilirubin increased	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Marrow hyperplasia	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Cardiac disorders Cardiac dysfunction	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Blood and lymphatic system disorders Aplasia pure red cell	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Nervous system disorders Seizure	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
General disorders Chest pain	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.2% 1/16 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
General disorders Influenza like illness	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
General disorders Pyrexia	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.2% 1/16 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Abdominal pain	3.2% 1/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Diarrhoea	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Vomiting	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Renal and urinary disorders Acute kidney injury	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Epstein-Barr virus infection	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Gastroenteritis	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Rotavirus infection	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Tonsillitis	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Viral infection	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	7.7% 1/13 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Viral pharyngitis	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.

Other adverse events

Other adverse events
Measure	Open-label Period: Maralixibat (LUM001) n=31 participants at risk All participants received MRX at doses of up to 400 μg/kg once daily (QD) during a 6-week open-label dose-escalation period, followed by a 12-week open-label stable-dosing period. All participants reached 400 μg/kg QD for this period.	Randomized Withdrawal Period: MRX n=13 participants at risk Participants continued to receive MRX at 400 μg/kg QD during the RWD period	Randomized Withdrawal Period: Placebo n=16 participants at risk Participants received a corresponding placebo during the RWD period	After Randomized Withdrawal Period: Maralixibat n=29 participants at risk Participants who received placebo during the RWD period returned to the MRX 400 μg/kg QD in a 26-week long-term exposure period to complete 48 weeks of treatment. Participants who received MRX during the RWD period continued in a 26-week long-term exposure period to complete 48 weeks of treatment. Participants remained blinded to their assigned arm during the RWD period.	Long-term Extension Period: Maralixibat n=23 participants at risk The long-term extension (LTE) period consisted of 2 phases: (1) a 52-week optional follow-up treatment period (Weeks 49-100), during which participants received up to 400 μg/kg QD MRX. This was followed by: (2) a long-term optional follow-up treatment period (\>Week 100) during which participants received up to 400 μg/kg BID doses of MRX.	Safety Population n=31 participants at risk The safety population was defined as all participants who were assigned and received at least one dose of the study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	12.9% 4/31 • Number of events 4 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.2% 1/31 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	8.7% 2/23 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 5 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	10.3% 3/29 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	13.0% 3/23 • Number of events 5 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	22.6% 7/31 • Number of events 9 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Vascular disorders Hypertension	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.2% 1/16 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Vascular disorders Subclavian artery stenosis	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Surgical and medical procedures Gastrostomy	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm skin	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Immune system disorders Allergy to animal	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Immune system disorders Seasonal allergy	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
General disorders Chest pain	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
General disorders Condition aggravated	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.2% 1/16 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
General disorders Face oedema	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
General disorders Fatigue	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	9.7% 3/31 • Number of events 4 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
General disorders Influenza like illness	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.9% 2/29 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	8.7% 2/23 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	9.7% 3/31 • Number of events 4 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
General disorders Pyrexia	19.4% 6/31 • Number of events 12 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.2% 1/16 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	24.1% 7/29 • Number of events 12 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	43.5% 10/23 • Number of events 27 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	54.8% 17/31 • Number of events 52 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Psychiatric disorders Breath holding	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Psychiatric disorders Enuresis	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Psychiatric disorders Hallucination, visual	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Psychiatric disorders Insomnia	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	8.7% 2/23 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Psychiatric disorders Intentional self-injury	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Psychiatric disorders Psychological trauma	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.2% 1/16 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Bite	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Contusion	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	13.0% 3/23 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	12.9% 4/31 • Number of events 4 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Face injury	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Fall	12.9% 4/31 • Number of events 7 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	10.3% 3/29 • Number of events 5 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	19.4% 6/31 • Number of events 12 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Head injury	6.5% 2/31 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	9.7% 3/31 • Number of events 5 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Limb injury	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Lip injury	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Muscle strain	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	8.7% 2/23 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	9.7% 3/31 • Number of events 4 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Nasal injury	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.9% 2/29 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	9.7% 3/31 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Overdose	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	8.7% 2/23 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Skin abrasion	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 5 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	9.7% 3/31 • Number of events 8 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Skin laceration	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.9% 2/29 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	9.7% 3/31 • Number of events 5 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Tooth avulsion	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Injury, poisoning and procedural complications Vaccination complication	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Investigations Alanine aminotransferase increased	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	17.4% 4/23 • Number of events 5 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	12.9% 4/31 • Number of events 5 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Investigations Aspartate aminotransferase increased	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	8.7% 2/23 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Investigations International normalised ratio increased	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Investigations Vitamin A increased	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Investigations Vitamin D decreased	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Investigations Weight decreased	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Cardiac disorders Bradycardia	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Congenital, familial and genetic disorders Phimosis	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	8.7% 2/23 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Respiratory, thoracic and mediastinal disorders Asthma	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Respiratory, thoracic and mediastinal disorders Cough	9.7% 3/31 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	10.3% 3/29 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	34.8% 8/23 • Number of events 12 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	41.9% 13/31 • Number of events 18 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Blood and lymphatic system disorders Anaemia	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Blood and lymphatic system disorders Coagulopathy	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Nervous system disorders Arachnoid cyst	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Nervous system disorders Headache	16.1% 5/31 • Number of events 5 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.9% 2/29 • Number of events 4 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	17.4% 4/23 • Number of events 10 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	29.0% 9/31 • Number of events 19 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Nervous system disorders Hyperaesthesia	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Nervous system disorders Lethargy	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Nervous system disorders Poor quality sleep	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.2% 1/16 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Eye disorders Hypermetropia	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Eye disorders Visual acuity reduced	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Ear and labyrinth disorders Conductive deafness	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Ear and labyrinth disorders Deafness neurosensory	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Ear and labyrinth disorders Ear pain	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	10.3% 3/29 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	9.7% 3/31 • Number of events 6 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Ear and labyrinth disorders Excessive cerumen production	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Ear and labyrinth disorders Middle ear effusion	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Abdominal discomfort	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Abdominal pain	38.7% 12/31 • Number of events 22 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	7.7% 1/13 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.2% 1/16 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	20.7% 6/29 • Number of events 12 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	52.2% 12/23 • Number of events 31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	58.1% 18/31 • Number of events 67 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Abdominal pain upper	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Constipation	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	9.7% 3/31 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Dental caries	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	8.7% 2/23 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Diarrhoea	41.9% 13/31 • Number of events 18 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	7.7% 1/13 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.2% 1/16 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	17.2% 5/29 • Number of events 10 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	30.4% 7/23 • Number of events 18 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	58.1% 18/31 • Number of events 48 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Faeces pale	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	8.7% 2/23 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	9.7% 3/31 • Number of events 5 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Gastritis	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	8.7% 2/23 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	9.7% 3/31 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Haematochezia	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Lip discolouration	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Lip swelling	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Mouth ulceration	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Nausea	3.2% 1/31 • Number of events 4 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	7.7% 1/13 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	8.7% 2/23 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 8 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Proctalgia	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Tongue discolouration	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Toothache	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Gastrointestinal disorders Vomiting	35.5% 11/31 • Number of events 15 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	7.7% 1/13 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.2% 1/16 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.9% 2/29 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	34.8% 8/23 • Number of events 13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	51.6% 16/31 • Number of events 34 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Renal and urinary disorders Chromaturia	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.2% 1/16 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Renal and urinary disorders Dysuria	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Renal and urinary disorders Glomerulonephropathy	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Renal and urinary disorders Renal tubular acidosis	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.2% 1/16 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Hepatobiliary disorders Hepatomegaly	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Hepatobiliary disorders Jaundice	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Skin and subcutaneous tissue disorders Alopecia	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	7.7% 1/13 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Skin and subcutaneous tissue disorders Pruritus	9.7% 3/31 • Number of events 4 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	7.7% 1/13 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	31.2% 5/16 • Number of events 5 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.9% 2/29 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	29.0% 9/31 • Number of events 13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Skin and subcutaneous tissue disorders Rash	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Musculoskeletal and connective tissue disorders Arthralgia	3.2% 1/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 5 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Musculoskeletal and connective tissue disorders Bone cyst	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Musculoskeletal and connective tissue disorders Growth retardation	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Musculoskeletal and connective tissue disorders Ligamentitis	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	17.4% 4/23 • Number of events 5 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	12.9% 4/31 • Number of events 5 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Metabolism and nutrition disorders Decreased appetite	6.5% 2/31 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Metabolism and nutrition disorders Dehydration	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	7.7% 1/13 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Metabolism and nutrition disorders Malnutrition	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Metabolism and nutrition disorders Vitamin A deficiency	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Metabolism and nutrition disorders Vitamin C deficiency	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Metabolism and nutrition disorders Weight gain poor	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Abscess	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Bronchitis	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	8.7% 2/23 • Number of events 6 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	9.7% 3/31 • Number of events 7 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Croup infectious	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Dermatitis infected	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Ear infection	9.7% 3/31 • Number of events 4 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	13.8% 4/29 • Number of events 4 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	21.7% 5/23 • Number of events 6 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	25.8% 8/31 • Number of events 14 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Epstein-Barr virus infection	3.2% 1/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Fungal skin infection	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Gastritis viral	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Gastroenteritis	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.2% 1/16 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	21.7% 5/23 • Number of events 7 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	22.6% 7/31 • Number of events 9 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Infected bite	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Influenza	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	7.7% 1/13 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	8.7% 2/23 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	16.1% 5/31 • Number of events 6 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Laryngitis	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Localised infection	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Lower respiratory tract infection	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	8.7% 2/23 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Molluscum contagiosum	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Nasopharyngitis	12.9% 4/31 • Number of events 4 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	7.7% 1/13 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.2% 1/16 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	27.6% 8/29 • Number of events 21 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	39.1% 9/23 • Number of events 46 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	41.9% 13/31 • Number of events 73 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Oral herpes	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Otitis media	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	8.7% 2/23 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	12.9% 4/31 • Number of events 4 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Otitis media acute	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Pharyngitis	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.2% 1/16 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	13.0% 3/23 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	12.9% 4/31 • Number of events 4 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Pharyngotonsillitis	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Pneumonia	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Respiratory tract infection	3.2% 1/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.2% 1/16 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Rhinitis	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	7.7% 1/13 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	9.7% 3/31 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Rotavirus infection	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Sinusitis	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Skin infection	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Staphylococcal infection	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Tonsillitis	0.00% 0/31 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	4.3% 1/23 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	6.5% 2/31 • Number of events 2 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Upper respiratory tract infection	19.4% 6/31 • Number of events 6 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	15.4% 2/13 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	10.3% 3/29 • Number of events 3 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	17.4% 4/23 • Number of events 6 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	29.0% 9/31 • Number of events 28 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Urinary tract infection	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Varicella	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/13 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/29 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/23 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.
Infections and infestations Viral infection	3.2% 1/31 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	7.7% 1/13 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	0.00% 0/16 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	3.4% 1/29 • Number of events 1 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	21.7% 5/23 • Number of events 5 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.	25.8% 8/31 • Number of events 8 • Baseline to study completion (median of 2 years) All treatment-emergent AEs, whether observed by the Investigator, reported by the participant, the participant's caregiver, from laboratory findings, or other means, were recorded on the AE eCRF and medical record. 'Occurrences' relates to the number of events; 'subjects affected' relates to the number of participants who experienced the AE.

Additional Information

Mirum Clinical Trials

Mirum Pharmaceuticals

Phone: 1 650-667-4085

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place