Trial Outcomes & Findings for Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3) (NCT NCT05764239)

Last Updated: 2024-06-20

Results Overview

Baseline for blood Phe level in the DEP was defined as the mean of the duplicate blood Phe level measurements obtained immediately prior to administration of the first dose in the DEP. If only 1 blood Phe level measurement was available, then that measure was used as baseline. The last measurement was the participant's last Week 3 blood Phe level at the iTD of SYNB1934v1.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

35 participants

Primary outcome timeframe

Up to 15 weeks

Results posted on

2024-06-20

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants In the DEP (Part 1), participants received SYNB1934v1 on the following dose-ramp regimen: Dose level 1 (Days 1-9): 3 × 10\^11 live cells partial dose up to TID; Dose level 2 (Weeks 4-6): 6 × 10\^11 live cells up to TID; Dose level 3 (Weeks 7-9): 1 × 10\^12 live cells up to TID. In the RWP (Part 2), participants who completed the DEP were randomized 1:1 to receive SYNB1934v1 at their iTD established in the DEP (no modifications permitted). In the OLE (Part 3), participants completed a dose ramp to their iTD guided by tolerability, as described for the DEP, including the full dose-ramp schedule; the OLE iTD may have been different from the DEP/RWP iTD. SYNB1934v1 and placebo (color matched) consisted of powder for oral suspension packaged in sachets and resuspended in water or apple juice. Investigational medical product (IMP, ie, SYNB1934v1 or placebo) was administered orally immediately after meals.
DEP (Part 1) STARTED	35
DEP (Part 1) Completed DEP	17
DEP (Part 1) COMPLETED	0
DEP (Part 1) NOT COMPLETED	35
RWP (Part 2, SYNB1934v1) STARTED	9
RWP (Part 2, SYNB1934v1) Completed RWP	9
RWP (Part 2, SYNB1934v1) COMPLETED	0
RWP (Part 2, SYNB1934v1) NOT COMPLETED	9
RWP (Part 2, Placebo) STARTED	8
RWP (Part 2, Placebo) Completed RWP	8
RWP (Part 2, Placebo) COMPLETED	0
RWP (Part 2, Placebo) NOT COMPLETED	8
OLE (Part 3) STARTED	10
OLE (Part 3) COMPLETED	0
OLE (Part 3) NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants In the DEP (Part 1), participants received SYNB1934v1 on the following dose-ramp regimen: Dose level 1 (Days 1-9): 3 × 10\^11 live cells partial dose up to TID; Dose level 2 (Weeks 4-6): 6 × 10\^11 live cells up to TID; Dose level 3 (Weeks 7-9): 1 × 10\^12 live cells up to TID. In the RWP (Part 2), participants who completed the DEP were randomized 1:1 to receive SYNB1934v1 at their iTD established in the DEP (no modifications permitted). In the OLE (Part 3), participants completed a dose ramp to their iTD guided by tolerability, as described for the DEP, including the full dose-ramp schedule; the OLE iTD may have been different from the DEP/RWP iTD. SYNB1934v1 and placebo (color matched) consisted of powder for oral suspension packaged in sachets and resuspended in water or apple juice. Investigational medical product (IMP, ie, SYNB1934v1 or placebo) was administered orally immediately after meals.
DEP (Part 1) Study terminated by Sponsor	28
DEP (Part 1) Withdrawal by Subject	3
DEP (Part 1) Non-compliance with study drug	2
DEP (Part 1) Adverse Event	1
DEP (Part 1) Lost to Follow-up	1
RWP (Part 2, SYNB1934v1) Study terminated by Sponsor	7
RWP (Part 2, SYNB1934v1) Non-compliance with study drug	2
RWP (Part 2, Placebo) Study terminated by Sponsor	8
OLE (Part 3) Study terminated by Sponsor	10

Baseline Characteristics

Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=35 Participants In the DEP (Part 1), participants received SYNB1934v1 on the following dose-ramp regimen: Dose level 1 (Days 1-9): 3 × 10\^11 live cells partial dose up to TID; Dose level 2 (Weeks 4-6): 6 × 10\^11 live cells up to TID; Dose level 3 (Weeks 7-9): 1 × 10\^12 live cells up to TID. In the RWP (Part 2), participants who completed the DEP were randomized 1:1 to receive SYNB1934v1 at their iTD established in the DEP (no modifications permitted). In the OLE (Part 3), participants completed a dose ramp to their iTD guided by tolerability, as described for the DEP, including the full dose-ramp schedule; the OLE iTD may have been different from the DEP/RWP iTD. SYNB1934v1 and placebo (color matched) consisted of powder for oral suspension packaged in sachets and resuspended in water or apple juice. IMP was administered orally immediately after meals.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	31.0 years n=99 Participants
Sex: Female, Male Female	11 Participants n=99 Participants
Sex: Female, Male Male	24 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	2 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants
Race (NIH/OMB) White	30 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment Canada	10 participants n=99 Participants
Region of Enrollment United States	25 participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 15 weeks

Population: Participants who received at least 1 dose of IMP during the DEP, achieved an iTD, and had Week 3 blood Phe measured.

Outcome measures

Outcome measures
Measure	iTD of 3 x 10^11 Live Cells Participants received SYNB1934v1 orally immediately after meals. SYNB1934v1 consisted of powder for oral suspension packaged in sachets and resuspended in water or apple juice prior to administration.	iTD of 6 x 10^11 Live Cells n=1 Participants Participants received SYNB1934v1 orally immediately after meals. SYNB1934v1 consisted of powder for oral suspension packaged in sachets and resuspended in water or apple juice prior to administration.	iTD of 1 x 10^12 Live Cells n=14 Participants Participants received SYNB1934v1 orally immediately after meals. SYNB1934v1 consisted of powder for oral suspension packaged in sachets and resuspended in water or apple juice prior to administration.	Overall DEP n=15 Participants Participants received SYNB1934v1 orally immediately after meals. SYNB1934v1 consisted of powder for oral suspension packaged in sachets and resuspended in water or apple juice prior to administration.
Mean Percent Change From DEP Baseline in Blood Phenylalanine (Phe) Level at Week 3 of iTD During the DEP	—	-3.85 percent change Interval 0.0 to -3.85	5.33 percent change Interval -37.2 to 59.3	3.35 percent change Interval -37.2 to 59.3

SECONDARY outcome

Timeframe: Up to 15 weeks

Population: Participants who received at least 1 dose of IMP during the DEP, achieved an iTD, and had Week 3 blood Phe measured.

Outcome measures

Outcome measures
Measure	iTD of 3 x 10^11 Live Cells Participants received SYNB1934v1 orally immediately after meals. SYNB1934v1 consisted of powder for oral suspension packaged in sachets and resuspended in water or apple juice prior to administration.	iTD of 6 x 10^11 Live Cells n=1 Participants Participants received SYNB1934v1 orally immediately after meals. SYNB1934v1 consisted of powder for oral suspension packaged in sachets and resuspended in water or apple juice prior to administration.	iTD of 1 x 10^12 Live Cells n=14 Participants Participants received SYNB1934v1 orally immediately after meals. SYNB1934v1 consisted of powder for oral suspension packaged in sachets and resuspended in water or apple juice prior to administration.	Overall DEP n=15 Participants Participants received SYNB1934v1 orally immediately after meals. SYNB1934v1 consisted of powder for oral suspension packaged in sachets and resuspended in water or apple juice prior to administration.
Absolute Change From DEP Baseline in Blood Phe Level at Week 3 of iTD During the DEP	—	-55.00 µmol/L Interval 0.0 to -55.0	55.25 µmol/L Interval -227.0 to 406.5	30.50 µmol/L Interval -227.0 to 406.5

SECONDARY outcome

Timeframe: Up to 15 weeks

Population: Participants who received at least 1 dose of IMP during the DEP, achieved an iTD, and had blood Phe measured.

Baseline for blood Phe level in the DEP was defined as the mean of the duplicate blood Phe level measurements obtained immediately prior to administration of the first dose in the DEP. If only 1 blood Phe level measurement was available, then that measure was used as baseline. Blood Phe level was measured at each dose level after 3 weeks at that level.

Outcome measures

Outcome measures
Measure	iTD of 3 x 10^11 Live Cells n=1 Participants Participants received SYNB1934v1 orally immediately after meals. SYNB1934v1 consisted of powder for oral suspension packaged in sachets and resuspended in water or apple juice prior to administration.	iTD of 6 x 10^11 Live Cells n=1 Participants Participants received SYNB1934v1 orally immediately after meals. SYNB1934v1 consisted of powder for oral suspension packaged in sachets and resuspended in water or apple juice prior to administration.	iTD of 1 x 10^12 Live Cells n=15 Participants Participants received SYNB1934v1 orally immediately after meals. SYNB1934v1 consisted of powder for oral suspension packaged in sachets and resuspended in water or apple juice prior to administration.	Overall DEP n=17 Participants Participants received SYNB1934v1 orally immediately after meals. SYNB1934v1 consisted of powder for oral suspension packaged in sachets and resuspended in water or apple juice prior to administration.
Number of Participants With a ≥ 20% Reduction From Baseline in Blood Phe Level at Any Time in the DEP	0 Participants	0 Participants	6 Participants	6 Participants

Adverse Events

DEP (Part 1, SYNB1934v1)

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

RWP (Part 2, SYNB1934v1)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

RWP (Part 2, Placebo)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

OLE (Part 3, SYNB1934v1)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Clinical Operations

Synlogic

Phone: (617) 401-9975

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Other adverse events
Measure	DEP (Part 1, SYNB1934v1) n=35 participants at risk Participants received SYNB1934v1 orally immediately after meals on the following dose-ramp regimen: Dose level 1 (Days 1-9): 3 × 10\^11 live cells partial dose up to TID; Dose level 2 (Weeks 4-6): 6 × 10\^11 live cells up to TID; Dose level 3 (Weeks 7-9): 1 × 10\^12 live cells up to TID. SYNB1934v1 consisted of powder for oral suspension packaged in sachets and resuspended in water or apple juice prior to administration.	RWP (Part 2, SYNB1934v1) n=9 participants at risk Participants who completed the DEP were randomized 1:1 to receive SYNB1934v1 at their iTD established in the DEP orally immediately after meals. Participants remained on this dose of SYNB1934v1 for the duration of the RWP. SYNB1934v1 consisted of powder for oral suspension packaged in sachets and resuspended in water or apple juice prior to administration.	RWP (Part 2, Placebo) n=8 participants at risk Participants who completed the DEP were randomized 1:1 to receive placebo orally immediately after meals. Participants remained on this dose of placebo for the duration of the RWP. Placebo consisted of inactive powder (color matched to SYNB1934v1) for oral suspension packaged in sachets and resuspended in water or apple juice prior to administration.	OLE (Part 3, SYNB1934v1) n=10 participants at risk Participants completed a dose ramp to their iTD guided by tolerability, as described for the DEP, including the full dose-ramp schedule. The iTD in OLE may have been different from the iTD in the DEP or RWP. SYNB1934v1 consisted of powder for oral suspension packaged in sachets and resuspended in water or apple juice prior to administration.
Cardiac disorders Cardiac failure congestive	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Nausea	31.4% 11/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	10.0% 1/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Flatulence	25.7% 9/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	12.5% 1/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Abdominal distension	20.0% 7/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	10.0% 1/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Diarrhoea	20.0% 7/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	10.0% 1/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Abdominal pain	14.3% 5/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	10.0% 1/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Constipation	14.3% 5/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Abdominal pain lower	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Faeces soft	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Gastrointestinal pain	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Gastrointestinal sounds abnormal	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Gastrooesophageal reflux disease	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	10.0% 1/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Gastrointestinal disorders Vomiting	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
General disorders Fatigue	5.7% 2/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
General disorders Influenza like illness	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	22.2% 2/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	12.5% 1/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Infections and infestations Nasopharyngitis	14.3% 5/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Infections and infestations COVID-19	8.6% 3/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Infections and infestations Gastroenteritis	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	12.5% 1/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Infections and infestations Oral herpes	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Infections and infestations Upper respiratory tract infection	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Infections and infestations Wound infection	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Investigations Weight decreased	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Musculoskeletal and connective tissue disorders Costochondritis	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Musculoskeletal and connective tissue disorders Pain in extremity	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Musculoskeletal and connective tissue disorders Subchondral insufficiency fracture	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Nervous system disorders Headache	8.6% 3/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	20.0% 2/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Nervous system disorders Sinus headache	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Psychiatric disorders Affect lability	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Psychiatric disorders Agitation	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Psychiatric disorders Anxiety	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Psychiatric disorders Insomnia	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Psychiatric disorders Mood swings	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Reproductive system and breast disorders Ovarian cyst	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Skin and subcutaneous tissue disorders Acne	2.9% 1/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Infections and infestations Viral infection	0.00% 0/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	12.5% 1/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Infections and infestations Eye infection	0.00% 0/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	11.1% 1/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Infections and infestations Folliculitis	0.00% 0/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	11.1% 1/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	12.5% 1/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Nervous system disorders Memory impairment	0.00% 0/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	12.5% 1/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/35 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/9 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	12.5% 1/8 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.	0.00% 0/10 • All AEs occurring from the time a participant signed the informed consent form through the safety follow-up period and at least 1 month following the last dose of IMP were documented, regardless of causal assessment to IMP. Adverse event (AE) documentation included duration (start and end dates or ongoing), severity using the Common Terminology Criteria for Adverse Events (version 5.0), assessment of causality, and whether specific action or therapy was required. Within each study period, each AE term is counted only once per participant at the maximum reported grade.