Trial Outcomes & Findings for Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke (NCT NCT02448641)

NCT ID: NCT02448641

Last Updated: 2020-10-08

Results Overview

The FMMS is used as a clinical measure of body function impairment after stroke that assesses several dimensions of motor impairment, including range of motion in both upper and lower limbs, reflex activity, volitional movement, and co-ordination. The FMMS motor component consists of the 33-item upper extremity subscale (UE-FMMS) and the 17-item lower extremity subscale (LE-FMMS). Items were scored on a 3-point ordinal scale: 0= cannot perform; 1= partial motion; 2= full motion Individual items were then summed to determine scores for the 2 subscale scores, as well as a motor total score (total of all item scores including the 2 subscales UE-FMMS and LE-FMMS). As a result, the UE-FMMS subscale score ranged from 0 to 66 and the LE-FMMS subscale score ranged from 0 to 34. The FMMS motor total score ranged from 0 (hemiplegia) to a maximum of 100 points (normal motor performance). Responders: subjects whose FMMS motor total score improve by ≥10 points at Month 6 from Baseline

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 163 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2020-10-08

Participant Flow

Participant milestones

Measure	SB623 Implant (2.5M) 2.5 million SB623 cells SB623 Implant (2.5M): 2.5 million SB623 cells	SB623 Implant (5.0M) 5 million SB623 cells SB623 Implant (5.0M): 5 million SB623 cells	Sham Control Control Group: Sham surgery
Overall Study STARTED	55	56	52
Overall Study COMPLETED	54	51	48
Overall Study NOT COMPLETED	1	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke

Baseline characteristics by cohort

Measure	SB623 Implant (2.5M) n=55 Participants 2.5 million SB623 cells	SB623 Implant (5.0M) n=56 Participants 5 million SB623 cells	Sham Control n=52 Participants Control Group: Sham surgery	Total n=163 Participants Total of all reporting groups
Age, Continuous	57.5 years STANDARD_DEVIATION 11.08 • n=5 Participants	58.9 years STANDARD_DEVIATION 9.99 • n=7 Participants	55.2 years STANDARD_DEVIATION 11.57 • n=5 Participants	57.2 years STANDARD_DEVIATION 10.92 • n=4 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	60 Participants n=4 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	36 Participants n=7 Participants	33 Participants n=5 Participants	103 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=5 Participants	53 Participants n=7 Participants	52 Participants n=5 Participants	157 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants	9 participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants
Race/Ethnicity, Customized Black or African American	6 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants	9 participants n=4 Participants
Race/Ethnicity, Customized White	45 participants n=5 Participants	51 participants n=7 Participants	42 participants n=5 Participants	138 participants n=4 Participants
Race/Ethnicity, Customized Other	3 participants n=5 Participants	2 participants n=7 Participants	1 participants n=5 Participants	6 participants n=4 Participants
Region of Enrollment United States	55 participants n=5 Participants	56 participants n=7 Participants	52 participants n=5 Participants	163 participants n=4 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Modified Intent-to-Treat (mITT) Population: Included all randomized subjects who completed the surgery treatment procedure. A total of 111 subjects received treatment with SB623; 55 subjects were randomized to receive 2.5 million SB623 cells and 56 subjects to receive 5 million SB623 cells.

The FMMS is used as a clinical measure of body function impairment after stroke that assesses several dimensions of motor impairment, including range of motion in both upper and lower limbs, reflex activity, volitional movement, and co-ordination.

The FMMS motor component consists of the 33-item upper extremity subscale (UE-FMMS) and the 17-item lower extremity subscale (LE-FMMS). Items were scored on a 3-point ordinal scale:

0= cannot perform; 1= partial motion; 2= full motion

Individual items were then summed to determine scores for the 2 subscale scores, as well as a motor total score (total of all item scores including the 2 subscales UE-FMMS and LE-FMMS). As a result, the UE-FMMS subscale score ranged from 0 to 66 and the LE-FMMS subscale score ranged from 0 to 34. The FMMS motor total score ranged from 0 (hemiplegia) to a maximum of 100 points (normal motor performance).

Responders: subjects whose FMMS motor total score improve by ≥10 points at Month 6 from Baseline

Outcome measures

Measure	SB623 Implant (2.5M) n=55 Participants 2.5 million SB623 cells SB623 Implant (2.5M): 2.5 million SB623 cells	SB623 Implant (5.0M) n=56 Participants 5 million SB623 cells SB623 Implant (5.0M): 5 million SB623 cells	Sham Control n=52 Participants Sham surgery Sham surgery
Proportion of Subjects Whose Fugl-Meyer Motor Total Score (FMMS) Improved by ≥ 10 Points at Month 6 From Baseline Responder	7 Participants	9 Participants	7 Participants
Proportion of Subjects Whose Fugl-Meyer Motor Total Score (FMMS) Improved by ≥ 10 Points at Month 6 From Baseline Non-responder	46 Participants	45 Participants	38 Participants
Proportion of Subjects Whose Fugl-Meyer Motor Total Score (FMMS) Improved by ≥ 10 Points at Month 6 From Baseline Unknown	2 Participants	2 Participants	7 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Modified Intent-to-Treat (mITT) Population: Included all randomized subjects who completed the surgery treatment procedure. A total of 111 subjects received treatment with SB623; 55 subjects were randomized to receive 2.5 million SB623 cells and 56 subjects to receive 5 million SB623 cells.

Responders: The subjects that improved at least one point on the mRS from Baseline

Modified Rankin Scale (mRS): This scale is used to measure the degree of disability or dependence in the daily activities of people who had suffered a stroke. The mRS is an ordinal scale from 0 (no symptoms at all) to 5 (severe disability; requiring constant nursing care and attention, bedridden, incontinent) with a sixth category of death.

Outcome measures

Measure	SB623 Implant (2.5M) n=55 Participants 2.5 million SB623 cells SB623 Implant (2.5M): 2.5 million SB623 cells	SB623 Implant (5.0M) n=56 Participants 5 million SB623 cells SB623 Implant (5.0M): 5 million SB623 cells	Sham Control n=52 Participants Sham surgery Sham surgery
Modified Rankin Scale Response: The Proportion of Subjects That Improved at Least One Point on the mRS From Baseline Responder	6 Participants	10 Participants	9 Participants
Modified Rankin Scale Response: The Proportion of Subjects That Improved at Least One Point on the mRS From Baseline Non-responder	43 Participants	42 Participants	35 Participants
Modified Rankin Scale Response: The Proportion of Subjects That Improved at Least One Point on the mRS From Baseline Unknown	6 Participants	4 Participants	8 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Modified Intent-to-Treat (mITT) Population: Included all randomized subjects who completed the surgery treatment procedure. A total of 111 subjects received treatment with SB623; 55 subjects were randomized to receive 2.5 million SB623 cells and 56 subjects to receive 5 million SB623 cells.

Responders: The subjects that improved at least 6 points from Baseline on the ARAT total score at the affected side.

Action Research Arm Test (ARAT): The test was scored for left and right side separately. Performance on each item was rated on a 4-point ordinal scale ranging from: 3 (performed test normally in less than 5 seconds); 2 (completed test, but took abnormally long or had great difficult, with time varying from 5 to 60 seconds; 1 (performed test partially); 0 (could perform no part of the test). The ARAT is a 19-item measure divided into 4 subtests: Grasp subscale (with 6 items and a score range of 0 to 18); Grip subscale with 4 items and a score range of 0 to 12); Pinch subscale with 6 items and a score range of 0 to 18); Gross arm movement subscale (with 3 items and a score range of 0 to 9). The maximum score on the ARAT is 57 points (possible range 0 to 57) for each side.

Outcome measures

Measure	SB623 Implant (2.5M) n=55 Participants 2.5 million SB623 cells SB623 Implant (2.5M): 2.5 million SB623 cells	SB623 Implant (5.0M) n=56 Participants 5 million SB623 cells SB623 Implant (5.0M): 5 million SB623 cells	Sham Control n=52 Participants Sham surgery Sham surgery
The Proportion of Subjects That Improved at Least 6 Points From Baseline on the ARAT Total Score at the Affected Side Responder	6 Participants	9 Participants	9 Participants
The Proportion of Subjects That Improved at Least 6 Points From Baseline on the ARAT Total Score at the Affected Side Non-responder	47 Participants	45 Participants	37 Participants
The Proportion of Subjects That Improved at Least 6 Points From Baseline on the ARAT Total Score at the Affected Side Unknown	2 Participants	2 Participants	6 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Modified Intent-to-Treat (mITT) Population: Included all randomized subjects who completed the surgery treatment procedure. A total of 111 subjects received treatment with SB623; 55 subjects were randomized to receive 2.5 million SB623 cells and 56 subjects to receive 5 million SB623 cells.

Responders: The subjects that improved at least 1 functional level (eg, from < 0.4 m/s to 0.4-0.8 m/s or from 0.4-0.8 m/s to > 0.8 m/s) from Baseline on Gait Velocity.

Gait Velocity was measured on a standard 10 meter walk. Two trials were tested and the average result from both was used for analysis

Outcome measures

Measure	SB623 Implant (2.5M) n=55 Participants 2.5 million SB623 cells SB623 Implant (2.5M): 2.5 million SB623 cells	SB623 Implant (5.0M) n=56 Participants 5 million SB623 cells SB623 Implant (5.0M): 5 million SB623 cells	Sham Control n=52 Participants Sham surgery Sham surgery
The Proportion of Subjects That Improved at Least 1 Functional Level From Baseline on Gait Velocity Responder	7 Participants	6 Participants	5 Participants
The Proportion of Subjects That Improved at Least 1 Functional Level From Baseline on Gait Velocity Non-respinder	39 Participants	43 Participants	36 Participants
The Proportion of Subjects That Improved at Least 1 Functional Level From Baseline on Gait Velocity Unknown	9 Participants	7 Participants	11 Participants

SECONDARY outcome

Timeframe: 6 Months

Population: Modified Intent-to-Treat (mITT) Population: Included all randomized subjects who completed the surgery treatment procedure. A total of 111 subjects received treatment with SB623; 55 subjects were randomized to receive 2.5 million SB623 cells and 56 subjects to receive 5 million SB623 cells.

The Neurological Quality of Life (NeuroQOL) was used as a measure of change in the levels of Quality of Life, Satisfaction and Participation, secondary to improvements in the subject's upper and lower extremity motor function. NeuroQOL is summation of item scores for upper extremity (8 terms: score 8 - 40) and lower extremity (8 items: score 8 - 40) separately. The item scores are on a 1 to 5 scale (1 = unable to do; 2 = with much difficulty; 3 = with some difficulty; 4 = with little difficulty; 5 = without any difficulty). The result provided here shows NeuroQOL score converted to T-score. The range for Upper extremity T-score and Lower extremity T-score are 12.8 to 53.8 and 16.5 to 58.6 respectively.

Outcome measures

Measure	SB623 Implant (2.5M) n=55 Participants 2.5 million SB623 cells SB623 Implant (2.5M): 2.5 million SB623 cells	SB623 Implant (5.0M) n=56 Participants 5 million SB623 cells SB623 Implant (5.0M): 5 million SB623 cells	Sham Control n=52 Participants Sham surgery Sham surgery
Neurological Quality of Life Response: T-scores of the Change From Baseline in the 2 Sub-domains (Upper Extremity Function and Lower Extremity Function) Upper Extremity Function	0.14 Change in score on a scale from baseline Standard Error 2.018	-1.08 Change in score on a scale from baseline Standard Error 2.000	-0.11 Change in score on a scale from baseline Standard Error 1.946
Neurological Quality of Life Response: T-scores of the Change From Baseline in the 2 Sub-domains (Upper Extremity Function and Lower Extremity Function) Lower Extremity Function	1.61 Change in score on a scale from baseline Standard Error 1.343	2.74 Change in score on a scale from baseline Standard Error 1.331	1.60 Change in score on a scale from baseline Standard Error 1.301

SECONDARY outcome

Timeframe: 6 Months (LOCF)

Population: Modified Intent-to-Treat (mITT) Population: Included all randomized subjects who completed the surgery treatment procedure. A total of 111 subjects received treatment with SB623; 55 subjects were randomized to receive 2.5 million SB623 cells and 56 subjects to receive 5 million SB623 cells.

Responders: Participants who scored either 7 [much better] or 6 [a little better, meaningful])

Global Rating of Perceived Change from Baseline: Subjects and Clinicians were asked about perceived changes in their motor function by comparing "how well they are doing compared to before the surgical procedure". The Subject Global Rating of Perceived Change was completed by the subject (or by the caregiver using the subject's answers). The following 7-point Likert scale was used: Score 7 (much better); Score 6 (a little better, meaningful); Score 5 (a little better, not meaningful); Score 4 (about the same); Score 3 (a little worse, not meaningful); Score 2 (a little worse, meaningful); Score 1 (much worse)

Outcome measures

Measure	SB623 Implant (2.5M) n=55 Participants 2.5 million SB623 cells SB623 Implant (2.5M): 2.5 million SB623 cells	SB623 Implant (5.0M) n=56 Participants 5 million SB623 cells SB623 Implant (5.0M): 5 million SB623 cells	Sham Control n=52 Participants Sham surgery Sham surgery
Global Rating of Perceived Change (GRPC): The Proportion of Subjects Scoring Either 7 or 6 on the Global Rating of Perceived Change by Both Subject and Clinician As per Subject · Unknown	0 Participants	0 Participants	0 Participants
Global Rating of Perceived Change (GRPC): The Proportion of Subjects Scoring Either 7 or 6 on the Global Rating of Perceived Change by Both Subject and Clinician As per Clinician · Responder	15 Participants	18 Participants	13 Participants
Global Rating of Perceived Change (GRPC): The Proportion of Subjects Scoring Either 7 or 6 on the Global Rating of Perceived Change by Both Subject and Clinician As per Clinician · Non-responder	39 Participants	38 Participants	39 Participants
Global Rating of Perceived Change (GRPC): The Proportion of Subjects Scoring Either 7 or 6 on the Global Rating of Perceived Change by Both Subject and Clinician As per Clinician · Unknown	1 Participants	0 Participants	0 Participants
Global Rating of Perceived Change (GRPC): The Proportion of Subjects Scoring Either 7 or 6 on the Global Rating of Perceived Change by Both Subject and Clinician As per Subject · Responder	18 Participants	25 Participants	22 Participants
Global Rating of Perceived Change (GRPC): The Proportion of Subjects Scoring Either 7 or 6 on the Global Rating of Perceived Change by Both Subject and Clinician As per Subject · Non-responder	37 Participants	31 Participants	30 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 Months

Population: Modified Intent-to-Treat (mITT) Population: Included all randomized subjects who completed the surgery treatment procedure. A total of 111 subjects received treatment with SB623; 55 subjects were randomized to receive 2.5 million SB623 cells and 56 subjects to receive 5 million SB623 cells.

An additional analysis using mixed model for repeated measures (MMRM) was performed treating the change from Baseline in FMMS total score as a continuous outcome (dependent) variable. The independent variables were treatment, visit, treatment-by-visit interaction, and pooled surgical site as effects, and Baseline FMMS total score and Baseline mRS score as covariates. Least-squares means (LS-mean) with SE was calculated for the change from baseline measurements.

Outcome measures

Measure	SB623 Implant (2.5M) n=55 Participants 2.5 million SB623 cells SB623 Implant (2.5M): 2.5 million SB623 cells	SB623 Implant (5.0M) n=56 Participants 5 million SB623 cells SB623 Implant (5.0M): 5 million SB623 cells	Sham Control n=52 Participants Sham surgery Sham surgery
Additional Analysis (MMRM), Fugl-Meyer Motor Scale (FMMS)	5.3 Change in score on a scale from baseline Standard Error 1.64	4.5 Change in score on a scale from baseline Standard Error 1.62	3.6 Change in score on a scale from baseline Standard Error 1.59

OTHER_PRE_SPECIFIED outcome

Timeframe: Month 6

Population: Per Protocol (PP) Population: The PP population included all subjects in the mITT population who did not have important protocol deviations.

Responders: subjects whose FMMS motor total score improve by ≥10 points at Month 6 from Baseline

Outcome measures

Measure	SB623 Implant (2.5M) n=41 Participants 2.5 million SB623 cells SB623 Implant (2.5M): 2.5 million SB623 cells	SB623 Implant (5.0M) n=46 Participants 5 million SB623 cells SB623 Implant (5.0M): 5 million SB623 cells	Sham Control n=46 Participants Sham surgery Sham surgery
Proportion of Subjects Whose FMMS Motor Total Score Improve by ≥10 Points at Month 6 From Baseline (Per Protocol Population) Unknown	1 Participants	2 Participants	4 Participants
Proportion of Subjects Whose FMMS Motor Total Score Improve by ≥10 Points at Month 6 From Baseline (Per Protocol Population) Responder	6 Participants	9 Participants	7 Participants
Proportion of Subjects Whose FMMS Motor Total Score Improve by ≥10 Points at Month 6 From Baseline (Per Protocol Population) Non-responder	34 Participants	35 Participants	35 Participants

Adverse Events

SB623 Implant (2.5M)

Serious events: 15 serious events

Other events: 52 other events

Deaths: 0 deaths

SB623 Implant (5.0M)

Serious events: 15 serious events

Other events: 53 other events

Deaths: 1 deaths

Sham Control

Serious events: 10 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Measure	SB623 Implant (2.5M) n=55 participants at risk 2.5 million SB623 cells SB623 Implant (2.5M): 2.5 million SB623 cells	SB623 Implant (5.0M) n=56 participants at risk 5 million SB623 cells SB623 Implant (5.0M): 5 million SB623 cells	Sham Control n=52 participants at risk Control Group: Sham surgery Group
Blood and lymphatic system disorders Haemorrhagic anaemia	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.8% 1/56 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Cardiac disorders Atrial fibrillation	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.8% 1/56 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Cardiac disorders Pericardial effusion	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Cardiac disorders Ventricular tachycardia	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Cardiac disorders Bradycardia	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Ear and labyrinth disorders Vertigo	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Gastrointestinal disorders Nausea	3.6% 2/55 • Number of events 2 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Gastrointestinal disorders Abdominal pain	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Gastrointestinal disorders Vomiting	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Gastrointestinal disorders Pancreatitis	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
General disorders Pyrexia	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	3.6% 2/56 • Number of events 2 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
General disorders Asthenia	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.8% 1/56 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
General disorders Chest pain	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Infections and infestations Pneumonia	3.6% 2/55 • Number of events 3 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Infections and infestations Sepsis	1.8% 1/55 • Number of events 2 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Infections and infestations Pancreas infection	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.8% 1/56 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Infections and infestations Urinary tract infection	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.8% 1/56 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Infections and infestations Wound infection	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Infections and infestations Bronchopneumonia	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Infections and infestations Cellulitis	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Infections and infestations Influenza	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Infections and infestations Intervertebral discitis	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Infections and infestations Staphylococcal osteomyelitis	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Injury, poisoning and procedural complications Subdural haematoma	5.5% 3/55 • Number of events 3 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.8% 1/56 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	3.6% 2/56 • Number of events 2 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Injury, poisoning and procedural complications Contusion	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Injury, poisoning and procedural complications Crush injury	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Injury, poisoning and procedural complications Fall	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.8% 1/56 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.8% 1/56 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Injury, poisoning and procedural complications Humerus fracture	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Injury, poisoning and procedural complications Incision site complication	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Injury, poisoning and procedural complications Ligament sprain	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Injury, poisoning and procedural complications Pneumocephalus	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.8% 1/56 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Injury, poisoning and procedural complications Upper limb fracture	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Injury, poisoning and procedural complications Wound dehiscence	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Investigations Anti factor X antibody positive	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.8% 1/56 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.8% 1/56 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.8% 1/56 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Nervous system disorders Seizure	7.3% 4/55 • Number of events 4 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	7.1% 4/56 • Number of events 5 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	5.8% 3/52 • Number of events 4 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Nervous system disorders Basal ganglia haemorrhage	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Nervous system disorders Generalised tonic-clonic seizure	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Nervous system disorders Seizure like phenomena	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Nervous system disorders Syncope	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.8% 1/56 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Nervous system disorders Encephalopathy	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Nervous system disorders Transient ischaemic attack	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Psychiatric disorders Suicidal ideation	1.8% 1/55 • Number of events 2 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Renal and urinary disorders Renal failure	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.8% 1/56 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Renal and urinary disorders Urinary retention	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Renal and urinary disorders Acute kidney injury	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Vascular disorders Hypotension	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/56 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.

Other adverse events

Measure	SB623 Implant (2.5M) n=55 participants at risk 2.5 million SB623 cells SB623 Implant (2.5M): 2.5 million SB623 cells	SB623 Implant (5.0M) n=56 participants at risk 5 million SB623 cells SB623 Implant (5.0M): 5 million SB623 cells	Sham Control n=52 participants at risk Control Group: Sham surgery Group
Eye disorders Eye swelling	5.5% 3/55 • Number of events 3 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.8% 1/56 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Gastrointestinal disorders Nausea	23.6% 13/55 • Number of events 13 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	21.4% 12/56 • Number of events 12 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	5.8% 3/52 • Number of events 3 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Gastrointestinal disorders Vomiting	18.2% 10/55 • Number of events 10 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	10.7% 6/56 • Number of events 6 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Gastrointestinal disorders Constipation	9.1% 5/55 • Number of events 5 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	3.6% 2/56 • Number of events 2 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	7.7% 4/52 • Number of events 5 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Gastrointestinal disorders Diarrhoea	5.5% 3/55 • Number of events 3 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.8% 1/56 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
General disorders Fatigue	5.5% 3/55 • Number of events 3 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	5.4% 3/56 • Number of events 3 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	7.7% 4/52 • Number of events 4 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
General disorders Pyrexia	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	5.4% 3/56 • Number of events 3 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
General disorders Pain	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	5.4% 3/56 • Number of events 3 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Infections and infestations Urinary tract infection	3.6% 2/55 • Number of events 3 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	8.9% 5/56 • Number of events 5 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Infections and infestations Upper respiratory tract infection	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	7.1% 4/56 • Number of events 5 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	3.8% 2/52 • Number of events 2 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Infections and infestations Nasopharyngitis	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	3.6% 2/56 • Number of events 2 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	5.8% 3/52 • Number of events 3 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Injury, poisoning and procedural complications Procedural headache	14.5% 8/55 • Number of events 9 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	16.1% 9/56 • Number of events 9 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	25.0% 13/52 • Number of events 13 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Injury, poisoning and procedural complications Procedural pain	20.0% 11/55 • Number of events 11 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	8.9% 5/56 • Number of events 5 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	11.5% 6/52 • Number of events 6 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Injury, poisoning and procedural complications Fall	9.1% 5/55 • Number of events 8 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	8.9% 5/56 • Number of events 5 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	7.7% 4/52 • Number of events 12 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Injury, poisoning and procedural complications Incision site pain	9.1% 5/55 • Number of events 5 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	8.9% 5/56 • Number of events 5 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	19.2% 10/52 • Number of events 10 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Injury, poisoning and procedural complications Contusion	3.6% 2/55 • Number of events 4 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	5.4% 3/56 • Number of events 3 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Injury, poisoning and procedural complications Skin abrasion	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	5.4% 3/56 • Number of events 3 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	3.8% 2/52 • Number of events 3 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Musculoskeletal and connective tissue disorders Back pain	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	7.1% 4/56 • Number of events 4 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	7.1% 4/56 • Number of events 4 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	9.6% 5/52 • Number of events 5 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Nervous system disorders Headache	63.6% 35/55 • Number of events 42 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	73.2% 41/56 • Number of events 48 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	61.5% 32/52 • Number of events 35 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Nervous system disorders Paraesthesia	1.8% 1/55 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	5.4% 3/56 • Number of events 4 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	3.8% 2/52 • Number of events 2 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Nervous system disorders Dizziness	0.00% 0/55 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	5.4% 3/56 • Number of events 5 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	1.9% 1/52 • Number of events 1 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Psychiatric disorders Depression	10.9% 6/55 • Number of events 7 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	5.4% 3/56 • Number of events 3 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	0.00% 0/52 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.
Skin and subcutaneous tissue disorders Swelling face	3.6% 2/55 • Number of events 3 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	3.6% 2/56 • Number of events 2 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.	9.6% 5/52 • Number of events 5 • Safety was monitored throughout the study. The adverse event reporting period for this trial began upon informed consent and ended 12 months after the administration of SB623, or at Early Termination. Also, an external Data Safety Monitoring Board (DSMB) was utilized to review safety data, including clinical symptoms, laboratory findings, and MRI brain imaging. The DSMB reviewed study data within one month of the enrollment of subjects at the 25%, 50%, and 75% of the total population.

Additional Information

Bijan Nejadnik M.D.; Chief Medical Officer

SanBio, Inc.

Phone: 650-625-2205

Email: Bijan.Nejadnik@sanbio.com

Results disclosure agreements

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