Trial Outcomes & Findings for VTS-270 to Treat Niemann-Pick Type C1 (NPC1) Disease (NCT NCT02534844)

NCT ID: NCT02534844

Last Updated: 2023-02-22

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

56 participants

Primary outcome timeframe

Baseline, Week 52

Results posted on

2023-02-22

Participant Flow

Participant milestones

Participant milestones
Measure	Part A: Adrabetadex 900 mg Participants received 4 lumbar intrathecal (IT) infusions of adrabetadex 900 milligrams (mg) once every 2 weeks.	Part A: Adrabetadex 1200 mg Participants received 4 lumbar IT infusions of adrabetadex 1200 mg once every 2 weeks.	Part A: Adrabetadex 1800 mg Participants received 4 lumbar IT infusions of adrabetadex 1800 mg once every 2 weeks.	Part A: Sham Control Participants received sham control procedures once every 2 weeks.	Part B: Adrabetadex 900 mg Participants received lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part B: Sham Control Participants received sham control procedures once every 2 weeks.
Part A STARTED	3	3	3	3	0	0
Part A Received at Least One Dose of Study Drug	3	3	3	3	0	0
Part A COMPLETED	3	3	3	3	0	0
Part A NOT COMPLETED	0	0	0	0	0	0
Part B STARTED	0	0	0	0	29	15
Part B Received at Least One Dose of Study Drug	0	0	0	0	29	15
Part B COMPLETED	0	0	0	0	27	14
Part B NOT COMPLETED	0	0	0	0	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Adrabetadex 900 mg Participants received 4 lumbar intrathecal (IT) infusions of adrabetadex 900 milligrams (mg) once every 2 weeks.	Part A: Adrabetadex 1200 mg Participants received 4 lumbar IT infusions of adrabetadex 1200 mg once every 2 weeks.	Part A: Adrabetadex 1800 mg Participants received 4 lumbar IT infusions of adrabetadex 1800 mg once every 2 weeks.	Part A: Sham Control Participants received sham control procedures once every 2 weeks.	Part B: Adrabetadex 900 mg Participants received lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part B: Sham Control Participants received sham control procedures once every 2 weeks.
Part B Withdrawal by Subject	0	0	0	0	2	1

Baseline Characteristics

VTS-270 to Treat Niemann-Pick Type C1 (NPC1) Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham Control n=18 Participants Participants received sham control procedures once every 2 weeks for a total of 52 weeks.	Adrabetadex n=38 Participants Participants received lumbar IT infusions of adrabetadex once every 2 weeks for a total of 52 weeks.	Total n=56 Participants Total of all reporting groups
Age, Continuous	11.7 years STANDARD_DEVIATION 5.10 • n=99 Participants	12.7 years STANDARD_DEVIATION 5.64 • n=107 Participants	12.4 years STANDARD_DEVIATION 5.45 • n=206 Participants
Sex: Female, Male Female	10 Participants n=99 Participants	16 Participants n=107 Participants	26 Participants n=206 Participants
Sex: Female, Male Male	8 Participants n=99 Participants	22 Participants n=107 Participants	30 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=99 Participants	31 Participants n=107 Participants	46 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	4 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	4 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) White	16 Participants n=99 Participants	31 Participants n=107 Participants	47 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline, Week 52

Population: Modified intent-to-treat (mITT) population included all randomized participants who received at least one treatment (sham or adrabetadex). As per planned analysis, efficacy data were collected and presented by overall randomized treatment assignment (either sham or adrabetadex). These two treatment arms (either sham or adrabetadex) combine data from Parts A and B of the study. Here, number analyzed = participants evaluable at specified time-point.

Outcome measures

Outcome measures
Measure	Sham Control n=18 Participants Participants received sham control procedures once every 2 weeks for a total of 52 weeks.	Adrabetadex n=38 Participants Participants received lumbar IT infusions of adrabetadex once every 2 weeks for a total of 52 weeks.	Part A: Adrabetadex 1800 mg Participants received 4 lumbar IT infusions of adrabetadex 1800 mg once every 2 weeks.	Part A: Sham Control Participants received sham control procedures once every 2 weeks.	Part B: Adrabetadex 900 mg Participants received lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part B: Sham Control Participants received sham control procedures once every 2 weeks.
Parts A/B: Change From Baseline to Week 52 in 4-Item Composite Score of Niemann Pick Type C Severity Scale (NPC-SS) Score Baseline	8.1 score on a scale Standard Deviation 4.27	8.8 score on a scale Standard Deviation 3.12	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in 4-Item Composite Score of Niemann Pick Type C Severity Scale (NPC-SS) Score Change from Baseline at Week 52	-0.1 score on a scale Standard Deviation 1.55	0.0 score on a scale Standard Deviation 2.45	—	—	—	—

PRIMARY outcome

Timeframe: Week 52

Population: mITT population included all randomized participants who received at least one treatment (sham or adrabetadex). As per planned analysis, efficacy data were collected and presented by overall randomized treatment assignment (either sham or adrabetadex). These two treatment arms (either sham or adrabetadex) combine data from Parts A and B of the study.

The Clinician CGIC is a 7-point Likert scale. The scale requires assessment of change from a baseline level of disease activity, with anchors ranging from markedly improved, moderately improved, and minimally improved to no change and corresponding worsening (minimally, moderately, markedly). The Investigator rates his/her impression of the change in each participant's condition at week 52 on a scale from marked improvement (1) to marked worsening (7).

Outcome measures

Outcome measures
Measure	Sham Control n=18 Participants Participants received sham control procedures once every 2 weeks for a total of 52 weeks.	Adrabetadex n=38 Participants Participants received lumbar IT infusions of adrabetadex once every 2 weeks for a total of 52 weeks.	Part A: Adrabetadex 1800 mg Participants received 4 lumbar IT infusions of adrabetadex 1800 mg once every 2 weeks.	Part A: Sham Control Participants received sham control procedures once every 2 weeks.	Part B: Adrabetadex 900 mg Participants received lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part B: Sham Control Participants received sham control procedures once every 2 weeks.
Parts A/B: Number of Participants Classified With Each Score on the Clinician Global Impression of Change (CGIC) at Week 52 Moderately improved (2)	1 Participants	5 Participants	—	—	—	—
Parts A/B: Number of Participants Classified With Each Score on the Clinician Global Impression of Change (CGIC) at Week 52 Minimally improved (3)	4 Participants	9 Participants	—	—	—	—
Parts A/B: Number of Participants Classified With Each Score on the Clinician Global Impression of Change (CGIC) at Week 52 Minimally worse (5)	2 Participants	6 Participants	—	—	—	—
Parts A/B: Number of Participants Classified With Each Score on the Clinician Global Impression of Change (CGIC) at Week 52 Unchanged (4)	9 Participants	16 Participants	—	—	—	—
Parts A/B: Number of Participants Classified With Each Score on the Clinician Global Impression of Change (CGIC) at Week 52 Moderately worse (6)	2 Participants	1 Participants	—	—	—	—
Parts A/B: Number of Participants Classified With Each Score on the Clinician Global Impression of Change (CGIC) at Week 52 Markedly worse (7)	0 Participants	1 Participants	—	—	—	—
Parts A/B: Number of Participants Classified With Each Score on the Clinician Global Impression of Change (CGIC) at Week 52 Markedly improved (1)	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: mITT population included all randomized participants who received at least one treatment. As per planned analysis, efficacy data were collected and presented by overall randomized treatment assignment (either sham or adrabetadex). These two treatment arms (either sham or adrabetadex) combine data from Parts A and B of the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure. Number analyzed = participants evaluable at specified time-point.

The NPC-SS total score is based on 9 domains including ambulation, fine motor skills, cognition, swallowing, memory, speech, eye movement, hearing (sensorineural) and seizures. The hearing domain and auditory brainstem response modifiers are removed from the total NPC-SS total score for this measure. A Likert-like scale is used to assign the remaining 8 major domain scores of 0 to 5 (better to worse). The total score was the sum of individual component scores which ranges from 0 (best) to 40 (worst), with higher scores indicating more severe clinical impairment.

Outcome measures

Outcome measures
Measure	Sham Control n=18 Participants Participants received sham control procedures once every 2 weeks for a total of 52 weeks.	Adrabetadex n=37 Participants Participants received lumbar IT infusions of adrabetadex once every 2 weeks for a total of 52 weeks.	Part A: Adrabetadex 1800 mg Participants received 4 lumbar IT infusions of adrabetadex 1800 mg once every 2 weeks.	Part A: Sham Control Participants received sham control procedures once every 2 weeks.	Part B: Adrabetadex 900 mg Participants received lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part B: Sham Control Participants received sham control procedures once every 2 weeks.
Parts A/B: Change From Baseline to Week 52 in NPC-SS Total Score (Excluding Hearing and Auditory Brainstem Response [ABR]) Baseline	16.94 score on a scale Standard Deviation 8.164	17.81 score on a scale Standard Deviation 6.476	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in NPC-SS Total Score (Excluding Hearing and Auditory Brainstem Response [ABR]) Change from Baseline at Week 52	-0.74 score on a scale Standard Deviation 2.357	-0.34 score on a scale Standard Deviation 4.226	—	—	—	—

SECONDARY outcome

Timeframe: Week 52

Outcome measures

Outcome measures
Measure	Sham Control n=18 Participants Participants received sham control procedures once every 2 weeks for a total of 52 weeks.	Adrabetadex n=38 Participants Participants received lumbar IT infusions of adrabetadex once every 2 weeks for a total of 52 weeks.	Part A: Adrabetadex 1800 mg Participants received 4 lumbar IT infusions of adrabetadex 1800 mg once every 2 weeks.	Part A: Sham Control Participants received sham control procedures once every 2 weeks.	Part B: Adrabetadex 900 mg Participants received lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part B: Sham Control Participants received sham control procedures once every 2 weeks.
Parts A/ B: Number of Participants Classified as CGIC Responders at Week 52	7 Participants	23 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 52

The NPC-SS total score is based on 9 domains including ambulation, fine motor skills, cognition, swallowing, memory, speech, eye movement, hearing (sensorineural) and seizures. The hearing domain and ABR modifiers are removed from the total NPC-SS total score for this measure. A Likert-like scale is used to assign the remaining 8 major domain scores of 0 to 5 (better to worse). The total score was the sum of individual components scores which ranges from 0 (best) to 40 (worst), with higher scores indicating more severe clinical impairment. Responders on NPC-SS Total Score are defined as participants with no change or improvement on NPC-SS total score from baseline to Week 52.

Outcome measures

Outcome measures
Measure	Sham Control n=18 Participants Participants received sham control procedures once every 2 weeks for a total of 52 weeks.	Adrabetadex n=38 Participants Participants received lumbar IT infusions of adrabetadex once every 2 weeks for a total of 52 weeks.	Part A: Adrabetadex 1800 mg Participants received 4 lumbar IT infusions of adrabetadex 1800 mg once every 2 weeks.	Part A: Sham Control Participants received sham control procedures once every 2 weeks.	Part B: Adrabetadex 900 mg Participants received lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part B: Sham Control Participants received sham control procedures once every 2 weeks.
Parts A/B: Number of Participants Classified as Responders on NPC-SS Total Score (Excluding Hearing and ABR) at Week 52	13 Participants	22 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 52

The EQ-5D-3L assessment is a self-reported, simple, descriptive system measuring 5 dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. A vertical VAS allows the participants to indicate their health state that day, and ranges from 0 (worst imaginable) to 100 (best imaginable), with higher scores indicating better health state.

Outcome measures

Outcome measures
Measure	Sham Control n=18 Participants Participants received sham control procedures once every 2 weeks for a total of 52 weeks.	Adrabetadex n=37 Participants Participants received lumbar IT infusions of adrabetadex once every 2 weeks for a total of 52 weeks.	Part A: Adrabetadex 1800 mg Participants received 4 lumbar IT infusions of adrabetadex 1800 mg once every 2 weeks.	Part A: Sham Control Participants received sham control procedures once every 2 weeks.	Part B: Adrabetadex 900 mg Participants received lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part B: Sham Control Participants received sham control procedures once every 2 weeks.
Parts A/B: EQ-5D-3L Questionnaire Visual Analog Scale (VAS) Score (for Health Status) at Baseline and at Week 52 Baseline	71.9 score on a scale Standard Deviation 16.28	68.3 score on a scale Standard Deviation 19.97	—	—	—	—
Parts A/B: EQ-5D-3L Questionnaire Visual Analog Scale (VAS) Score (for Health Status) at Baseline and at Week 52 Week 52	73.2 score on a scale Standard Deviation 13.04	75.7 score on a scale Standard Deviation 19.00	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 26

Participants who manifested significant disease progression according to predefined clinical criteria after treatment of 26 weeks or more had the option to rescue. Number of participants who qualified for the rescue option following a minimum of 26 weeks of treatment were analyzed.

Outcome measures

Outcome measures
Measure	Sham Control n=18 Participants Participants received sham control procedures once every 2 weeks for a total of 52 weeks.	Adrabetadex n=38 Participants Participants received lumbar IT infusions of adrabetadex once every 2 weeks for a total of 52 weeks.	Part A: Adrabetadex 1800 mg Participants received 4 lumbar IT infusions of adrabetadex 1800 mg once every 2 weeks.	Part A: Sham Control Participants received sham control procedures once every 2 weeks.	Part B: Adrabetadex 900 mg Participants received lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part B: Sham Control Participants received sham control procedures once every 2 weeks.
Parts A/B: Number of Participants Treated for at Least 6 Months Who Qualified for the Rescue Option	2 Participants	2 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 52

The NPC-SS total score is based on 9 domains including ambulation, fine motor skills, cognition, swallowing, memory, speech, eye movement, hearing (sensorineural) and seizures. A Likert-like scale is used to assign to each domain score of 0 to 5 (better to worse) with higher scores indicating more severe clinical impairment.

Outcome measures

Outcome measures
Measure	Sham Control n=18 Participants Participants received sham control procedures once every 2 weeks for a total of 52 weeks.	Adrabetadex n=38 Participants Participants received lumbar IT infusions of adrabetadex once every 2 weeks for a total of 52 weeks.	Part A: Adrabetadex 1800 mg Participants received 4 lumbar IT infusions of adrabetadex 1800 mg once every 2 weeks.	Part A: Sham Control Participants received sham control procedures once every 2 weeks.	Part B: Adrabetadex 900 mg Participants received lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part B: Sham Control Participants received sham control procedures once every 2 weeks.
Parts A/B: Change From Baseline to Week 52 in Each of the 9 Clinical Domains of the NPC-SS Fine Motor (Change from Baseline at Week 52)	0.07 score on a scale Standard Deviation 0.917	0.24 score on a scale Standard Deviation 1.103	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in Each of the 9 Clinical Domains of the NPC-SS Cognition (Baseline)	2.56 score on a scale Standard Deviation 1.199	2.58 score on a scale Standard Deviation 1.222	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in Each of the 9 Clinical Domains of the NPC-SS Seizures (Baseline)	1.00 score on a scale Standard Deviation 1.572	1.13 score on a scale Standard Deviation 1.630	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in Each of the 9 Clinical Domains of the NPC-SS Ambulation (Baseline)	1.83 score on a scale Standard Deviation 1.150	2.21 score on a scale Standard Deviation 1.298	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in Each of the 9 Clinical Domains of the NPC-SS Ambulation (Change from Baseline at Week 52)	0.00 score on a scale Standard Deviation 0.679	0.06 score on a scale Standard Deviation 1.434	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in Each of the 9 Clinical Domains of the NPC-SS Fine Motor (Baseline)	2.06 score on a scale Standard Deviation 1.349	2.16 score on a scale Standard Deviation 1.128	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in Each of the 9 Clinical Domains of the NPC-SS Cognition (Change from Baseline at Week 52)	-0.14 score on a scale Standard Deviation 0.663	0.06 score on a scale Standard Deviation 0.919	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in Each of the 9 Clinical Domains of the NPC-SS Swallowing (Baseline)	1.67 score on a scale Standard Deviation 1.495	1.79 score on a scale Standard Deviation 1.398	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in Each of the 9 Clinical Domains of the NPC-SS Swallowing (Change from Baseline at Week 52)	0.00 score on a scale Standard Deviation 1.109	-0.29 score on a scale Standard Deviation 1.360	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in Each of the 9 Clinical Domains of the NPC-SS Memory (Baseline)	1.56 score on a scale Standard Deviation 1.294	1.63 score on a scale Standard Deviation 1.051	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in Each of the 9 Clinical Domains of the NPC-SS Memory (Change from Baseline at Week 52)	0.00 score on a scale Standard Deviation 0.784	0.18 score on a scale Standard Deviation 1.218	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in Each of the 9 Clinical Domains of the NPC-SS Speech (Baseline)	1.17 score on a scale Standard Deviation 0.707	1.42 score on a scale Standard Deviation 0.722	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in Each of the 9 Clinical Domains of the NPC-SS Speech (Change from Baseline at Week 52)	0.14 score on a scale Standard Deviation 0.663	-0.18 score on a scale Standard Deviation 0.673	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in Each of the 9 Clinical Domains of the NPC-SS Eye Movement (Baseline)	2.11 score on a scale Standard Deviation 0.471	1.92 score on a scale Standard Deviation 0.428	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in Each of the 9 Clinical Domains of the NPC-SS Eye Movement (Change from Baseline at Week 52)	0.00 score on a scale Standard Deviation 0.679	-0.06 score on a scale Standard Deviation 0.547	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in Each of the 9 Clinical Domains of the NPC-SS Hearing (Baseline)	0.94 score on a scale Standard Deviation 0.998	0.94 score on a scale Standard Deviation 1.145	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in Each of the 9 Clinical Domains of the NPC-SS Hearing (Change from Baseline at Week 52)	-0.22 score on a scale Standard Deviation 1.302	1.14 score on a scale Standard Deviation 1.236	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in Each of the 9 Clinical Domains of the NPC-SS Seizures (Change from Baseline at Week 52)	-0.50 score on a scale Standard Deviation 1.286	-0.06 score on a scale Standard Deviation 0.952	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: mITT population included all randomized participants who received at least one treatment). As per planned analysis, efficacy data were collected and presented by overall randomized treatment assignment (either sham or adrabetadex). These two treatment arms (either sham or adrabetadex) combine data from Parts A and B of the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure, and number analyzed = participants evaluable at specified time-point.

The NPC-SS total score is based on 9 domains including ambulation, fine motor skills, cognition, swallowing, memory, speech, eye movement, hearing (sensorineural) and seizures. A Likert-like scale is used to assign to each domain score of 0 to 5 (better to worse). The total score was the sum of individual components scores which ranges from 0 (best) to 45 (worst), with higher scores indicating more severe clinical impairment.

Outcome measures

Outcome measures
Measure	Sham Control n=14 Participants Participants received sham control procedures once every 2 weeks for a total of 52 weeks.	Adrabetadex n=25 Participants Participants received lumbar IT infusions of adrabetadex once every 2 weeks for a total of 52 weeks.	Part A: Adrabetadex 1800 mg Participants received 4 lumbar IT infusions of adrabetadex 1800 mg once every 2 weeks.	Part A: Sham Control Participants received sham control procedures once every 2 weeks.	Part B: Adrabetadex 900 mg Participants received lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part B: Sham Control Participants received sham control procedures once every 2 weeks.
Parts A/B: Change From Baseline to Week 52 in the Total NPC-SS (With Hearing Domain and ABR Modifier Included) Baseline	15.64 score on a scale Standard Deviation 7.531	17.76 score on a scale Standard Deviation 5.349	—	—	—	—
Parts A/B: Change From Baseline to Week 52 in the Total NPC-SS (With Hearing Domain and ABR Modifier Included) Change from Baseline at Week 52	0.000 score on a scale Standard Deviation 1.000	0.75 score on a scale Standard Deviation 4.500	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 52

The NPC-SS composite score is the sum of the ambulation, cognition, fine motor, and swallowing domains of the NPC-SS. Each of the four NPC-SS components (ambulation, cognition, fine motor, and swallowing) are rated on a scale from 0 (better) to 5 (worse). The total score was the sum of individual components scores which ranges from 0 (best) to 20 (worst), with higher scores indicating more severe clinical impairment. The product-limit survival analysis method is used to estimate the time to one point increase (worsening) in NPC-SS composite score. Time to worsening in NPC-SS Composite Score defined as the interval from study drug administration to a one point increase in the NPC-SS composite score. If a subject discontinued from the study prior to Week 52, then the subject was censored at time of discontinuation. If a subject completed the Week 52 visit, then the subject was censored at the time of last study visit.

Outcome measures

Outcome measures
Measure	Sham Control n=18 Participants Participants received sham control procedures once every 2 weeks for a total of 52 weeks.	Adrabetadex n=38 Participants Participants received lumbar IT infusions of adrabetadex once every 2 weeks for a total of 52 weeks.	Part A: Adrabetadex 1800 mg Participants received 4 lumbar IT infusions of adrabetadex 1800 mg once every 2 weeks.	Part A: Sham Control Participants received sham control procedures once every 2 weeks.	Part B: Adrabetadex 900 mg Participants received lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part B: Sham Control Participants received sham control procedures once every 2 weeks.
Parts A/B: Time to One Point Increase (Worsening) in NPC-SS Composite Score	118 Days Interval 55.0 to 364.0	169 Days Interval 70.0 to 278.0	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: mITT population included all randomized participants who received at least one treatment. As per planned analysis, efficacy data were collected and presented by overall randomized treatment assignment (either sham or adrabetadex). These two treatment arms (either sham or adrabetadex) combine data from Parts A and B of the study. Here, overall number of participants analyzed = participants evaluable for this outcome measure, and number analyzed = participants evaluable at specified time-point.

The TUG is a test of balance and risk for falls. This test measures the time taken by a participant to walk 3 meters starting from a sitting position and it ends when the participant is seated again.

Outcome measures

Outcome measures
Measure	Sham Control n=18 Participants Participants received sham control procedures once every 2 weeks for a total of 52 weeks.	Adrabetadex n=35 Participants Participants received lumbar IT infusions of adrabetadex once every 2 weeks for a total of 52 weeks.	Part A: Adrabetadex 1800 mg Participants received 4 lumbar IT infusions of adrabetadex 1800 mg once every 2 weeks.	Part A: Sham Control Participants received sham control procedures once every 2 weeks.	Part B: Adrabetadex 900 mg Participants received lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part B: Sham Control Participants received sham control procedures once every 2 weeks.
Parts A/B: Change From Baseline in the Timed Up and Go (TUG) Test at Week 52 Baseline	18.04 seconds Standard Deviation 19.000	16.40 seconds Standard Deviation 13.218	—	—	—	—
Parts A/B: Change From Baseline in the Timed Up and Go (TUG) Test at Week 52 Change from Baseline at Week 52	0.86 seconds Standard Deviation 19.232	2.70 seconds Standard Deviation 9.633	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, Week 52

The 9-Hole Peg Test is a brief, standardized, quantitative test of upper extremity function. The participant picks up 9 pegs puts them in a block containing nine empty holes, and, once they are in the holes, removes them again as quickly as possible one at a time. The total time to complete the task is recorded.

Outcome measures

Outcome measures
Measure	Sham Control n=18 Participants Participants received sham control procedures once every 2 weeks for a total of 52 weeks.	Adrabetadex n=38 Participants Participants received lumbar IT infusions of adrabetadex once every 2 weeks for a total of 52 weeks.	Part A: Adrabetadex 1800 mg Participants received 4 lumbar IT infusions of adrabetadex 1800 mg once every 2 weeks.	Part A: Sham Control Participants received sham control procedures once every 2 weeks.	Part B: Adrabetadex 900 mg Participants received lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part B: Sham Control Participants received sham control procedures once every 2 weeks.
Parts A/B: Change From Baseline in the 9-Hole Peg Test at Week 52	-1.49 seconds Standard Deviation 15.958	-1.79 seconds Standard Deviation 34.760	—	—	—	—

SECONDARY outcome

Timeframe: Baseline up to Week 52

Population: Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).

A TEAE is defined as an adverse event (AE) with onset on or after start of study Drug. An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Outcome measures

Outcome measures
Measure	Sham Control n=3 Participants Participants received sham control procedures once every 2 weeks for a total of 52 weeks.	Adrabetadex n=3 Participants Participants received lumbar IT infusions of adrabetadex once every 2 weeks for a total of 52 weeks.	Part A: Adrabetadex 1800 mg n=3 Participants Participants received 4 lumbar IT infusions of adrabetadex 1800 mg once every 2 weeks.	Part A: Sham Control n=3 Participants Participants received sham control procedures once every 2 weeks.	Part B: Adrabetadex 900 mg n=29 Participants Participants received lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part B: Sham Control n=15 Participants Participants received sham control procedures once every 2 weeks.
Parts A/B: Number of Participants With Treatment Emergent Adverse Events (TEAEs)	3 Participants	3 Participants	3 Participants	3 Participants	28 Participants	14 Participants

SECONDARY outcome

Timeframe: Baseline, Week 52

Outcome measures

Outcome measures
Measure	Sham Control n=14 Participants Participants received sham control procedures once every 2 weeks for a total of 52 weeks.	Adrabetadex n=34 Participants Participants received lumbar IT infusions of adrabetadex once every 2 weeks for a total of 52 weeks.	Part A: Adrabetadex 1800 mg Participants received 4 lumbar IT infusions of adrabetadex 1800 mg once every 2 weeks.	Part A: Sham Control Participants received sham control procedures once every 2 weeks.	Part B: Adrabetadex 900 mg Participants received lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part B: Sham Control Participants received sham control procedures once every 2 weeks.
Parts A/B: Change From Baseline to Week 52 in Mean Annualized Rate of Change (Slope) of NPC-SS Composite Score	-0.05 score on NPC-SS scale/year Standard Deviation 1.640	0.08 score on NPC-SS scale/year Standard Deviation 2.441	—	—	—	—

Adverse Events

Part A: Adrabetadex 900 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A: Adrabetadex 1200 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part A: Adrabetadex 1800 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Part A: Sham Control

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Part B: Adrabetadex 900 mg

Serious events: 16 serious events

Other events: 28 other events

Deaths: 0 deaths

Part B: Sham Control

Serious events: 3 serious events

Other events: 14 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Adrabetadex 900 mg n=3 participants at risk Participants received 4 lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part A: Adrabetadex 1200 mg n=3 participants at risk Participants received 4 lumbar IT infusions of adrabetadex 1200 mg once every 2 weeks.	Part A: Adrabetadex 1800 mg n=3 participants at risk Participants received 4 lumbar IT infusions of adrabetadex 1800 mg once every 2 weeks.	Part A: Sham Control n=3 participants at risk Participants received sham control procedures once every 2 weeks.	Part B: Adrabetadex 900 mg n=29 participants at risk Participants received lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part B: Sham Control n=15 participants at risk Participants received sham control procedures once every 2 weeks.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Ear and labyrinth disorders Deafness	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	10.3% 3/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Ear and labyrinth disorders Deafness Neurosensory	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Ear and labyrinth disorders Hearing Impaired	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	10.3% 3/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Ear and labyrinth disorders Hypoacusis	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Ear and labyrinth disorders Vertigo	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Colitis	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
General disorders Abasia	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Appendicitis Perforated	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Croup Infectious	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Pneumonia	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Respiratory Syncytial Virus Infection	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Stoma Site Cellulitis	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Viral Infection	33.3% 1/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Cerebrospinal Fluid Leakage	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Dystonia	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Epilepsy	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Postictal Paralysis	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Seizure	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	10.3% 3/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Speech Disorder	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Syncope	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Psychiatric disorders Mutism	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Respiratory, thoracic and mediastinal disorders Lung Infiltration	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	10.3% 3/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Skin and subcutaneous tissue disorders Haemorrhage Subcutaneous	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).

Other adverse events

Other adverse events
Measure	Part A: Adrabetadex 900 mg n=3 participants at risk Participants received 4 lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part A: Adrabetadex 1200 mg n=3 participants at risk Participants received 4 lumbar IT infusions of adrabetadex 1200 mg once every 2 weeks.	Part A: Adrabetadex 1800 mg n=3 participants at risk Participants received 4 lumbar IT infusions of adrabetadex 1800 mg once every 2 weeks.	Part A: Sham Control n=3 participants at risk Participants received sham control procedures once every 2 weeks.	Part B: Adrabetadex 900 mg n=29 participants at risk Participants received lumbar IT infusions of adrabetadex 900 mg once every 2 weeks.	Part B: Sham Control n=15 participants at risk Participants received sham control procedures once every 2 weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Ear and labyrinth disorders Deafness	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.8% 4/29 • Number of events 13 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Ear and labyrinth disorders Dysacusis	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Ear and labyrinth disorders Ear Pain	66.7% 2/3 • Number of events 7 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Ear and labyrinth disorders Hearing Impaired	66.7% 2/3 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 5 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	27.6% 8/29 • Number of events 18 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	40.0% 6/15 • Number of events 11 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Ear and labyrinth disorders Hypoacusis	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	66.7% 2/3 • Number of events 5 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	34.5% 10/29 • Number of events 27 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Ear and labyrinth disorders Tinnitus	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	17.2% 5/29 • Number of events 11 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Endocrine disorders Early Menarche	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Eye disorders Chalazion	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Eye disorders Diplopia	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Eye disorders Eye Inflammation	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Eye disorders Eye Swelling	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Eye disorders Eyelid Haematoma	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Abdominal Discomfort	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Abdominal Pain	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Constipation	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	10.3% 3/29 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	31.0% 9/29 • Number of events 16 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 8 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Dysphagia	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.8% 4/29 • Number of events 7 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	26.7% 4/15 • Number of events 7 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Faecal Incontinence	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	10.3% 3/29 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.3% 2/15 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Faeces Discoloured	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Food Poisoning	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Gastritis	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Malpositioned Teeth	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Nausea	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 5 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	66.7% 2/3 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	27.6% 8/29 • Number of events 19 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Oral Pain	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Salivary Hypersecretion	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.3% 2/15 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Toothache	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Gastrointestinal disorders Vomiting	66.7% 2/3 • Number of events 6 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	100.0% 3/3 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	51.7% 15/29 • Number of events 35 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.3% 2/15 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
General disorders Asthenia	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	20.7% 6/29 • Number of events 14 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
General disorders Facial Pain	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
General disorders Fatigue	66.7% 2/3 • Number of events 8 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	66.7% 2/3 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	66.7% 2/3 • Number of events 7 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	41.4% 12/29 • Number of events 29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.3% 2/15 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
General disorders Gait Disturbance	33.3% 1/3 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	100.0% 3/3 • Number of events 10 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	37.9% 11/29 • Number of events 47 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.3% 2/15 • Number of events 6 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
General disorders Injection Site Pain	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
General disorders Injection Site Reaction	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 6 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
General disorders Pain	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
General disorders Pyrexia	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	41.4% 12/29 • Number of events 23 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	20.0% 3/15 • Number of events 7 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Immune system disorders Drug Hypersensitivity	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Immune system disorders Hypersensitivity	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.3% 2/15 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Acute Tonsillitis	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Bronchitis	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.3% 2/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Conjunctivitis	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.3% 2/15 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Gastroenteritis	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	10.3% 3/29 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Hordeolum	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Impetigo	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Lower Respiratory Tract Infection	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Nasopharyngitis	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	10.3% 3/29 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.3% 2/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Otitis Externa	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Otitis Media	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Pharyngitis	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Respiratory Tract Infection	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Rhinitis	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	10.3% 3/29 • Number of events 7 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	20.0% 3/15 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Tinea Manuum	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	10.3% 3/29 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	20.0% 3/15 • Number of events 9 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Infections and infestations Urinary Tract Infection	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Injury, poisoning and procedural complications Animal Bite	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	17.2% 5/29 • Number of events 19 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.3% 2/15 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Injury, poisoning and procedural complications Eye Contusion	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	34.5% 10/29 • Number of events 63 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 10 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Injury, poisoning and procedural complications Foot Fracture	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Injury, poisoning and procedural complications Head Injury	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Injury, poisoning and procedural complications Laceration	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Injury, poisoning and procedural complications Ligament Sprain	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Injury, poisoning and procedural complications Lip Injury	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Injury, poisoning and procedural complications Procedural Headache	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	17.2% 5/29 • Number of events 8 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Injury, poisoning and procedural complications Procedural Pain	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 6 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Injury, poisoning and procedural complications Procedural Vomiting	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Injury, poisoning and procedural complications Skin Abrasion	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	10.3% 3/29 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Injury, poisoning and procedural complications Tooth Fracture	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Investigations Heart Rate Increased	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Investigations Platelet Count Decreased	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Investigations Tympanometry Abnormal	33.3% 1/3 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Investigations Weight Increased	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.3% 2/15 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Metabolism and nutrition disorders Decreased Appetite	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	100.0% 3/3 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Metabolism and nutrition disorders Feeding Disorder	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Metabolism and nutrition disorders Obesity	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Musculoskeletal and connective tissue disorders Back Pain	33.3% 1/3 • Number of events 6 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	66.7% 2/3 • Number of events 7 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 5 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	66.7% 2/3 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	48.3% 14/29 • Number of events 68 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Musculoskeletal and connective tissue disorders Joint Stiffness	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Musculoskeletal and connective tissue disorders Muscle Spasms	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Musculoskeletal and connective tissue disorders Muscular Weakness	66.7% 2/3 • Number of events 8 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	10.3% 3/29 • Number of events 9 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Musculoskeletal and connective tissue disorders Musculoskeletal Stiffness	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	10.3% 3/29 • Number of events 8 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Musculoskeletal and connective tissue disorders Myalgia	33.3% 1/3 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Musculoskeletal and connective tissue disorders Pain In Extremity	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	17.2% 5/29 • Number of events 14 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Altered State Of Consciousness	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Aphasia	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Ataxia	33.3% 1/3 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	100.0% 3/3 • Number of events 11 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	24.1% 7/29 • Number of events 34 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.3% 2/15 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Balance Disorder	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	10.3% 3/29 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Cataplexy	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Cerebellar Syndrome	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Cognitive Disorder	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Disturbance In Attention	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.3% 2/15 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Dizziness	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	66.7% 2/3 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	10.3% 3/29 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Dysarthria	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.8% 4/29 • Number of events 14 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Dyskinesia	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Epilepsy	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	20.0% 3/15 • Number of events 8 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Fine Motor Skill Dysfunction	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Headache	33.3% 1/3 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 9 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	31.0% 9/29 • Number of events 65 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Hypersomnia	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Hyporesponsive To Stimuli	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Language Disorder	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Lethargy	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Memory Impairment	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Motor Dysfunction	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Muscle Spasticity	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Nervous System Disorder	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Paraesthesia	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Seizure	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	20.7% 6/29 • Number of events 10 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Somnolence	33.3% 1/3 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	66.7% 2/3 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	10.3% 3/29 • Number of events 33 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Tremor	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.3% 2/15 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Nervous system disorders Viith Nerve Paralysis	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Psychiatric disorders Aggression	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Psychiatric disorders Agitation	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	66.7% 2/3 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 6 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Psychiatric disorders Anhedonia	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Psychiatric disorders Anxiety	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Psychiatric disorders Decreased Eye Contact	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Psychiatric disorders Depression	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Psychiatric disorders Emotional Distress	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Psychiatric disorders Hallucination	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Psychiatric disorders Insomnia	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	10.3% 3/29 • Number of events 6 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Psychiatric disorders Irritability	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	10.3% 3/29 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Psychiatric disorders Mania	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Psychiatric disorders Personality Change	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Psychiatric disorders Psychotic Disorder	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Psychiatric disorders Staring	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.3% 2/15 • Number of events 4 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Psychiatric disorders Stereotypy	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Renal and urinary disorders Urinary Incontinence	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	17.2% 5/29 • Number of events 11 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	20.7% 6/29 • Number of events 13 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	26.7% 4/15 • Number of events 8 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	66.7% 2/3 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	17.2% 5/29 • Number of events 20 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Respiratory, thoracic and mediastinal disorders Laryngeal Inflammation	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Respiratory, thoracic and mediastinal disorders Laryngeal Obstruction	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Respiratory, thoracic and mediastinal disorders Lower Respiratory Tract Congestion	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Respiratory, thoracic and mediastinal disorders Lung Infiltration	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Respiratory, thoracic and mediastinal disorders Nasal Congestion	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.3% 2/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	10.3% 3/29 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Respiratory, thoracic and mediastinal disorders Pneumonia Aspiration	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Skin and subcutaneous tissue disorders Dermatitis Acneiform	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	13.3% 2/15 • Number of events 30 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Skin and subcutaneous tissue disorders Night Sweats	33.3% 1/3 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Skin and subcutaneous tissue disorders Skin Reaction	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/29 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.7% 1/15 • Number of events 1 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Vascular disorders Flushing	33.3% 1/3 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	3.4% 1/29 • Number of events 3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).
Vascular disorders Hypotension	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/3 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	6.9% 2/29 • Number of events 2 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).	0.00% 0/15 • Baseline up to Week 52 Safety population was defined as all randomized participants who received at least 1 procedure (adrabetadex infusion via LP or sham).

Additional Information

Executive Vice President, Regulatory Affairs

Mandos, LLC

Phone: 619-905-0489

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER