Trial Outcomes & Findings for Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults (NCT NCT02610868)

Last Updated: 2021-07-13

Results Overview

TEAEs Related to Study Medication include TEAEs classified as Possibly, Probably and Definitely Related. Treatment Session (TS)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

187 participants

Primary outcome timeframe

Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1

Results posted on

2021-07-13

Participant Flow

Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed.

All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).

Participant milestones

Participant milestones
Measure	MYOBLOC: 3500U After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments.
MYOBLOC: Treatment Session 1 STARTED	187
MYOBLOC: Treatment Session 1 COMPLETED	180
MYOBLOC: Treatment Session 1 NOT COMPLETED	7
MYOBLOC: Treatment Session 2 STARTED	177
MYOBLOC: Treatment Session 2 COMPLETED	165
MYOBLOC: Treatment Session 2 NOT COMPLETED	12
MYOBLOC: Treatment Session 3 STARTED	50
MYOBLOC: Treatment Session 3 COMPLETED	43
MYOBLOC: Treatment Session 3 NOT COMPLETED	7
MYOBLOC: Treatment Session 4 STARTED	24
MYOBLOC: Treatment Session 4 COMPLETED	22
MYOBLOC: Treatment Session 4 NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open-Label and Single-Arm Study of MYOBLOC® in the Treatment of Troublesome Sialorrhea in Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MYOBLOC n=187 Participants MYOBLOC: After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments via injections into the submandibular and parotid glands. Subjects will undergo safety and effectiveness assessments at Weeks 4, 8, 13 for Treatment Session 1; Weeks 4, 13 for Treatment Sessions 2-4. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	85 Participants n=5 Participants
Age, Categorical >=65 years	102 Participants n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants
Sex: Female, Male Male	129 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	175 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	68 participants n=5 Participants
Region of Enrollment Ukraine	80 participants n=5 Participants
Region of Enrollment Belarus	39 participants n=5 Participants
Unstimulated Salivary Flow Rate (USFR)	0.6322 g/minute STANDARD_DEVIATION 0.4918 • n=5 Participants
Clinical Global Impression of Severity (CGI-S)	4.4 units on a scale (1-7) STANDARD_DEVIATION 0.94 • n=5 Participants
Patient Global Impression of Severity (PGI-S)	5.3 units on a scale (1-7) STANDARD_DEVIATION 1.2 • n=5 Participants

PRIMARY outcome

Timeframe: Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1

Population: Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U or 3000 U).

TEAEs Related to Study Medication include TEAEs classified as Possibly, Probably and Definitely Related. Treatment Session (TS)

Outcome measures

Outcome measures
Measure	Treatment Session 1 n=187 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2 n=177 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 3 n=50 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 4 n=24 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2: Week 13 Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.	Treatment Session 3: Week 4 Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 3: Week 13 Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 4: Week 4 Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.	Treatment Session 4: Week 13 Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.
Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) Serious TEAEs	7 participants	14 participants	3 participants	2 participants	—	—	—	—	—
Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) Severe TEAEs	5 participants	8 participants	2 participants	2 participants	—	—	—	—	—
Occurrence, Seriousness, Severity, and Causality Assessment of Treatment Emergent Adverse Events (TEAE) TEAEs Related to Study Medication	42 participants	26 participants	4 participants	2 participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1

Treatment Session (TS) AESI includes: Aspiration, Aspirational pneumonia, Choking and Dysphagia.

Outcome measures

Outcome measures
Measure	Treatment Session 1 n=187 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2 n=177 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 3 n=50 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 4 n=24 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2: Week 13 Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.	Treatment Session 3: Week 4 Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 3: Week 13 Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 4: Week 4 Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.	Treatment Session 4: Week 13 Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.
Occurrence of Adverse Events of Special Interest (AESI) Dysphagia	4 participants	0 participants	0 participants	0 participants	—	—	—	—	—
Occurrence of Adverse Events of Special Interest (AESI) Aspiration	0 participants	1 participants	0 participants	0 participants	—	—	—	—	—
Occurrence of Adverse Events of Special Interest (AESI) Aspirational pneumonia	0 participants	1 participants	0 participants	0 participants	—	—	—	—	—
Occurrence of Adverse Events of Special Interest (AESI) Choking	0 participants	0 participants	0 participants	0 participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13

Participants Analyzed does not match the Participant Flow because one participant discontinued prior to the first post-injection visit. Per protocol participants were only required to complete two treatment sessions with a maximum of 4 treatment sessions allowed. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).

Outcome measures

Outcome measures
Measure	Treatment Session 1 n=186 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2 n=183 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 3 n=181 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 4 n=175 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2: Week 13 n=166 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.	Treatment Session 3: Week 4 n=49 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 3: Week 13 n=45 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 4: Week 4 n=24 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.	Treatment Session 4: Week 13 n=23 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.
Columbia Suicide Rating Scale (C-SSRS): Suicidal Ideation, Behavior Scores and Intensity Scores Suicidal Ideation	2 participants	2 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants
Columbia Suicide Rating Scale (C-SSRS): Suicidal Ideation, Behavior Scores and Intensity Scores Suicidal Behavior	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Visits at Weeks 4 and 13 combined for each TS; including Visit at Week 8 for TS1

Treatment Session (TS)

Outcome measures

Outcome measures
Measure	Treatment Session 1 n=187 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2 n=177 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 3 n=50 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 4 n=24 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2: Week 13 Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.	Treatment Session 3: Week 4 Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 3: Week 13 Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 4: Week 4 Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.	Treatment Session 4: Week 13 Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.
Occurrence of Dental Adverse Events	27 participants	23 participants	8 participants	2 participants	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13

For Treatment Sessions 2-4, the change from baseline is calculated using the Week 13 value from the previous Treatment Session as the new baseline. Week 8 was only assessed in Treatment Session 1. Treatment Session (TS) Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit.

Outcome measures

Outcome measures
Measure	Treatment Session 1 n=185 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2 n=183 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 3 n=181 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 4 n=174 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2: Week 13 n=166 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.	Treatment Session 3: Week 4 n=49 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 3: Week 13 n=45 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 4: Week 4 n=24 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.	Treatment Session 4: Week 13 n=23 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.
Change From Baseline in Unstimulated Salivary Flow Rate (USFR): Treatment Sessions 1-4	-0.3424 g/minute Standard Deviation 0.3685	-0.2771 g/minute Standard Deviation 0.3144	-0.1357 g/minute Standard Deviation 0.2888	-0.2272 g/minute Standard Deviation 0.2668	-0.0560 g/minute Standard Deviation 0.2067	-0.1797 g/minute Standard Deviation 0.1975	-0.0547 g/minute Standard Deviation 0.2269	-0.1592 g/minute Standard Deviation 0.2305	-0.0335 g/minute Standard Deviation 0.1378

SECONDARY outcome

Timeframe: Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13

CGI-S will be used to record the severity of illness (sialorrhea) on a 7-point scale ranging from a score of 1, "normal" to a score of 7, "among the most extremely ill patients". Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.

Outcome measures

Outcome measures
Measure	Treatment Session 1 n=186 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2 n=183 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 3 n=181 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 4 n=175 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2: Week 13 n=167 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.	Treatment Session 3: Week 4 n=49 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 3: Week 13 n=45 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 4: Week 4 n=24 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.	Treatment Session 4: Week 13 n=23 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.
Change From Baseline in Clinical Global Impression of Severity (CGI-S)	-1.7 units on a scale Standard Deviation 1.26	-1.5 units on a scale Standard Deviation 1.22	-0.9 units on a scale Standard Deviation 1.03	-0.8 units on a scale Standard Deviation 1.12	-0.1 units on a scale Standard Deviation 0.99	-0.9 units on a scale Standard Deviation 1.13	-0.2 units on a scale Standard Deviation 0.90	-0.9 units on a scale Standard Deviation 0.95	-0.3 units on a scale Standard Deviation 1.02

SECONDARY outcome

Timeframe: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13

CGI-C will be used to record change or improvement of illness (sialorrhea) on a 7-point scale ranging from a score of 1, "very much improved" to a score of 7, "very much worse". Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. Treatment Session (TS)

Outcome measures

Outcome measures
Measure	Treatment Session 1 n=186 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2 n=183 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 3 n=181 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 4 n=175 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2: Week 13 n=167 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.	Treatment Session 3: Week 4 n=49 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 3: Week 13 n=45 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 4: Week 4 n=24 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.	Treatment Session 4: Week 13 n=23 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.
Clinical Global Impression of Change (CGI-C)	2.3 units on a scale Standard Deviation 0.94	2.4 units on a scale Standard Deviation 1.07	3.0 units on a scale Standard Deviation 1.16	2.4 units on a scale Standard Deviation 1.04	3.1 units on a scale Standard Deviation 1.34	2.4 units on a scale Standard Deviation 0.94	3.0 units on a scale Standard Deviation 1.06	2.5 units on a scale Standard Deviation 0.93	2.8 units on a scale Standard Deviation 0.94

SECONDARY outcome

Timeframe: Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13

The DFSS will be used to assess the frequency and severity of drooling on a 5-point scale ranging from a score of 1, dry never drools to a score of 5, profuse clothing hands tray objects become wet. Drooling frequency will be assessed on a 4-point scale ranging from a score of 1, never drools to a score of 4, constantly drools. Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit. The severity score and frequency score are summed together to create the DFSS total score (range 2-9). A decrease from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Treatment Session 1 n=186 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2 n=783 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 3 n=181 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 4 n=175 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2: Week 13 n=167 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.	Treatment Session 3: Week 4 n=49 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 3: Week 13 n=45 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 4: Week 4 n=24 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.	Treatment Session 4: Week 13 n=23 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.
Change From Baseline in Drooling Frequency and Severity Scale Performed by Trained Assessor (DFSS-I)	-2.3 units on a scale Standard Deviation 1.53	-2.0 units on a scale Standard Deviation 1.52	-1.2 units on a scale Standard Deviation 1.37	-1.2 units on a scale Standard Deviation 1.52	-0.2 units on a scale Standard Deviation 1.30	-1.1 units on a scale Standard Deviation 1.36	0.0 units on a scale Standard Deviation 1.33	-1.5 units on a scale Standard Deviation 1.44	-0.3 units on a scale Standard Deviation 0.71

SECONDARY outcome

Timeframe: Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13

The DFSS will be used to assess the frequency and severity of drooling on a 5-point scale ranging from a score of 1, dry never drools to a score of 5, profuse clothing hands tray objects become wet. Drooling frequency will be assessed on a 4-point scale ranging from a score of 1, never drools to a score of 4, constantly drools. Treatment Session (TS) Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit. The severity score and frequency score are summed together to create the DFSS total score (range 2 -9). A decrease from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Treatment Session 1 n=184 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2 n=182 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 3 n=177 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 4 n=170 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2: Week 13 n=162 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.	Treatment Session 3: Week 4 n=48 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 3: Week 13 n=43 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 4: Week 4 n=23 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.	Treatment Session 4: Week 13 n=22 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.
Change From Baseline in Drooling Frequency and Severity Scale Performed by Subject (DFSS-S)	-1.4 units on a scale Standard Deviation 1.35	-1.7 units on a scale Standard Deviation 1.58	-1.0 units on a scale Standard Deviation 1.49	-0.7 units on a scale Standard Deviation 0.90	-0.3 units on a scale Standard Deviation 0.98	-0.4 units on a scale Standard Deviation 0.64	0.0 units on a scale Standard Deviation 1.00	-0.4 units on a scale Standard Deviation 1.03	-0.2 units on a scale Standard Deviation 1.37

SECONDARY outcome

Timeframe: Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13

The PGI-S scale will be used by the subject to rate the severity of his/her illness (sialorrhea) on an 7-point scale ranging from a score of 1, "normal" to a score of 7, "among the most extremely ill". Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.

Outcome measures

Outcome measures
Measure	Treatment Session 1 n=186 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2 n=183 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 3 n=181 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 4 n=174 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2: Week 13 n=167 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.	Treatment Session 3: Week 4 n=49 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 3: Week 13 n=45 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 4: Week 4 n=24 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.	Treatment Session 4: Week 13 n=23 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.
Change From Baseline in Patient Global Impression of Severity (PGI-S)	-1.59 units on a scale Standard Deviation 1.548	-1.41 units on a scale Standard Deviation 1.461	-0.80 units on a scale Standard Deviation 1.364	-0.78 units on a scale Standard Deviation 1.303	-0.07 units on a scale Standard Deviation 1.245	-0.94 units on a scale Standard Deviation 1.248	0.04 units on a scale Standard Deviation 1.242	-1.38 units on a scale Standard Deviation 1.279	-0.26 units on a scale Standard Deviation 1.251

SECONDARY outcome

Timeframe: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13

The PGI-C scale will be used by the subject to rate the change in symptoms of his/her illness (sialorrhea) on an 7-point scale ranging from a score of 1, "very much improved" to a score of 7, "very much worse". Treatment Session (TS) Participants Analyzed does not match the Participant Flow because participant discontinued prior to the first post-injection visit.

Outcome measures

Outcome measures
Measure	Treatment Session 1 n=186 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2 n=183 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 3 n=181 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 4 n=174 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2: Week 13 n=167 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.	Treatment Session 3: Week 4 n=49 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 3: Week 13 n=45 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 4: Week 4 n=24 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.	Treatment Session 4: Week 13 n=23 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.
Patient Global Impression of Change (PGI-C)	2.5 units on a scale Standard Deviation 1.07	2.7 units on a scale Standard Deviation 1.08	3.0 units on a scale Standard Deviation 1.13	2.6 units on a scale Standard Deviation 1.06	3.2 units on a scale Standard Deviation 1.28	2.7 units on a scale Standard Deviation 0.95	3.2 units on a scale Standard Deviation 1.10	2.5 units on a scale Standard Deviation 0.72	3.4 units on a scale Standard Deviation 0.72

SECONDARY outcome

Timeframe: Baseline (Day 1) of each TS to the following: TS1 Visits at Weeks 4, 8, 13; TS2-4 Visits at Weeks 4, 13

The DIS is a 10-item questionnaire with each item rated by the subject to evaluate the impact of sialorrhea on daily activities (e.g., speech, social activities). Treatment Session (TS) Participants Analyzed does not match the Participant Flow because patient data was not always captured for each endpoint at every visit. Subject is requested to compare their current status to their last study visit using a 4-point scale ranging from a score of 1, not at all to a score of 4, very much. The DIS total score ranges from 10 to 40. A negative change from baseline indicates a positive clinical outcome.

Outcome measures

Outcome measures
Measure	Treatment Session 1 n=185 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2 n=183 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 3 n=181 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 4 n=175 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments.	Treatment Session 2: Week 13 n=167 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13.	Treatment Session 3: Week 4 n=49 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 3: Week 13 n=45 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13.	Treatment Session 4: Week 4 n=24 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.	Treatment Session 4: Week 13 n=23 Participants Subjects received single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13.
Change From Baseline in Drooling Impact Score (DIS)	-5.2 units on a scale Standard Deviation 5.33	-5.4 units on a scale Standard Deviation 5.16	-3.4 units on a scale Standard Deviation 4.97	-2.5 units on a scale Standard Deviation 4.17	0.3 units on a scale Standard Deviation 3.94	-2.8 units on a scale Standard Deviation 3.39	-0.1 units on a scale Standard Deviation 2.11	-3.6 units on a scale Standard Deviation 3.10	-0.5 units on a scale Standard Deviation 2.57

Adverse Events

MYOBLOC: Treatment Session 1

Serious events: 9 serious events

Other events: 44 other events

Deaths: 1 deaths

MYOBLOC: Treatment Session 2

Serious events: 18 serious events

Other events: 34 other events

Deaths: 4 deaths

MYOBLOC: Treatment Session 3

Serious events: 4 serious events

Other events: 7 other events

Deaths: 2 deaths

MYOBLOC: Treatment Session 4

Serious events: 2 serious events

Other events: 4 other events

Deaths: 1 deaths

ALL MYOBLOC: Treatment Sessions 1-4

Serious events: 33 serious events

Other events: 73 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	MYOBLOC: Treatment Session 1 n=187 participants at risk After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).	MYOBLOC: Treatment Session 2 n=177 participants at risk After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).	MYOBLOC: Treatment Session 3 n=50 participants at risk After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).	MYOBLOC: Treatment Session 4 n=24 participants at risk After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).	ALL MYOBLOC: Treatment Sessions 1-4 n=187 participants at risk After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments at Weeks 4, 8, 13 for Treatment Session 1, Weeks 4 and 13 for Treatment Sessions 2-4. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).
Cardiac disorders Angina pectoris	1.1% 2/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	1.1% 2/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Cardiac disorders Atrial fibrillation	0.00% 0/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.56% 1/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Cardiac disorders Coronary artery disease	0.00% 0/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.56% 1/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Gastrointestinal disorders Large intestinal obstruction	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Injury, poisoning and procedural complications Post procedural compication	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Injury, poisoning and procedural complications Contusion	0.00% 0/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.56% 1/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Injury, poisoning and procedural complications Fall	0.00% 0/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.56% 1/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.56% 1/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.56% 1/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	2.0% 1/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	1.6% 3/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.56% 1/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	4.2% 1/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	1.1% 2/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Nervous system disorders Multiple system atrophy	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Nervous system disorders Amyotrophic lateral sclerosis	0.00% 0/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	1.1% 2/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	2.0% 1/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	4.2% 1/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	2.1% 4/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Nervous system disorders Freezing phenomenon	0.00% 0/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.56% 1/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Psychiatric disorders Delirium	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Psychiatric disorders Mental status changes	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.56% 1/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.56% 1/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Infections and infestations Pneumonia	0.00% 0/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	1.1% 2/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	2.0% 1/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	1.6% 3/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Infections and infestations Urosepsis	0.00% 0/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.56% 1/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Metabolism and nutrition disorders Dehydration	0.00% 0/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.56% 1/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Metabolism and nutrition disorders Malnutrition	0.00% 0/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	2.0% 1/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.56% 1/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.56% 1/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.53% 1/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.

Other adverse events

Other adverse events
Measure	MYOBLOC: Treatment Session 1 n=187 participants at risk After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 1 at Weeks 4, 8, 13. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).	MYOBLOC: Treatment Session 2 n=177 participants at risk After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 2 at Weeks 4 and 13. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).	MYOBLOC: Treatment Session 3 n=50 participants at risk After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 3 at Weeks 4 and 13. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).	MYOBLOC: Treatment Session 4 n=24 participants at risk After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments for Treatment Session 4 at Weeks 4 and 13. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).	ALL MYOBLOC: Treatment Sessions 1-4 n=187 participants at risk After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments. Subjects will undergo safety and effectiveness assessments at Weeks 4, 8, 13 for Treatment Session 1, Weeks 4 and 13 for Treatment Sessions 2-4. All subjects received 3500 U doses except for 13 subjects who had decreased doses at Treatment Session 2 and/or 3 (2500 U to 3000 U).
Gastrointestinal disorders Dental caries	7.0% 13/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	9.6% 17/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	12.0% 6/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	8.3% 2/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	17.1% 32/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Gastrointestinal disorders Dry mouth	15.5% 29/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	5.6% 10/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	2.0% 1/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	17.6% 33/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.
Nervous system disorders Amyotrophic lateral sclerosis	1.1% 2/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	4.0% 7/177 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	0.00% 0/50 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	8.3% 2/24 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.	4.3% 8/187 • through study completion, up to 1 year Systematic Assessment: Office visits were conducted on Weeks 4, 8, 13 for Treatment Session 1 and Weeks 4 and 13 for Treatment Sessions 2, 3, 4.

Additional Information

Regulatory Affairs Specialist

Solstice Neurosciences

Phone: 502-815-8148

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place