Trial Outcomes & Findings for Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (NCT NCT02087150)

NCT ID: NCT02087150

Last Updated: 2024-07-12

Results Overview

The primary efficacy analysis compares randomized subjects with tympanogram normalization (Types B or C normalized to Type A) in all indicated ears at 6 weeks in the investigational arm versus the control arm. Per protocol, tympanogram types are defined as follows: Type A: Peak compliance occurs between +50 and -100 daPa, with minimum peak height of 0.2ml. Indicates NORMAL middle ear function Type B: No sharp peak and a rounded line. Indicates ABNORMAL middle ear function Type C: Peak compliance occurs beyond -100 daPa. Indicates ABNORMAL middle ear function

Recruitment status

COMPLETED

Study phase

Target enrollment

323 participants

Primary outcome timeframe

6 Week Follow-Up Visit

Results posted on

2024-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	Lead-In Subjects enrolled in Lead-In Group	Randomized ETBC Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)	Randomized MM Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits
Overall Study STARTED	81	162	80
Overall Study Had a Lead-in or Randomized ETBC Proc	80	149	0
Overall Study Received a Crossover MM ETBC Procedure	0	0	70
Overall Study COMPLETED	71	128	69
Overall Study NOT COMPLETED	10	34	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Lead-In Subjects enrolled in Lead-In Group	Randomized ETBC Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)	Randomized MM Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits
Overall Study Death	0	1	0
Overall Study Lost to Follow-up	6	13	7
Overall Study Withdrawal by Subject	2	5	3
Overall Study Physician Decision	0	1	0
Overall Study Procedure not done	1	13	0
Overall Study F/U not completed w/in study window	0	0	1
Overall Study Other	1	0	0
Overall Study Pt moved out of town	0	1	0

Baseline Characteristics

Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lead-In n=81 Participants Subjects enrolled in Lead-In Group	Randomized ETBC n=162 Participants Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)	Randomized MM n=80 Participants Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits	Total n=323 Participants Total of all reporting groups
Age, Continuous	53.7 Years STANDARD_DEVIATION 14.1 • n=5 Participants	55.6 Years STANDARD_DEVIATION 14.3 • n=7 Participants	57.7 Years STANDARD_DEVIATION 13.4 • n=5 Participants	55.6 Years STANDARD_DEVIATION 14.1 • n=4 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	77 Participants n=7 Participants	48 Participants n=5 Participants	155 Participants n=4 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	85 Participants n=7 Participants	32 Participants n=5 Participants	168 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	9 Participants n=7 Participants	2 Participants n=5 Participants	12 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	80 Participants n=5 Participants	153 Participants n=7 Participants	78 Participants n=5 Participants	311 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	12 Participants n=7 Participants	8 Participants n=5 Participants	23 Participants n=4 Participants
Race (NIH/OMB) White	77 Participants n=5 Participants	147 Participants n=7 Participants	67 Participants n=5 Participants	291 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants

PRIMARY outcome

Timeframe: 6 Week Follow-Up Visit

Population: Primary Analysis Cohort (PAC): The PAC is defined as all randomized subjects who receive a study treatment for which they are randomized and have completed their primary analysis visits (i.e. completer analysis with baseline and 6 week tympanogram).

Outcome measures

Outcome measures
Measure	Randomized ETBC n=143 Participants Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)	Randomized MM n=72 Participants Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits
Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks	73 Participants	10 Participants

SECONDARY outcome

Timeframe: 6 Week Follow-Up Visit

The secondary efficacy endpoint will consist of comparison of subjects achieving at least a minimally important difference (MID) level improvement of 0.5 points on the ETDQ-7 at 6 weeks post-treatment in the investigational arm versus the proportion of subjects achieving at least an MID level improvement on the ETDQ-7 at 6 weeks post-randomization in the control arm The ETDQ-7 is a seven-item ETD specific validated quality of life survey. A mean item score of greater or equal to 2.1 indicates the presence of ETD.

Outcome measures

Outcome measures
Measure	Randomized ETBC n=143 Participants Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)	Randomized MM n=72 Participants Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits
Secondary Efficacy Endpoint: Number of Randomized Subjects With MID Improvement From Baseline of 0.5 Points or More at 6 Weeks	128 Participants	32 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12, 24, 52 Week Follow-Up

Population: Per-Protocol Cohort: All randomized subjects expect those who: • Did not complete a baseline or respective follow-up assessment for the time point under analysis • Did not receive the treatment for which they were randomized • Had any major protocol deviation(s)

Evaluation of subjects experiencing normalization of tympanometry at 12 weeks, 24 weeks, and 52 weeks post-treatment in the investigational arm and evaluation of subjects experiencing normalization of tympanometry at 12 weeks, 24 weeks, and 52 weeks post-randomization in the control arm. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.

Outcome measures

Outcome measures
Measure	Randomized ETBC n=149 Participants Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)	Randomized MM n=80 Participants Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits
Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks 12 Week Visit	64 Participants	7 Participants
Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks 24 Week Visit	78 Participants	5 Participants
Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks 52 Week Visit	71 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12,24,52 Week Follow-Up Visit

Evaluation of subjects achieving at least a MID level improvement of 0.5 points at 12 weeks, 24 weeks, and 52 weeks post-treatment in the investigational arm and evaluation of subjects achieving at least a MID level improvement at 12 weeks, 24 weeks, and 52 weeks post-randomization in the control arm. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.

Outcome measures

Outcome measures
Measure	Randomized ETBC n=149 Participants Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)	Randomized MM n=80 Participants Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits
Exploratory Endpoint: Number of Randomized Subjects With ETDQ-7 Improvement at 12, 24, 52 Weeks 12 Week Visit	118 Participants	9 Participants
Exploratory Endpoint: Number of Randomized Subjects With ETDQ-7 Improvement at 12, 24, 52 Weeks 24 Week Visit	123 Participants	5 Participants
Exploratory Endpoint: Number of Randomized Subjects With ETDQ-7 Improvement at 12, 24, 52 Weeks 52 Week Visit	111 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6,12,24,52 Week Follow-Up

Evaluation of subjects' work and activity impairment before and after treatment in both the investigational arm and the control arm. The Work Productivity and Activity Impairment (WPAI) questionnaire is a 6-question patient-reported general health assessment of productivity and activity impairment. WPAI results are expressed as the percentage of impairment from 0 to 100 where higher numbers indicate greater impairment or less productivity. Due to an error in the WPAI electronic data collection form, 2 questions were not visible to many subjects resulting in a significant amount of missing data for all scores except non-work activity impairment. Therefore, only the non-work activity impairment results are presented. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.

Outcome measures

Outcome measures
Measure	Randomized ETBC n=149 Participants Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)	Randomized MM n=80 Participants Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits
Exploratory Endpoint: WPAI at 6,12,24,52 Weeks Baseline	45.3 Percentage of Impairment Standard Deviation 32.8	50.4 Percentage of Impairment Standard Deviation 31.1
Exploratory Endpoint: WPAI at 6,12,24,52 Weeks 6 Week Visit	16.6 Percentage of Impairment Standard Deviation 23.6	47.1 Percentage of Impairment Standard Deviation 32.0
Exploratory Endpoint: WPAI at 6,12,24,52 Weeks 12 Week Visit	10.9 Percentage of Impairment Standard Deviation 16.1	38.2 Percentage of Impairment Standard Deviation 27.5
Exploratory Endpoint: WPAI at 6,12,24,52 Weeks 24 Week Visit	12.0 Percentage of Impairment Standard Deviation 19.5	33.8 Percentage of Impairment Standard Deviation 37.0
Exploratory Endpoint: WPAI at 6,12,24,52 Weeks 52 Week Visit	9.1 Percentage of Impairment Standard Deviation 18.2	17.5 Percentage of Impairment Standard Deviation 20.6

Adverse Events

Lead-In

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Randomized ETBC

Serious events: 5 serious events

Other events: 58 other events

Deaths: 1 deaths

Crossover MM

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

ALL ETBC

Serious events: 7 serious events

Other events: 108 other events

Deaths: 1 deaths

Randomized MM

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lead-In n=80 participants at risk Subjects enrolled in the Lead-in group and treated with the ETBC	Randomized ETBC n=149 participants at risk Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)	Crossover MM n=70 participants at risk Subjects enrolled and randomized to treatment with Medical Management (MM) only who crossed over to have treatment with the ETBC after the 6-week follow-up visit	ALL ETBC n=299 participants at risk All subjects in the lead-in phase, subjects randomized to the investigational arm who received treatment with the ETBC, and subjects in the control arm who crossed over to have treatment with the ETBC	Randomized MM n=80 participants at risk Subjects enrolled and randomized to treatment with Medical Management (MM) only
Cardiac disorders Coronary artery occlusion	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/299 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Cardiac disorders Myocardial infarction	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.3% 2/149 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 2/299 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
General disorders Non-cardiac chest pain	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Nervous system disorders Cerebrovascular accident	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Nervous system disorders Syncope	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Psychiatric disorders Bipolar I disorder	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.

Other adverse events

Other adverse events
Measure	Lead-In n=80 participants at risk Subjects enrolled in the Lead-in group and treated with the ETBC	Randomized ETBC n=149 participants at risk Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)	Crossover MM n=70 participants at risk Subjects enrolled and randomized to treatment with Medical Management (MM) only who crossed over to have treatment with the ETBC after the 6-week follow-up visit	ALL ETBC n=299 participants at risk All subjects in the lead-in phase, subjects randomized to the investigational arm who received treatment with the ETBC, and subjects in the control arm who crossed over to have treatment with the ETBC	Randomized MM n=80 participants at risk Subjects enrolled and randomized to treatment with Medical Management (MM) only
Nervous system disorders Dizziness	2.5% 2/80 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.0% 3/299 • Number of events 3 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Nervous system disorders Headache	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.3% 2/149 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 2/299 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Nervous system disorders Hypoaesthesia	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Nervous system disorders Paraesthesia	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Nervous system disorders Sinus headache	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Nervous system disorders Syncope	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.4% 1/70 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/299 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Respiratory, thoracic and mediastinal disorders Asthma	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	2.0% 3/149 • Number of events 3 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.0% 3/299 • Number of events 3 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Respiratory, thoracic and mediastinal disorders Epistaxis	3.8% 3/80 • Number of events 3 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.3% 4/299 • Number of events 4 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.5% 2/80 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.3% 2/149 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.3% 4/299 • Number of events 4 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Respiratory, thoracic and mediastinal disorders Reflux laryngitis	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Skin and subcutaneous tissue disorders Pruritis	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Skin and subcutaneous tissue disorders Rash	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Cardiac disorders Coronary artery disease	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/299 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Ear and labyrinth disorders Conductive deafness	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Ear and labyrinth disorders Deafness	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.3% 2/149 • Number of events 3 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 2/299 • Number of events 3 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Ear and labyrinth disorders Ear discomfort	2.5% 2/80 • Number of events 3 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.3% 2/149 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.3% 4/299 • Number of events 5 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Ear and labyrinth disorders Ear pain	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	2.7% 4/149 • Number of events 4 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.4% 1/70 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.7% 5/299 • Number of events 5 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Ear and labyrinth disorders Eustachian tube disorder	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Ear and labyrinth disorders Eustachian tube dysfunction	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	2.0% 3/149 • Number of events 4 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.0% 3/299 • Number of events 4 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Ear and labyrinth disorders Eustachian tube obstruction	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Ear and labyrinth disorders Eustachian tube patulous	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.3% 2/149 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 2/299 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Ear and labyrinth disorders Hypoacusis	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 2/299 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Ear and labyrinth disorders Middle ear effusion	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.3% 2/149 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	2.9% 2/70 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.3% 4/299 • Number of events 4 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Ear and labyrinth disorders Otorrhea	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Ear and labyrinth disorders Tinnitus	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.4% 1/70 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 2/299 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	2.7% 4/149 • Number of events 4 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.4% 1/70 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.7% 5/299 • Number of events 5 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Ear and labyrinth disorders Vertigo	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.3% 2/149 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.0% 3/299 • Number of events 3 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Ear and labyrinth disorders Tympanic membrane disorder	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.4% 1/70 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 2/299 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Gastrointestinal disorders Oesophageal spasm	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/299 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Gastrointestinal disorders Tooth impacted	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/299 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Gastrointestinal disorders Gastroesophageal reflux disease	2.5% 2/80 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.0% 3/299 • Number of events 3 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Gastrointestinal disorders Glossodynia	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Gastrointestinal disorders Inguinal hernia	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Gastrointestinal disorders Toothache	2.5% 2/80 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 2/299 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Gastrointestinal disorders Vomiting	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.4% 1/70 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
General disorders Adverse drug reaction	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/299 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
General disorders Effusion	1.2% 1/80 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
General disorders Facial pain	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
General disorders Oedema	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
General disorders Pyrexia	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
General disorders Sensation of foreign body	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Herpes zoster	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/299 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations tooth abscess	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/299 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/299 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Acute sinusitis	3.8% 3/80 • Number of events 3 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.3% 4/299 • Number of events 4 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Bronchitis	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	2.9% 2/70 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.3% 4/299 • Number of events 4 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Cellulitis	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Chronic sinusitis	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.4% 1/70 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 2/299 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Conjunctivitis infective	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Ear infection	1.2% 1/80 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.4% 1/70 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.0% 3/299 • Number of events 4 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Hordeolum	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.4% 1/70 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Infection	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Influenza	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Myringitis bullous	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Nasopharyngitis	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	4.3% 3/70 • Number of events 4 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.3% 4/299 • Number of events 5 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Otitis extrerna	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.3% 2/149 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.0% 3/299 • Number of events 3 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Otitis media	1.2% 1/80 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	2.7% 4/149 • Number of events 4 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.4% 1/70 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	2.0% 6/299 • Number of events 7 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Otitis media acute	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Otitis media chronic	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Pharyngitis	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Pharyngitis streptococcal	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Pneumonia	2.5% 2/80 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 2/299 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Sinusitis	2.5% 2/80 • Number of events 4 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	4.7% 7/149 • Number of events 8 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	5.7% 4/70 • Number of events 4 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	4.3% 13/299 • Number of events 16 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	2.5% 2/80 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Tonsillitis	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Infections and infestations Upper respiratory tract infection	6.2% 5/80 • Number of events 6 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	6.7% 10/149 • Number of events 11 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	8.6% 6/70 • Number of events 6 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	7.0% 21/299 • Number of events 23 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Injury, poisoning and procedural complications Deafness traumatic	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Injury, poisoning and procedural complications Joint injury	2.5% 2/80 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 2/299 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Injury, poisoning and procedural complications Laceration	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 2/299 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Injury, poisoning and procedural complications Ligament sprain	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Injury, poisoning and procedural complications Mucosal excoriation	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Investigations Blood potassium decreased	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.4% 1/70 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.4% 1/70 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Musculoskeletal and connective tissue disorders Myalgia	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Musculoskeletal and connective tissue disorders Pain in jaw	1.2% 1/80 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 2/299 • Number of events 2 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/149 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	1.4% 1/70 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.67% 1/149 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/70 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.33% 1/299 • Number of events 1 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.	0.00% 0/80 • Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.

Additional Information

Patricia Chen

Acclarent

Phone: 949-453-6408

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60