Trial Outcomes & Findings for SubQStim: A Post-market Study of Subcutaneous Nerve Stimulation in Failed Back Surgery Syndrome (FBSS) Patients (NCT NCT01711619)

Last Updated: 2018-10-22

Results Overview

Percentage of participants who responded to the treatment, where response was defined as ≥ 50% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 9-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable.

Recruitment status

TERMINATED

Study phase

Target enrollment

162 participants

Primary outcome timeframe

9 months

Results posted on

2018-10-22

Participant Flow

The first subject enrolled in the study on January 11, 2013. The last subject was enrolled on January 15, 2016 and all subject visits were stopped as of the study termination date of February 12, 2016.

Patients were considered enrolled in the study upon signing an Informed Consent Form. Enrolled subjects then completed additional assessments and were provided a diary to record ther back and leg pain intensity. Upon completion of the at-home diary, eligibility was reassessed based on pain scores. Eligible subjects were then randomized.

Participant milestones

Participant milestones
Measure	SQS+OMM Subcutaneous nerve stimulation (SQS) plus optimized medical management (OMM)	OMM Alone Optimized Medical Management alone (OMM)
Overall Study STARTED	56	60
Overall Study COMPLETED	38	36
Overall Study NOT COMPLETED	18	24

Reasons for withdrawal

Reasons for withdrawal
Measure	SQS+OMM Subcutaneous nerve stimulation (SQS) plus optimized medical management (OMM)	OMM Alone Optimized Medical Management alone (OMM)
Overall Study Early study termination	10	14
Overall Study Withdrawal by Subject	3	7
Overall Study Protocol Violation	2	3
Overall Study Adverse Event	2	0
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

SubQStim: A Post-market Study of Subcutaneous Nerve Stimulation in Failed Back Surgery Syndrome (FBSS) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SQS+OMM n=56 Participants Subcutaneous nerve stimulation (SQS) plus optimized medical management (OMM)	OMM Alone n=60 Participants Optimized Medical Management alone (OMM)	Total n=116 Participants Total of all reporting groups
Age, Continuous	50.9 years STANDARD_DEVIATION 10.9 • n=99 Participants	52.2 years STANDARD_DEVIATION 11.4 • n=107 Participants	51.6 years STANDARD_DEVIATION 11.1 • n=206 Participants
Sex: Female, Male Female	32 Participants n=99 Participants	34 Participants n=107 Participants	66 Participants n=206 Participants
Sex: Female, Male Male	24 Participants n=99 Participants	26 Participants n=107 Participants	50 Participants n=206 Participants
Pain intensity at baseline Back pain	68.8 units on a scale STANDARD_DEVIATION 13.4 • n=99 Participants	70.1 units on a scale STANDARD_DEVIATION 14.0 • n=107 Participants	69.5 units on a scale STANDARD_DEVIATION 13.7 • n=206 Participants
Pain intensity at baseline Leg pain	8.9 units on a scale STANDARD_DEVIATION 10.8 • n=99 Participants	6.8 units on a scale STANDARD_DEVIATION 11.5 • n=107 Participants	7.8 units on a scale STANDARD_DEVIATION 11.2 • n=206 Participants

PRIMARY outcome

Timeframe: 9 months

Population: The Intent-to-Treat patient set (ITT) consists of all subjects as they were randomized into the study. The As Treated consists of all patients of the ITT patient set, but excludes those with major protocol deviations; they are analysed according to last treatment received before the actual assessment, without replacement of missing data.

Outcome measures

Outcome measures
Measure	SQS+OMM n=56 Participants Subcutaneous nerve stimulation (SQS) plus optimized medical management (OMM)	OMM Alone n=60 Participants Optimized Medical Management alone (OMM)
Effectiveness of Treatment on Reduction of Back Pain Intensity Intent to treat	33.9 Percentage of responders Interval 21.5 to 46.3	1.7 Percentage of responders Interval 0.0 to 4.9
Effectiveness of Treatment on Reduction of Back Pain Intensity As treated	56.7 Percentage of responders Interval 38.9 to 74.4	2.9 Percentage of responders Interval 0.0 to 8.4

SECONDARY outcome

Timeframe: 6 and 9 months

Average change in back pain intensity from baseline to the 6 and 9-month follow-up visits. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable. A reduction in average pain score is indicated by a negative number.

Outcome measures

Outcome measures
Measure	SQS+OMM n=56 Participants Subcutaneous nerve stimulation (SQS) plus optimized medical management (OMM)	OMM Alone n=60 Participants Optimized Medical Management alone (OMM)
Average Change in Back Pain Intensity Intent to treat: Abs change in back pain at 6 mo	-33.7 units on a scale Standard Deviation 26.4	-0.6 units on a scale Standard Deviation 14.3
Average Change in Back Pain Intensity Intent to treat: Abs change in back pain at 9 mo	-33.3 units on a scale Standard Deviation 24.5	-2.7 units on a scale Standard Deviation 16.0
Average Change in Back Pain Intensity As treated: Absolute change in back pain at 6 mo	-35.0 units on a scale Standard Deviation 25.5	-2.9 units on a scale Standard Deviation 12.5
Average Change in Back Pain Intensity As treated:Absolute change in back pain at 9 mo	-35.9 units on a scale Standard Deviation 25.3	-4.1 units on a scale Standard Deviation 14.8

SECONDARY outcome

Timeframe: 6 months

Percentage of participants who responded to the treatment, where response was defined as ≥ 50% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 6-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable.

Outcome measures

Outcome measures
Measure	SQS+OMM n=56 Participants Subcutaneous nerve stimulation (SQS) plus optimized medical management (OMM)	OMM Alone n=60 Participants Optimized Medical Management alone (OMM)
Back Pain Responder Rate (≥50%) at 6 Months Intent to treat	26.8 Percentage of responders Interval 15.2 to 38.4	1.7 Percentage of responders Interval 0.0 to 4.9
Back Pain Responder Rate (≥50%) at 6 Months As treated	40.0 Percentage of responders Interval 22.5 to 57.5	2.9 Percentage of responders Interval 0.0 to 8.4

SECONDARY outcome

Timeframe: 9 months

Percentage of participants who responded to the treatment, where response was defined as ≥ 30% reduction in back pain intensity as measured by Visual Analog Scale from baseline to the 9-month follow-up visit. Pain intensity was measured by a 100 mm Visual Analog Scale, with 0 representing no pain and 100 representing the worst pain imaginable.

Outcome measures

Outcome measures
Measure	SQS+OMM n=56 Participants Subcutaneous nerve stimulation (SQS) plus optimized medical management (OMM)	OMM Alone n=60 Participants Optimized Medical Management alone (OMM)
Back Pain Responder Rate (≥30%) at 9 Months As treated	70.0 Percentage of responders Interval 53.6 to 86.4	11.4 Percentage of responders Interval 0.9 to 22.0
Back Pain Responder Rate (≥30%) at 9 Months Intent to treat	44.6 Percentage of responders Interval 31.6 to 57.7	5.0 Percentage of responders Interval 0.0 to 10.5

Adverse Events

SQS+OMM

Serious events: 19 serious events

Other events: 18 other events

Deaths: 0 deaths

OMM Alone

Serious events: 9 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Global Clinical Study Manager

Medtronic

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study Publication Committee manages and oversees publications generated from the study. The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor can require changes to the communication related to patentable and copyrightable material and can extend the embargo.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	SQS+OMM n=55 participants at risk Subcutaneous nerve stimulation (SQS) plus optimized medical management (OMM)	OMM Alone n=60 participants at risk Optimized Medical Management alone (OMM)
Cardiac disorders Cardiac disorder	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Cardiac disorders Pericarditis	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Eye disorders Cataract	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Gastrointestinal disorders Diaphragmatic hernia	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
General disorders Chest pain	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
General disorders Device stimulation issue	3.6% 2/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
General disorders Drug withdrawal syndrome	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
General disorders Implant site paraesthesia	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
General disorders Pain	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
General disorders Therapeutic product ineffective	3.6% 2/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Hepatobiliary disorders Cholecystitis acute	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Infections and infestations Implant site infection	3.6% 2/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Infections and infestations Skin infection	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Infections and infestations Staphylococcal infection	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Infections and infestations Urinary tract infection	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Injury, poisoning and procedural complications Alcohol poisoning	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Injury, poisoning and procedural complications Post procedural haemorrhage	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Investigations C-reactive protein abnormal	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Investigations White blood cell count increased	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Musculoskeletal and connective tissue disorders Back pain	3.6% 2/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Musculoskeletal and connective tissue disorders Fibromyalgia	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Musculoskeletal and connective tissue disorders Muscle contracture	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Musculoskeletal and connective tissue disorders Osteoarthritis	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer stage II	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Nervous system disorders Muscle contractions involuntary	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Psychiatric disorders Mental disorder	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Renal and urinary disorders Calculus urinary	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Surgical and medical procedures Drug detoxification	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Surgical and medical procedures Haemorrhoid operation	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.

Other adverse events
Measure	SQS+OMM n=55 participants at risk Subcutaneous nerve stimulation (SQS) plus optimized medical management (OMM)	OMM Alone n=60 participants at risk Optimized Medical Management alone (OMM)
Blood and lymphatic system disorders Lymphocytosis	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Cardiac disorders Tachycardia	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Ear and labyrinth disorders Tinnitus	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Ear and labyrinth disorders Vertigo	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Eye disorders Cataract	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Eye disorders Vitreous haemorrhage	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Gastrointestinal disorders Abdominal pain	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Gastrointestinal disorders Constipation	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	3.3% 2/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Gastrointestinal disorders Diarrhoea	3.6% 2/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	3.3% 2/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Gastrointestinal disorders Food poisoning	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Gastrointestinal disorders Gastric polyps	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Gastrointestinal disorders Oral lichen planus	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Gastrointestinal disorders Vomiting	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
General disorders Adverse drug reaction	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
General disorders Asthenia	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
General disorders Chest pain	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
General disorders Device stimulation issue	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
General disorders Drug withdrawal syndrome	3.6% 2/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	3.3% 2/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
General disorders Fatigue	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	5.0% 3/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
General disorders Hernia	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
General disorders Implant site pain	5.5% 3/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
General disorders Swelling	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
General disorders Temperature intolerance	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
General disorders Therapeutic product ineffective	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Hepatobiliary disorders Liver injury	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Immune system disorders Drug hypersensitivity	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Infections and infestations Breast infection	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Infections and infestations Candidiasis	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Infections and infestations Folliculitis	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Infections and infestations Gastroenteritis	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Infections and infestations Herpes zoster	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Infections and infestations Implant site infection	3.6% 2/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Infections and infestations Lower respiratory tract infection	3.6% 2/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Infections and infestations Nasopharyngitis	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Infections and infestations Sinusitis	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Infections and infestations Urinary tract infection	0.00% 0/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	1.7% 1/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Injury, poisoning and procedural complications Contusion	3.6% 2/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.
Injury, poisoning and procedural complications Epicondylitis	1.8% 1/55 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.	0.00% 0/60 • Adverse events were collected from randomization through the study end (up to 36 months follow-up). All adverse event were collected, regardless of relationship to device or therapy. Whether an event met the criteria of serious was determined by the study site. The Safety Patient Set was pre-defined as all subjects of the Intent to Treat patient set (n=116) who started any of the study procedures, independent of the treatment they had been randomized to. There were 115 patients included in the Safety Patient Set: 55 patients in the SQS+OMM and 60 patients in the OMM alone arm.