Trial Outcomes & Findings for Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D) (NCT NCT02879383)

NCT ID: NCT02879383

Last Updated: 2024-02-14

Results Overview

The primary efficacy endpoint is the change from baseline at 24 weeks in HbA1c, DMR vs Sham

Recruitment status

COMPLETED

Study phase

Target enrollment

109 participants

Primary outcome timeframe

Baseline and 24 Weeks post-procedure

Results posted on

2024-02-14

Participant Flow

All subjects participated in a 4-week oral antidiabetic drug (OAD) run-in period before the index procedure to confirm lack of blood glucose control in conjunction with medication compliance and nutritional counseling. All subjects were managed according to current diabetes standard of care.

Participant milestones

Participant milestones
Measure	DMR Procedure (Europe) Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks. DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System	Sham Procedure (Europe) Subjects are unblinded at 24 Weeks. Sham subjects given option to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Not all patients crossed over and received DMR treatment at 24 Weeks. Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.	DMR Procedure (Brazil) Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks. DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System	Sham Procedure (Brazil) Subjects are unblinded at 24 Weeks. Sham subjects given option to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Not all patients crossed over and received DMR treatment at 24 Weeks. Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
First 24 Weeks STARTED	39	37	17	16
First 24 Weeks COMPLETED	39	36	17	16
First 24 Weeks NOT COMPLETED	0	1	0	0
Second 24 Weeks (Crossover for Sham) STARTED	33	0	4	0
Second 24 Weeks (Crossover for Sham) COMPLETED	33	0	4	0
Second 24 Weeks (Crossover for Sham) NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	DMR Procedure (Europe) Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks. DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System	Sham Procedure (Europe) Subjects are unblinded at 24 Weeks. Sham subjects given option to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Not all patients crossed over and received DMR treatment at 24 Weeks. Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.	DMR Procedure (Brazil) Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks. DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System	Sham Procedure (Brazil) Subjects are unblinded at 24 Weeks. Sham subjects given option to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Not all patients crossed over and received DMR treatment at 24 Weeks. Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
First 24 Weeks Physician Decision	0	1	0	0

Baseline Characteristics

Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DMR Procedure (Europe) n=39 Participants Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks. DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System	Sham Procedure (Europe) n=36 Participants Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.	DMR Procedure (Brazil) n=17 Participants Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks. DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System	Sham Procedure (Brazil) n=16 Participants Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.	Total n=108 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=5 Participants	30 Participants n=7 Participants	16 Participants n=5 Participants	13 Participants n=4 Participants	86 Participants n=21 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	22 Participants n=21 Participants
Age, Continuous	59 years n=5 Participants	56.5 years n=7 Participants	56 years n=5 Participants	57.6 years n=4 Participants	58 years n=21 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	8 Participants n=4 Participants	33 Participants n=21 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	28 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	75 Participants n=21 Participants
Race/Ethnicity, Customized Race · White	25 Participants n=5 Participants	21 Participants n=7 Participants	12 Participants n=5 Participants	13 Participants n=4 Participants	71 Participants n=21 Participants
Race/Ethnicity, Customized Race · Black	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Race · undisclosed	13 Participants n=5 Participants	12 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	25 Participants n=21 Participants
Region of Enrollment Netherlands	8 participants n=5 Participants	9 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	17 participants n=21 Participants
Region of Enrollment Belgium	9 participants n=5 Participants	7 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	16 participants n=21 Participants
Region of Enrollment Brazil	0 participants n=5 Participants	0 participants n=7 Participants	17 participants n=5 Participants	16 participants n=4 Participants	33 participants n=21 Participants
Region of Enrollment United Kingdom	11 participants n=5 Participants	12 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	23 participants n=21 Participants
Region of Enrollment Italy	11 participants n=5 Participants	8 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	19 participants n=21 Participants
BMI (kg/m2)	31.4 kg/m2 n=5 Participants	30.4 kg/m2 n=7 Participants	32.3 kg/m2 n=5 Participants	31.6 kg/m2 n=4 Participants	31.4 kg/m2 n=21 Participants
Fasting Glucose	191 mg/dL n=5 Participants	185 mg/dL n=7 Participants	190 mg/dL n=5 Participants	182 mg/dL n=4 Participants	187 mg/dL n=21 Participants
HbA1c (%)	8.1 % of glycosylated hemoglobin n=5 Participants	8.2 % of glycosylated hemoglobin n=7 Participants	8.6 % of glycosylated hemoglobin n=5 Participants	8.15 % of glycosylated hemoglobin n=4 Participants	8.26 % of glycosylated hemoglobin n=21 Participants
MRI-PDFF (%) among subjects with baseline MRI-PDFF >5%	16.46 % of liver fat n=5 Participants	16.11 % of liver fat n=7 Participants	16.45 % of liver fat n=5 Participants	16.98 % of liver fat n=4 Participants	16.5 % of liver fat n=21 Participants

PRIMARY outcome

Timeframe: Baseline and 24 Weeks post-procedure

Population: mITT population

The primary efficacy endpoint is the change from baseline at 24 weeks in HbA1c, DMR vs Sham

Outcome measures

Outcome measures
Measure	DMR Procedure (Brazil) n=17 Participants Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks. DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System	Sham Procedure (Brazil) n=16 Participants Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.	DMR Procedure (Europe) n=39 Participants Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks. DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System	Sham Procedure (Europe) n=36 Participants Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
Change From Baseline at 24 Weeks in Hemoglobin A1c (HbA1c), DMR vs Sham.	-1.85 percentage change from baseline Interval -2.4 to -1.1	-1.60 percentage change from baseline Interval -2.0 to -1.1	-0.60 percentage change from baseline Interval -1.4 to 0.2	-0.30 percentage change from baseline Interval -0.8 to 0.2

PRIMARY outcome

Timeframe: Baseline and 12 Weeks post-procedure

Population: mITT population; not all patients from participant flow were able to undergo a MRI-PDFF. All patients who had a MRI-PDFF performed are analyzed and represented below.

The absolute change from baseline at 12 weeks in MR-PDFF in patients with baseline MR-PDFF \> 5% , DMR vs Sham

Outcome measures

Outcome measures
Measure	DMR Procedure (Brazil) n=15 Participants Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks. DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System	Sham Procedure (Brazil) n=15 Participants Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.	DMR Procedure (Europe) n=33 Participants Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks. DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System	Sham Procedure (Europe) n=28 Participants Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
Change From Baseline at 12 Weeks in MR-PDFF, DMR vs Sham	-5.4 percentage change from baseline Interval -12.0 to -2.84	-6.07 percentage change from baseline Interval -10.95 to -3.12	-5.4 percentage change from baseline Interval -8.35 to -2.25	-2.24 percentage change from baseline Interval -4.61 to -0.32

Adverse Events

Sham Procedure (Europe)

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

DMR Procedure (Brazil)

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Sham Procedure (Brazil)

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Sham Crossover (Europe)

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Sham Crossover (Brazil)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

DMR Procedure (Europe)

Serious events: 5 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sham Procedure (Europe) n=37 participants at risk Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.	DMR Procedure (Brazil) n=17 participants at risk Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks. DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System	Sham Procedure (Brazil) n=16 participants at risk Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.	Sham Crossover (Europe) n=33 participants at risk Subjects that were in sham arm (Europe) until 24 weeks and then crossover to receive DMR treatment at 24 weeks and followed up for additional 24 weeks. AEs captured from time of DMR procedure through follow up to end of study.	Sham Crossover (Brazil) n=4 participants at risk Subjects that were in sham arm (Brazil) until 24 weeks and then crossover to receive DMR treatment at 24 weeks and followed up for additional 24 weeks. AEs captured from time of DMR procedure through follow up to end of study.	DMR Procedure (Europe) n=39 participants at risk Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks. DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
Gastrointestinal disorders Jejunal perforation	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Cardiac disorders Acute myocardial infarction	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	2.6% 1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Musculoskeletal and connective tissue disorders back pain	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	2.6% 1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Ear and labyrinth disorders Ear Disorder	2.7% 1/37 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	2.6% 1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Injury, poisoning and procedural complications Arterial injury	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	2.6% 1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	2.6% 1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.

Other adverse events

Other adverse events
Measure	Sham Procedure (Europe) n=37 participants at risk Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.	DMR Procedure (Brazil) n=17 participants at risk Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks. DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System	Sham Procedure (Brazil) n=16 participants at risk Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.	Sham Crossover (Europe) n=33 participants at risk Subjects that were in sham arm (Europe) until 24 weeks and then crossover to receive DMR treatment at 24 weeks and followed up for additional 24 weeks. AEs captured from time of DMR procedure through follow up to end of study.	Sham Crossover (Brazil) n=4 participants at risk Subjects that were in sham arm (Brazil) until 24 weeks and then crossover to receive DMR treatment at 24 weeks and followed up for additional 24 weeks. AEs captured from time of DMR procedure through follow up to end of study.	DMR Procedure (Europe) n=39 participants at risk Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks. DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
Gastrointestinal disorders Abdominal pain	10.8% 4/37 • Number of events 4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	29.4% 5/17 • Number of events 5 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	9.1% 3/33 • Number of events 5 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	17.9% 7/39 • Number of events 7 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Blood and lymphatic system disorders Iron Deficiency anaemia	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Gastrointestinal disorders Abdominal pain upper	5.4% 2/37 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	17.6% 3/17 • Number of events 4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	12.5% 2/16 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	24.2% 8/33 • Number of events 9 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	7.7% 3/39 • Number of events 4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Gastrointestinal disorders constipation	2.7% 1/37 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	12.5% 2/16 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	3.0% 1/33 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	2.6% 1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Gastrointestinal disorders Diarrhoea	16.2% 6/37 • Number of events 8 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	11.8% 2/17 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.2% 1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	15.2% 5/33 • Number of events 7 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	25.0% 1/4 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	2.6% 1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Gastrointestinal disorders Dyspepsia	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.2% 1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	3.0% 1/33 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Gastrointestinal disorders duodenitis	10.8% 4/37 • Number of events 4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	3.0% 1/33 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	10.3% 4/39 • Number of events 4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Gastrointestinal disorders Oesophagitis	5.4% 2/37 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	11.8% 2/17 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	7.7% 3/39 • Number of events 3 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Gastrointestinal disorders vomiting	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.1% 2/33 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.1% 2/39 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Gastrointestinal disorders Gastritis Erosive	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Gastrointestinal disorders Hematochezia	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Gastrointestinal disorders haemorrhoids	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Gastrointestinal disorders Nausea	2.7% 1/37 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	17.6% 3/17 • Number of events 3 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	9.1% 3/33 • Number of events 3 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	2.6% 1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Gastrointestinal disorders Toothache	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
General disorders asthenia	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	11.8% 2/17 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.1% 2/33 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
General disorders polyp	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
General disorders fatigue	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	3.0% 1/33 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.1% 2/39 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
General disorders Oedema peripheral	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.1% 2/39 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Immune system disorders food allergy	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Infections and infestations Cystitis	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	7.7% 3/39 • Number of events 3 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Infections and infestations Ear infection	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.1% 2/39 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Infections and infestations Influenza	5.4% 2/37 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.2% 1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.1% 2/39 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Infections and infestations Gastroenteritis	2.7% 1/37 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	3.0% 1/33 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Infections and infestations Infection	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Infections and infestations Nasopharyngitis	13.5% 5/37 • Number of events 6 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	15.2% 5/33 • Number of events 5 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	12.8% 5/39 • Number of events 6 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Infections and infestations Pharyngitis	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	3.0% 1/33 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	2.6% 1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Infections and infestations pneumonia	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Infections and infestations Respiratory tract infection	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Infections and infestations Subcutaneous abscess	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Infections and infestations Upper respiratory tract infection	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	12.5% 2/16 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	25.0% 1/4 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Infections and infestations Urinary tract infection	2.7% 1/37 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.2% 1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	10.3% 4/39 • Number of events 4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Metabolism and nutrition disorders Hypoglycaemia	18.9% 7/37 • Number of events 13 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	64.7% 11/17 • Number of events 106 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	75.0% 12/16 • Number of events 107 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	12.1% 4/33 • Number of events 10 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	50.0% 2/4 • Number of events 16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	17.9% 7/39 • Number of events 16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Metabolism and nutrition disorders Hyperglycaemia	10.8% 4/37 • Number of events 11 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	18.2% 6/33 • Number of events 11 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	12.8% 5/39 • Number of events 36 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Renal and urinary disorders Urinary Incontinence	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.2% 1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Gastrointestinal disorders abdominal Discomfort	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.1% 2/33 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Infections and infestations conjunctivitis	2.7% 1/37 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.2% 1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	2.6% 1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Metabolism and nutrition disorders vitamin D deficiency	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	18.8% 3/16 • Number of events 3 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.2% 1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.2% 1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.1% 2/39 • Number of events 3 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Musculoskeletal and connective tissue disorders back pain	8.1% 3/37 • Number of events 3 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.1% 2/33 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	12.8% 5/39 • Number of events 5 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.2% 1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Nervous system disorders Diabetic neuropathy	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.2% 1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Nervous system disorders Headache	2.7% 1/37 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	17.6% 3/17 • Number of events 3 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	12.5% 2/16 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	7.7% 3/39 • Number of events 4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Psychiatric disorders Generalised anxiety disorder	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Surgical and medical procedures Hydrocele operation	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Surgical and medical procedures Inguinal hernia repair	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.4% 2/37 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.2% 1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	3.0% 1/33 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.1% 2/39 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Vascular disorders Orthostatic hypotension	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.9% 1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	3.0% 1/33 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Skin and subcutaneous tissue disorders Pruritus	2.7% 1/37 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	5.1% 2/39 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Respiratory, thoracic and mediastinal disorders asthma	5.4% 2/37 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Blood and lymphatic system disorders anaemia	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.2% 1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Nervous system disorders Dizziness	2.7% 1/37 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.2% 1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	2.6% 1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Renal and urinary disorders Nephrolithiasis	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.2% 1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Renal and urinary disorders Renal Cyst	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.2% 1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Infections and infestations Oral Herpes	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	25.0% 1/4 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Injury, poisoning and procedural complications fall	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	25.0% 1/4 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Injury, poisoning and procedural complications limb injury	2.7% 1/37 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	25.0% 1/4 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Nervous system disorders facial paralysis	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	25.0% 1/4 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Respiratory, thoracic and mediastinal disorders cough	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	12.1% 4/33 • Number of events 4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
Injury, poisoning and procedural complications ligament sprain	0.00% 0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	6.1% 2/33 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.	0.00% 0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.

Additional Information

Sarah Hackett, Director of Clinical Operations

Fractyl Laboratories, Inc.

Phone: (781) 902-8840

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60