Trial Outcomes & Findings for Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock (NCT NCT01046669)

NCT ID: NCT01046669

Last Updated: 2019-02-26

Results Overview

Compare mortality at 28 days in subjects treated with standard medical care plus PMX cartridge, versus subjects who received standard medical care alone

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 450 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2019-02-26

Participant Flow

450 subjects randomized out of 921 clinically eligible subjects in 55 ICUs. First patient screened in Jun 2010, last patient screened in Jun 2016.

The following screened subjects were not randomized: * Subject's EAA <0.06 EA units * Subject met an exclusion criteria prior to randomization * Informed consent for the treatment phase of the study was not signed or consent withdrawn prior to randomization. Subjects who were randomized but not treated (RNT) were not part of safety analysis.

Participant milestones

Measure	Sham Standard medical care for septic shock	Treatment Two (2) PMX cartridges administered approximately 24 hours apart, plus standard medical care for septic shock.
Overall Study STARTED	226	224
Overall Study COMPLETED	226	223
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock

Baseline characteristics by cohort

Measure	Sham n=226 Participants Standard medical care for septic shock	Treatment n=224 Participants Two (2) PMX cartridges administered approximately 24 hours apart, plus standard medical care for septic shock	Total n=450 Participants Total of all reporting groups
Age, Continuous	58.8 years STANDARD_DEVIATION 14.7 • n=5 Participants	60.9 years STANDARD_DEVIATION 15.1 • n=7 Participants	59.8 years STANDARD_DEVIATION 14.9 • n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants	84 Participants n=7 Participants	177 Participants n=5 Participants
Sex: Female, Male Male	133 Participants n=5 Participants	140 Participants n=7 Participants	273 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	187 participants n=5 Participants	183 participants n=7 Participants	370 participants n=5 Participants
Race/Ethnicity, Customized Black	13 participants n=5 Participants	22 participants n=7 Participants	35 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	12 participants n=5 Participants	10 participants n=7 Participants	22 participants n=5 Participants
Race/Ethnicity, Customized Asian	9 participants n=5 Participants	3 participants n=7 Participants	12 participants n=5 Participants
Race/Ethnicity, Customized Other	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants
Region of Enrollment Canada	57 participants n=5 Participants	53 participants n=7 Participants	110 participants n=5 Participants
Region of Enrollment United States	169 participants n=5 Participants	171 participants n=7 Participants	340 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: All subjects randomized

Compare mortality at 28 days in subjects treated with standard medical care plus PMX cartridge, versus subjects who received standard medical care alone

Outcome measures

Measure	Sham n=226 Participants Standard medical care for septic shock	Treatment n=224 Participants Two (2) PMX cartridges administered approximately 24 hours apart plus standard medical care for septic shock
Mortality	78 Participants	84 Participants

Adverse Events

Sham

Serious events: 126 serious events

Other events: 60 other events

Deaths: 78 deaths

Treatment

Serious events: 140 serious events

Other events: 56 other events

Deaths: 84 deaths

Serious adverse events

Measure	Sham n=220 participants at risk Standard medical care for septic shock	Treatment n=212 participants at risk Two (2) PMX cartridges administered approximately 24 hours apart, plus standard medical care for septic shock.
Hepatobiliary disorders Cholecystitis acute	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Blood and lymphatic system disorders Anaemia	0.91% 2/220 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Blood and lymphatic system disorders Coagulopathy	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.91% 2/220 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Blood and lymphatic system disorders Heparin-induced thrombocytopenia	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Blood and lymphatic system disorders Leukocytosis	0.91% 2/220 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Blood and lymphatic system disorders Thrombocytopenia	1.8% 4/220 • Number of events 4 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	2.8% 6/212 • Number of events 6 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Cardiac disorders Acute myocardial infarction	0.91% 2/220 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Cardiac disorders Atrial fibrillation	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	1.4% 3/212 • Number of events 3 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Cardiac disorders Bradycardia	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 3 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Cardiac disorders Cardiac arrest	5.5% 12/220 • Number of events 14 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	2.8% 6/212 • Number of events 6 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Cardiac disorders Cardiac failure	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Cardiac disorders Cardiac failure congestive	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Cardiac disorders Cardio-respiratory arrest	3.6% 8/220 • Number of events 8 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Cardiac disorders Cardiogenic shock	0.45% 1/220 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Cardiac disorders Cor pulmonale chronic	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Cardiac disorders Myocardial infarction	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Cardiac disorders Pericardial effusion	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Cardiac disorders Pulseless electrical activity	1.4% 3/220 • Number of events 3 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Cardiac disorders Sinus bradycardia	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Cardiac disorders Supraventricular tachycardia	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Cardiac disorders Torsade de pointes	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Endocrine disorders Adrenal harmorrhage	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Eye disorders Retinal detachment	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Gastrointestinal disorders Abdominal compartment syndrome	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Gastrointestinal disorders Abdominal pain	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 3 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Gastrointestinal disorders Enterocutaneous fistula	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Gastrointestinal disorders Gastrointestinal disorder	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	2.4% 5/212 • Number of events 5 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Gastrointestinal disorders Haematochezia	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Gastrointestinal disorders Intestinal perforation	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Gastrointestinal disorders Obstructive gastric	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Gastrointestinal disorders Oesophagal perforation	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Gastrointestinal disorders Oesophagal varices haemorrhage	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Gastrointestinal disorders Pancreatitis	0.91% 2/220 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Gastrointestinal disorders Pancreatitis necrotising	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Gastrointestinal disorders Small intestinal obstruction	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Gastrointestinal disorders Vomiting	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
General disorders Cardiac Death	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
General disorders Chest pain	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
General disorders Death	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	2.8% 6/212 • Number of events 6 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
General disorders Device leakage	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
General disorders Device malfunction	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
General disorders Disease progression	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
General disorders Multi-organ failure	5.5% 12/220 • Number of events 12 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	6.6% 14/212 • Number of events 14 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
General disorders Terminal state	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
General disorders Thrombosis in device	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Hepatobiliary disorders Acute hepatic failure	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Hepatobiliary disorders Cholangitis	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
General disorders Chronic hepatic failure	0.91% 2/220 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Hepatobiliary disorders Cirrhosis alcoholic	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Hepatobiliary disorders Hepatic failure	0.91% 2/220 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	1.9% 4/212 • Number of events 4 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Hepatobiliary disorders Hepatic infarction	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Hepatobiliary disorders Hepatorenal syndrome	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Hepatobiliary disorders Liver injury	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Hepatobiliary disorders Portal vein thrombosis	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Abdominal sepsis	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Abscess	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Abscess neck	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Appendicitis	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Bacterial sepsis	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Hepatobiliary disorders Biliary sepsis	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Cellulitis	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Clostridium difficile colitis	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Diverticulitis	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Empyema	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Enterococcal infection	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Gangrene	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Necrotising fasciitis	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Orchitis	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Pneumonia	1.4% 3/220 • Number of events 3 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Postoperative wound infection	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Pulmonary sepsis	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Sepsis	9.1% 20/220 • Number of events 23 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	10.8% 23/212 • Number of events 26 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Septic shock	7.3% 16/220 • Number of events 17 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	6.1% 13/212 • Number of events 13 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Splenic abscess	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Staphylococcal sepsis	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Uninary tract infection	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Wound sepsis	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Injury, poisoning and procedural complications Anaphylactic transfusion reaction	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Injury, poisoning and procedural complications Brain herniation	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Injury, poisoning and procedural complications Diaphragmatic injury	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Injury, poisoning and procedural complications Gastrointestinal anastomotic leak	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Injury, poisoning and procedural complications Injury	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Injury, poisoning and procedural complications Splenic injury	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Injury, poisoning and procedural complications Toxicity to various agents	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Injury, poisoning and procedural complications Wound evisceration	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Investigations Blood lactic acid increased	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Metabolism and nutrition disorders Dehydration	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 3 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Metabolism and nutrition disorders Electrolyte imbalance	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Metabolism and nutrition disorders Failure to thrive	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Metabolism and nutrition disorders Fluid overload	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Metabolism and nutrition disorders Metabolic acidosis	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Musculoskeletal and connective tissue disorders Chondrocalcinosis pyrophosphate	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Musculoskeletal and connective tissue disorders Crystal arthropathy	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Musculoskeletal and connective tissue disorders Scleroderma	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Musculoskeletal and connective tissue disorders Soft tissue necrosis	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal carcinoma	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chloroma	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Nervous system disorders Brain injury	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Nervous system disorders Brain oedema	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Nervous system disorders Brain stem stroke	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Nervous system disorders Cerebral infarction	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 3 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Nervous system disorders Cerebrovascular accident	0.91% 2/220 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Nervous system disorders Depressed level of consciousness	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Nervous system disorders Embolic stroke	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Nervous system disorders Encephalopathy	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Nervous system disorders Haemorrhagic stroke	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Nervous system disorders Hepatic encephalopathy	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Nervous system disorders Hydrocephalus	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Nervous system disorders Ischaemic stroke	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Nervous system disorders Presyncope	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Nervous system disorders Subarachnoid haemorrhage	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Psychiatric disorders Delirium	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Psychiatric disorders Depression	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Psychiatric disorders Eating disorder	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Psychiatric disorders Mental status change	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Renal and urinary disorders Faecaluria	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Renal and urinary disorders Nephrolithiasis	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Renal and urinary disorders Renal failure	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Renal and urinary disorders Renal failure acute	2.7% 6/220 • Number of events 6 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	1.4% 3/212 • Number of events 3 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Renal and urinary disorders Renal failure chronic	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 3 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.91% 2/220 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Reproductive system and breast disorders Aspiration	1.4% 3/220 • Number of events 4 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.45% 1/220 • Number of events 3 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Reproductive system and breast disorders Epitaxis	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 3 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	1.9% 4/212 • Number of events 4 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.91% 2/220 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.5% 10/220 • Number of events 11 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	3.8% 8/212 • Number of events 10 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Skin and subcutaneous tissue disorders Purpura fulminans	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Skin and subcutaneous tissue disorders Steven-Johnson syndrome	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Vascular disorders Arteriosclerosis	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 4 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Vascular disorders Bleeding varicose vein	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Vascular disorders Deep vein thrombosis	0.91% 2/220 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Vascular disorders Embolism	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Vascular disorders Embolism venous	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Vascular disorders Haematoma	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Vascular disorders Haemorrhage	0.45% 1/220 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Vascular disorders Hypotension	0.91% 2/220 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.94% 2/212 • Number of events 2 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Vascular disorders Infarction	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Vascular disorders Ischaemia	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Vascular disorders Peripheral ischaemia	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Vascular disorders Shock haemorrhagic	0.00% 0/220 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.47% 1/212 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Vascular disorders Vascular insufficiency	0.45% 1/220 • Number of events 1 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	0.00% 0/212 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.

Other adverse events

Measure	Sham n=220 participants at risk Standard medical care for septic shock	Treatment n=212 participants at risk Two (2) PMX cartridges administered approximately 24 hours apart, plus standard medical care for septic shock.
Cardiac disorders Cardiac arrest	5.5% 12/220 • Number of events 14 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	2.8% 6/212 • Number of events 6 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
General disorders Multi-organ failure	5.5% 12/220 • Number of events 12 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	6.6% 14/212 • Number of events 14 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Sepsis	9.1% 20/220 • Number of events 23 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	10.8% 23/212 • Number of events 26 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.
Infections and infestations Septic shock	7.3% 16/220 • Number of events 17 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.	6.1% 13/212 • Number of events 13 • Adverse events collected from Day 0 to Day 28. Serious adverse events (SAE, SADE, USADE) collected from Day 0 to 12 months post treatment. Subjects who were randomized but not treated (RNT) were not part of the safety analysis. 12 out of 224 in the Treatment arm withdrew/were withdrawn prior to study treatment administration. Therefore, number of subjects at risk in this group is 212. 6 out of 226 in the Sham arm withdrew/were withdrawn prior to sham procedure. Therefore, number of subjects at risk in this group is 220.

Additional Information

Debra Foster, VP Clinical Development

Spectral Diagnostics Inc.

Phone: 4166263233

Email: dfoster@spectraldx.com

Results disclosure agreements

• Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor will be given a copy of the disclosure for review at least 60 days prior to the date of submission for publication or public disclosure. Sponsor may request to delete confidential information, other than study data. PI agrees to discuss with sponsor any of sponsor's suggestions with respect to the presentation of study data and the timing of the disclosure.
• Publication restrictions are in place

Restriction type: OTHER