Trial Outcomes & Findings for ILLUMENATE Pivotal Post-Approval Study (PAS) (NCT NCT03421561)

NCT ID: NCT03421561

Last Updated: 2024-02-02

Results Overview

Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 300 participants
• Primary outcome timeframe: 24 months post-procedure
• Results posted on: 2024-02-02

Participant Flow

Participant milestones

Measure	DCB Subjects The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Overall Study STARTED	200	100
Overall Study COMPLETED	135	70
Overall Study NOT COMPLETED	65	30

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Not all participants reported this demographic information.

Baseline characteristics by cohort

Measure	PTA Subjects n=100 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).	Total n=300 Participants Total of all reporting groups	DCB Subjects n=200 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.
Age, Continuous	69.8 years STANDARD_DEVIATION 9.8 • n=100 Participants	68.8 years STANDARD_DEVIATION 10.2 • n=300 Participants	68.3 years STANDARD_DEVIATION 10.3 • n=200 Participants
Sex: Female, Male Female	36 Participants n=100 Participants	124 Participants n=300 Participants	88 Participants n=200 Participants
Sex: Female, Male Male	64 Participants n=100 Participants	176 Participants n=300 Participants	112 Participants n=200 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=100 Participants • Not all participants reported this demographic information.	38 Participants n=300 Participants • Not all participants reported this demographic information.	27 Participants n=200 Participants • Not all participants reported this demographic information.
Ethnicity (NIH/OMB) Not Hispanic or Latino	77 Participants n=100 Participants • Not all participants reported this demographic information.	229 Participants n=300 Participants • Not all participants reported this demographic information.	152 Participants n=200 Participants • Not all participants reported this demographic information.
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=100 Participants • Not all participants reported this demographic information.	33 Participants n=300 Participants • Not all participants reported this demographic information.	21 Participants n=200 Participants • Not all participants reported this demographic information.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=100 Participants • Not all participants reported this demographic.	2 Participants n=300 Participants • Not all participants reported this demographic.	2 Participants n=200 Participants • Not all participants reported this demographic.
Race (NIH/OMB) Asian	1 Participants n=100 Participants • Not all participants reported this demographic.	3 Participants n=300 Participants • Not all participants reported this demographic.	2 Participants n=200 Participants • Not all participants reported this demographic.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	NA Participants n=100 Participants • Not all participants reported this demographic.	NA Participants n=300 Participants • Not all participants reported this demographic.	NA Participants n=200 Participants • Not all participants reported this demographic.
Race (NIH/OMB) Black or African American	19 Participants n=100 Participants • Not all participants reported this demographic.	54 Participants n=300 Participants • Not all participants reported this demographic.	35 Participants n=200 Participants • Not all participants reported this demographic.
Race (NIH/OMB) White	68 Participants n=100 Participants • Not all participants reported this demographic.	210 Participants n=300 Participants • Not all participants reported this demographic.	142 Participants n=200 Participants • Not all participants reported this demographic.
Race (NIH/OMB) More than one race	NA Participants n=100 Participants • Not all participants reported this demographic.	NA Participants n=300 Participants • Not all participants reported this demographic.	NA Participants n=200 Participants • Not all participants reported this demographic.
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=100 Participants • Not all participants reported this demographic.	31 Participants n=300 Participants • Not all participants reported this demographic.	19 Participants n=200 Participants • Not all participants reported this demographic.
Region of Enrollment Austria	10 participants n=100 Participants	27 participants n=300 Participants	17 participants n=200 Participants
Region of Enrollment United States	90 participants n=100 Participants	273 participants n=300 Participants	183 participants n=200 Participants
Body Mass Index	28.8 kg/m^2 STANDARD_DEVIATION 5.6 • n=100 Participants	29.0 kg/m^2 STANDARD_DEVIATION 6.0 • n=300 Participants	29.0 kg/m^2 STANDARD_DEVIATION 6.1 • n=200 Participants
Ankle-Brachial Index Ankle-Brachial Index Measurement	0.76 ratio STANDARD_DEVIATION 0.20 • n=100 Participants • Data was analyzed by arm, not by total. ABI analysis returns measurement values of mmHg. Non-compressible indicates no measurement could be taken, therefore there is no measurement to analyze and report.	0.75 ratio STANDARD_DEVIATION 0.21 • n=293 Participants • Data was analyzed by arm, not by total. ABI analysis returns measurement values of mmHg. Non-compressible indicates no measurement could be taken, therefore there is no measurement to analyze and report.	0.75 ratio STANDARD_DEVIATION 0.21 • n=193 Participants • Data was analyzed by arm, not by total. ABI analysis returns measurement values of mmHg. Non-compressible indicates no measurement could be taken, therefore there is no measurement to analyze and report.
Ankle-Brachial Index Non-Compressible	—	NA ratio STANDARD_DEVIATION NA • n=6 Participants • Data was analyzed by arm, not by total. ABI analysis returns measurement values of mmHg. Non-compressible indicates no measurement could be taken, therefore there is no measurement to analyze and report.	NA ratio STANDARD_DEVIATION NA • n=6 Participants • Data was analyzed by arm, not by total. ABI analysis returns measurement values of mmHg. Non-compressible indicates no measurement could be taken, therefore there is no measurement to analyze and report.
Rutherford-Becker Clinical Category RCC 2	35 Participants n=100 Participants	98 Participants n=300 Participants	63 Participants n=200 Participants
Rutherford-Becker Clinical Category RCC 3	60 Participants n=100 Participants	189 Participants n=300 Participants	129 Participants n=200 Participants
Rutherford-Becker Clinical Category RCC 4	5 Participants n=100 Participants	13 Participants n=300 Participants	8 Participants n=200 Participants
Peripheral Vascular Disease (PVD)	100 Participants n=100 Participants	300 Participants n=300 Participants	200 Participants n=200 Participants
Hypertension	94 Participants n=100 Participants	281 Participants n=300 Participants	187 Participants n=200 Participants
Hyperlipidemia	90 Participants n=100 Participants	266 Participants n=300 Participants	176 Participants n=200 Participants
Myocardial Infarction (MI)	22 Participants n=100 Participants	64 Participants n=300 Participants	42 Participants n=200 Participants
Angina Pectoris	20 Participants n=100 Participants	50 Participants n=300 Participants	30 Participants n=200 Participants
Congestive Heart Failure (CHF)	8 Participants n=100 Participants	32 Participants n=300 Participants	24 Participants n=200 Participants
Previous Percutaneous or Surgical Coronary Revascularization	48 Participants n=100 Participants	138 Participants n=300 Participants	90 Participants n=200 Participants
Renal Insufficiency	17 Participants n=100 Participants	53 Participants n=300 Participants	36 Participants n=200 Participants
Liver Disease	4 Participants n=100 Participants	11 Participants n=300 Participants	7 Participants n=200 Participants
Cerebrovascular Disease	20 Participants n=100 Participants	67 Participants n=300 Participants	47 Participants n=200 Participants
Chronic Obstructive Pulmonary Occlusion (COPD)	21 Participants n=100 Participants	53 Participants n=300 Participants	32 Participants n=200 Participants
Deep Vein Thrombosis (DVT)	4 Participants n=100 Participants	10 Participants n=300 Participants	6 Participants n=200 Participants
Diabetes (Total)	52 Participants n=100 Participants	151 Participants n=300 Participants	99 Participants n=200 Participants
Diabetes - Type I	3 Participants n=100 Participants	11 Participants n=300 Participants	8 Participants n=200 Participants
Diabetes - Type II	49 Participants n=100 Participants	140 Participants n=300 Participants	91 Participants n=200 Participants
Smoker Never Smoked	24 Participants n=100 Participants	56 Participants n=300 Participants	32 Participants n=200 Participants
Smoker Previous or Current Smoker	76 Participants n=100 Participants	244 Participants n=300 Participants	168 Participants n=200 Participants
Previous Intervention of the Lower Limb	41 Participants n=100 Participants	128 Participants n=300 Participants	87 Participants n=200 Participants
Previous Intervention of the Study Limb	23 Participants n=100 Participants	71 Participants n=300 Participants	48 Participants n=200 Participants

PRIMARY outcome

Timeframe: 24 months post-procedure

Population: Patency was defined as absence of target lesion restenosis (as assessed by the duplex ultrasound core laboratory based on PSVR ≤ 2.5) and CD-TLR through 24 months (defined as 730 ± 45 days, i.e., up to 775 days) or angiographic core laboratory assessment of restenosis. Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.

Outcome measures

Measure	DCB Subjects n=146 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=87 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Number of Participants With Target Vessel Patency at 24 Months Post-procedure	88 Participants	45 Participants

PRIMARY outcome

Timeframe: 24 months post-procedure

Population: Subject was considered a failure if they experienced device or procedure-related death within 30 days, or if they experienced target limb major amputation or CD-TLR within 24 months (defined as 730 ± 45 days, i.e., up to 775 days). Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

The primary safety outcome is defined as freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 24 months post-procedure (defined as 730 ± 45 days, i.e., up to 775 days).

Outcome measures

Measure	DCB Subjects n=171 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=92 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Number of Participants With Freedom From Device and Procedure Related Death Through 30 Days Post-procedure and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization Through 24 Months Post-procedure	142 Participants	73 Participants

SECONDARY outcome

Timeframe: 24 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Major adverse event (MAE) rate at 24 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).

Outcome measures

Measure	DCB Subjects n=183 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=94 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Major Adverse Event (MAE) Rate at 24 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)	34 Participants	22 Participants

SECONDARY outcome

Timeframe: 36 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Major adverse event (MAE) rate at 36 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).

Outcome measures

Measure	DCB Subjects n=176 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=91 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Major Adverse Event (MAE) Rate at 36 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)	46 Participants	27 Participants

SECONDARY outcome

Timeframe: 48 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Major adverse event (MAE) rate at 48 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).

Outcome measures

Measure	DCB Subjects n=166 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=88 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Major Adverse Event (MAE) Rate at 48 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)	55 Participants	33 Participants

SECONDARY outcome

Timeframe: 60 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Major adverse event (MAE) rate at 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).

Outcome measures

Measure	DCB Subjects n=156 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=83 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Major Adverse Event (MAE) Rate at 60 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)	64 Participants	37 Participants

SECONDARY outcome

Timeframe: 24 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis >50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.

Outcome measures

Measure	DCB Subjects n=179 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=92 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Clinically-driven Target Lesion Revascularization	29 Participants	19 Participants

SECONDARY outcome

Timeframe: 36 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis >50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.

Outcome measures

Measure	DCB Subjects n=170 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=88 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Clinically-driven Target Lesion Revascularization	38 Participants	24 Participants

SECONDARY outcome

Timeframe: 48 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis >50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.

Outcome measures

Measure	DCB Subjects n=158 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=83 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Clinically-driven Target Lesion Revascularization	44 Participants	28 Participants

SECONDARY outcome

Timeframe: 60 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis >50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.

Outcome measures

Measure	DCB Subjects n=143 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=75 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Clinically-driven Target Lesion Revascularization	51 Participants	29 Participants

SECONDARY outcome

Timeframe: 24 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee

Outcome measures

Measure	DCB Subjects n=180 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=92 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Target Lesion Revascularization	32 Participants	20 Participants

SECONDARY outcome

Timeframe: 36 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee

Outcome measures

Measure	DCB Subjects n=171 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=88 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Target Lesion Revascularization	42 Participants	25 Participants

SECONDARY outcome

Timeframe: 48 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee

Outcome measures

Measure	DCB Subjects n=159 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=83 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Target Lesion Revascularization	48 Participants	29 Participants

SECONDARY outcome

Timeframe: 60 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee

Outcome measures

Measure	DCB Subjects n=144 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=76 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Target Lesion Revascularization	55 Participants	30 Participants

SECONDARY outcome

Timeframe: 24 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Lesion revascularization occuring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis >50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.

Outcome measures

Measure	DCB Subjects n=178 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=91 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Clinically-driven Target Vessel Revascularization	1 Participants	1 Participants

SECONDARY outcome

Timeframe: 36 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis >50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.

Outcome measures

Measure	DCB Subjects n=169 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=83 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Clinically-driven Target Vessel Revascularization	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 48 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis >50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.

Outcome measures

Measure	DCB Subjects n=155 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=78 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Clinically-driven Target Vessel Revascularization	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 60 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis >50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.

Outcome measures

Measure	DCB Subjects n=135 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=67 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Clinically-driven Target Vessel Revascularization	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 24 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Number of subjects in which a major amputation occurred in the target limb

Outcome measures

Measure	DCB Subjects n=178 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=91 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Target Limb Major Amputation	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 36 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Number of subjects in which a major amputation occurred in the target limb

Outcome measures

Measure	DCB Subjects n=169 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=83 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Target Limb Major Amputation	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Number of subjects in which a major amputation occurred in the target limb

Outcome measures

Measure	DCB Subjects n=155 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=78 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Target Limb Major Amputation	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 60 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Number of subjects in which a major amputation occurred in the target limb

Outcome measures

Measure	DCB Subjects n=137 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=67 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Target Limb Major Amputation	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Number of subject who have died during the post-procedure follow up period

Outcome measures

Measure	DCB Subjects n=190 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=97 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Mortality Rate	13 Participants	8 Participants

SECONDARY outcome

Timeframe: 36 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Number of subject who have died during the post-procedure follow up period

Outcome measures

Measure	DCB Subjects n=185 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=93 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Mortality Rate	18 Participants	10 Participants

SECONDARY outcome

Timeframe: 48 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Number of subject who have died during the post-procedure follow up period

Outcome measures

Measure	DCB Subjects n=178 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=91 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Mortality Rate	27 Participants	14 Participants

SECONDARY outcome

Timeframe: 60 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Number of subject who have died during the post-procedure follow up period

Outcome measures

Measure	DCB Subjects n=169 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=86 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Mortality Rate	34 Participants	19 Participants

SECONDARY outcome

Timeframe: 24 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Rate of occurrence of arterial thrombosis of the treated segment

Outcome measures

Measure	DCB Subjects n=178 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=91 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Occurrence of Arterial Thrombosis of the Treated Segment	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 36 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Rate of occurrence of arterial thrombosis of the treated segment

Outcome measures

Measure	DCB Subjects n=169 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=83 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Occurrence of Arterial Thrombosis of the Treated Segment	4 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Rate of occurrence of arterial thrombosis of the treated segment

Outcome measures

Measure	DCB Subjects n=155 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=78 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Occurrence of Arterial Thrombosis of the Treated Segment	4 Participants	0 Participants

SECONDARY outcome

Timeframe: 60 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Rate of occurrence of arterial thrombosis of the treated segment

Outcome measures

Measure	DCB Subjects n=135 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=67 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Rate of Occurrence of Arterial Thrombosis of the Treated Segment	4 Participants	0 Participants

SECONDARY outcome

Timeframe: 24 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR

Outcome measures

Measure	DCB Subjects n=146 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=87 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR	88 Participants	45 Participants

SECONDARY outcome

Timeframe: 36 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR

Outcome measures

Measure	DCB Subjects n=116 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=73 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR	65 Participants	35 Participants

SECONDARY outcome

Timeframe: 24 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease.

Outcome measures

Measure	DCB Subjects n=141 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=79 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Change in Ankle-brachial Index (ABI) From Pre-procedure Improved	102 Participants	56 Participants
Change in Ankle-brachial Index (ABI) From Pre-procedure No Change	0 Participants	1 Participants
Change in Ankle-brachial Index (ABI) From Pre-procedure Worsened	39 Participants	22 Participants

SECONDARY outcome

Timeframe: 36 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease.

Outcome measures

Measure	DCB Subjects n=120 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=69 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Change in Ankle-brachial Index (ABI) From Pre-procedure Improved	89 Participants	46 Participants
Change in Ankle-brachial Index (ABI) From Pre-procedure Worsened	31 Participants	23 Participants

SECONDARY outcome

Timeframe: 24 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication

Outcome measures

Measure	DCB Subjects n=153 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=82 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure Improved	114 Participants	63 Participants
Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure Worsened	39 Participants	19 Participants

SECONDARY outcome

Timeframe: 36 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication

Outcome measures

Measure	DCB Subjects n=131 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=74 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure Improved	98 Participants	50 Participants
Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure No Change	1 Participants	0 Participants
Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure Worsened	32 Participants	24 Participants

SECONDARY outcome

Timeframe: 24 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 24 month office visit.

Outcome measures

Measure	DCB Subjects n=142 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=80 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Change in Walking Distance From Pre-procedure Improved	92 Participants	57 Participants
Change in Walking Distance From Pre-procedure No Change	1 Participants	1 Participants
Change in Walking Distance From Pre-procedure Worsened	49 Participants	22 Participants

SECONDARY outcome

Timeframe: 36 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 36 month office visit.

Outcome measures

Measure	DCB Subjects n=114 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=69 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Change in Walking Distance From Pre-procedure Improved	77 Participants	47 Participants
Change in Walking Distance From Pre-procedure No Change	2 Participants	0 Participants
Change in Walking Distance From Pre-procedure Worsened	35 Participants	22 Participants

SECONDARY outcome

Timeframe: 24 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease.

Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease

Mild claudication Moderate claudication Severe claudication 4*-Ischemic rest pain 5*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable *Categories 4, 5, and 6 are also described as critical limb ischemia.

Outcome measures

Measure	DCB Subjects n=153 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=82 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Change in Rutherford-Becker Classification From Pre-procedure Improved	128 Participants	74 Participants
Change in Rutherford-Becker Classification From Pre-procedure No Change	17 Participants	5 Participants
Change in Rutherford-Becker Classification From Pre-procedure Worsened	8 Participants	3 Participants

SECONDARY outcome

Timeframe: 36 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease.

Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease

Mild claudication Moderate claudication Severe claudication 4*-Ischemic rest pain 5*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable *Categories 4, 5, and 6 are also described as critical limb ischemia.

Outcome measures

Measure	DCB Subjects n=130 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=76 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Change in Rutherford-Becker Classification From Pre-procedure Improved	108 Participants	63 Participants
Change in Rutherford-Becker Classification From Pre-procedure No Change	15 Participants	11 Participants
Change in Rutherford-Becker Classification From Pre-procedure Worsened	7 Participants	2 Participants

SECONDARY outcome

Timeframe: 24 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.

Outcome measures

Measure	DCB Subjects n=103 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=59 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Change in EQ-5D Index From Pre-procedure Improved	62 Participants	37 Participants
Change in EQ-5D Index From Pre-procedure No Change	9 Participants	7 Participants
Change in EQ-5D Index From Pre-procedure Worsened	32 Participants	15 Participants

SECONDARY outcome

Timeframe: 36 months post-procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.

Outcome measures

Measure	DCB Subjects n=95 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=56 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Change in EQ-5D Index From Pre-procedure Improved	52 Participants	35 Participants
Change in EQ-5D Index From Pre-procedure No Change	15 Participants	6 Participants
Change in EQ-5D Index From Pre-procedure Worsened	28 Participants	15 Participants

SECONDARY outcome

Timeframe: 24 months post procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion

Outcome measures

Measure	DCB Subjects n=104 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=59 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Change in EQ-5D VAS From Pre-procedure Improved	52 Participants	30 Participants
Change in EQ-5D VAS From Pre-procedure No Change	12 Participants	10 Participants
Change in EQ-5D VAS From Pre-procedure Worsened	40 Participants	19 Participants

SECONDARY outcome

Timeframe: 36 month post procedure

Population: Denominators represent the number of intent-to-treat participants from each arm for whom data are available for this outcome (200 DCB and 100 PTA were enrolled).

EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion

Outcome measures

Measure	DCB Subjects n=95 Participants The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=56 Participants The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Change in EQ-5D VAS From Pre-procedure Improved	53 Participants	26 Participants
Change in EQ-5D VAS From Pre-procedure No Change	6 Participants	9 Participants
Change in EQ-5D VAS From Pre-procedure Worsened	36 Participants	21 Participants

Adverse Events

DCB Subjects

Serious events: 177 serious events

Other events: 192 other events

Deaths: 34 deaths

PTA Subjects

Serious events: 85 serious events

Other events: 95 other events

Deaths: 19 deaths

Serious adverse events

Measure	DCB Subjects n=200 participants at risk The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=100 participants at risk The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Metabolism and nutrition disorders HYPERKALAEMIA	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Metabolism and nutrition disorders HYPOCALCAEMIA	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Blood and lymphatic system disorders Anaemia	4.0% 8/200 • Number of events 12 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	3.0% 3/100 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Blood and lymphatic system disorders Haemorrhagic Anaemia	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Blood and lymphatic system disorders Hypchromic Anaemia	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Blood and lymphatic system disorders Iron Deficiency Anaemia	0.50% 1/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Blood and lymphatic system disorders Leukocytosis	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Blood and lymphatic system disorders Nephrogenic Anaemia	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Acute Myocardial Infarction	3.5% 7/200 • Number of events 11 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	3.0% 3/100 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Angina Pectoris	5.5% 11/200 • Number of events 14 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Angina Unstable	2.5% 5/200 • Number of events 7 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Aortic Valve Stenosis	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Arrhythmia	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Atrial Fibrillation	4.0% 8/200 • Number of events 10 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	6.0% 6/100 • Number of events 13 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Atrioventricular Block	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Atrioventricular Block Complete	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Atrioventricular Block Second Degree	1.0% 2/200 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Bradycardia	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Cardiac Arrest	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Cardiac Disorder	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Cardiac Failure	3.0% 6/200 • Number of events 6 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 10 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Cardiac Failure Acute	1.0% 2/200 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Cardiac Failure Congestive	6.0% 12/200 • Number of events 20 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	5.0% 5/100 • Number of events 6 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Cardio-Respiratory Arrest	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Cardiogenic Shock	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Coronary Artery Disease	6.0% 12/200 • Number of events 14 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	4.0% 4/100 • Number of events 5 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Coronary Artery Occlusion	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Coronary Artery Stenosis	2.0% 4/200 • Number of events 4 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Ischaemic Cardiomyopathy	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Mitral Valve Incompetance	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Myocardial Infarction	1.5% 3/200 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Sick Sinus Syndrome	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Sinus Bradycardia	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Sinus Tachycardia	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Stress Cardiomyopathy	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Tachycardia	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Torsade de Pointes	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Ventricular Tachycardia	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Ear and labyrinth disorders Vertigo	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Ear and labyrinth disorders Vertigo Positional	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Endocrine disorders Hypothyroidism	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Eye disorders Blindness Unilateral	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Eye disorders Cataract	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Eye disorders Macular Fibrosis	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Eye disorders Retinal Artery Occlusion	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Abdominal Discomfort	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Abdominal Hernia	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Abdominal Pain	1.5% 3/200 • Number of events 4 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	3.0% 3/100 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Abdominal Pain Lower	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Abdominal Pain Upper	2.0% 4/200 • Number of events 4 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Barrett's Oesophagus	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Colitis	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Diarrhoea	1.5% 3/200 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Diarrhoea Haemorrhagic	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Diverticulum	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Duodenal Ulcer	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Dysphagia	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Gastric Ulcer	1.0% 2/200 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Gastritis	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Gastritis Erosive	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Gastrointestinal Angiodysplasia	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Gastrointestinal Angiodysplasia Haemorrhagic	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Gastrointestinal Haemorrhage	3.5% 7/200 • Number of events 7 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Inguinal Hernia	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Intestinal Ischaemia	2.0% 4/200 • Number of events 5 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Large Intestine Polyp	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Melaena	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Nausea	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Pancreatitis	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Pancreatitis Acute	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Rectal Haemorrhage	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Retroperitoneal Haematoma	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Retroperitoneal Haemorrhage	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Small Intestine Obstruction	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Umbilical Hernia	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders Upper Gastrointestinal Haemorrhage	0.50% 1/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders Asthenia	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders Catheter Site Hematoma	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders Catheter Site Haemorrhage	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders Chest Discomfort	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders Chest Pain	10.0% 20/200 • Number of events 30 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	8.0% 8/100 • Number of events 8 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders Death	2.0% 4/200 • Number of events 4 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	6.0% 6/100 • Number of events 6 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders Device Deployment Issue	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders Device Occlusion	2.0% 4/200 • Number of events 4 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders Fatigue	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders General Physical Health Deterioration	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders Medical Device Complication	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders Multi-Organ Failure	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders Non-Cardiac Chest Pain	2.0% 4/200 • Number of events 5 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders Oedema Peripheral	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders Pain	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders Sudden Cardiac Death	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders Thrombosis in device	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders Ulcer	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders Vessel Puncture Site Thrombosis	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Hepatobiliary disorders Bile Duct Stenosis	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Hepatobiliary disorders Bile Duct Stone	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Hepatobiliary disorders Cholangitis	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Hepatobiliary disorders Cholangitis Acute	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Hepatobiliary disorders Cholecystitis	1.5% 3/200 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Hepatobiliary disorders Cholecystitis Chronic	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Hepatobiliary disorders Cholelthiasis	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Hepatobiliary disorders Hepatorenal Failure	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Hepatobiliary disorders Jaundice	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Immune system disorders Hypersensitivity	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Abdominal Abscess	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Appendicitis Perforated	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Bacteraemia	1.0% 2/200 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Bacterial Infection	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Bronchitis	2.0% 4/200 • Number of events 4 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Bronchopneumonia	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Bursitis Infective	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Cellulitis	2.5% 5/200 • Number of events 9 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	3.0% 3/100 • Number of events 4 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Device Related Infection	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Diabetic Foot Infection	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Diverticulitis	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Enfocarditis	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Erysipelas	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Escherichia Sepsis	1.0% 2/200 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations FUNGAEMIA	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations GANGRENE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations GASTROENTERITIS	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations GASTROENTERITIS VIRAL	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations GROIN ABSCESS	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations H1N1 INFLUENZA	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications ACCIDENT	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications ACCIDENTAL OVERDOSE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications ANAEMIA POSTOPERATIVE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications ANIMAL BITE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications ANKLE FRACTURE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications ARTERIAL RESTENOSIS	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	3.0% 3/100 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications ARTERIOVENOUS FISTULA SITE HAEMORRHAGE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications ARTHROPOD BITE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications CONCUSSION	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications CONTUSION	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications CORONARY BYPASS THROMBOSIS	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications FACIAL BONES FRACTURE	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications FALL	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	3.0% 3/100 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications FEMUR FRACTURE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications GASTROINTESTINAL STOMA COMPLICATION	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications GRAFT HAEMORRHAGE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications HAND FRACTURE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications HEPATIC HAEMATOMA	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications HIP FRACTURE	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications MULTIPLE FRACTURES	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications MUSCLE RUPTURE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications OVERDOSE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications PERIPHERAL ARTERIAL REOCCLUSION	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications PERIPHERAL ARTERY RESTENOSIS	12.0% 24/200 • Number of events 33 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	13.0% 13/100 • Number of events 19 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications POST PROCEDURAL HAEMATOMA	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications RIB FRACTURE	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications SPINAL FRACTURE	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications SUBDURAL HAEMATOMA	0.50% 1/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications TENDON RUPTURE	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications TOXICITY TO VARIOUS AGENTS	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications VASCULAR GRAFT COMPLICATION	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications VASCULAR GRAFT OCCLUSION	1.5% 3/200 • Number of events 4 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications VASCULAR PSEUDOANEURYSM	2.5% 5/200 • Number of events 5 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications WOUND	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications WRIST FRACTURE	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Investigations BLOOD GLUCOSE INCREASED	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Investigations BLOOD PRESSURE INCREASED	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Investigations HAEMOGLOBIN DECREASED	1.0% 2/200 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Investigations TROPONIN INCREASED	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Metabolism and nutrition disorders DEHYDRATION	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Metabolism and nutrition disorders DIABETES MELLITUS	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Metabolism and nutrition disorders DIABETIC COMPLICATION	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Metabolism and nutrition disorders DIABETIC KETOACIDOSIS	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Metabolism and nutrition disorders FAILURE TO THRIVE	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Metabolism and nutrition disorders FLUID OVERLOAD	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Metabolism and nutrition disorders GOUT	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Metabolism and nutrition disorders HYPERGLYCAEMIA	1.5% 3/200 • Number of events 5 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Metabolism and nutrition disorders HYPERGLYCAEMIC HYPEROSMOLAR NONKETOTIC SYNDROME	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Metabolism and nutrition disorders HYPOKALAEMIA	2.0% 4/200 • Number of events 4 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Metabolism and nutrition disorders HYPONATRAEMIA	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Metabolism and nutrition disorders HYPOVOLAEMIA	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Metabolism and nutrition disorders MALNUTRITION	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders ARTHRALGIA	4.0% 8/200 • Number of events 8 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders BACK PAIN	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders CERVICAL SPINAL STENOSIS	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders DUPUYTREN'S CONTRACTURE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders LUMBAR SPINAL STENOSIS	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders MOBILITY DECREASED	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	2.0% 4/200 • Number of events 4 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders MYOPATHY	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.50% 1/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders OSTEONECROSIS	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	5.5% 11/200 • Number of events 12 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	3.0% 3/100 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders ROTATOR CUFF SYNDROME	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders SPINAL COLUMN STENOSIS	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders SYNOVIAL CYST	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders SYNOVITIS	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders TENDONITIS	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA OF THE CERVIX	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BONE NEOPLASM	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CERVIX CANCER METASTATIC	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CERVIX CARCINOMA	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON ADENOMA	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATOCELLULAR CARCINOMA	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LARYNGEAL CANCER	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG CANCER METASTATIC	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE IV	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LYMPHOMA	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTATIC MALIGNANT MELANOMA	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEOPLASM PROSTATE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) OESOPHAGEAL ADENOCARCINOMA	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SALIVARY GLAND NEOPLASM	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SMALL CELL LUNG CANCER	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SPLENIC NEOPLASM MALIGNANCY UNSPECIFIED	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF LUNG	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders CAROTID ARTERY OCCLUSION	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders CAROTID ARTERY STENOSIS	3.0% 6/200 • Number of events 10 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	4.0% 4/100 • Number of events 5 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders CARPAL TUNNEL SYNDROME	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders CEREBRAL INFARCTION	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders CEREBROVASCULAR ACCIDENT	2.5% 5/200 • Number of events 6 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders CEREBROVASCULAR DISORDER	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders CERVICAL MYELOPATHY	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders CONVULSION	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	3.0% 3/100 • Number of events 5 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders DIZZINESS	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders DYSARTHRIA	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders ENCEPHALOPATHY	1.5% 3/200 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	4.0% 4/100 • Number of events 4 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders HAEMORRHAGE INTRACRANIAL	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders HEADACHE	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders HEMIPARESIS	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders HYDROCEPHALUS	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders ISCHAEMIC STROKE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders IVTH NERVE PARALYSIS	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders LOSS OF CONSCIOUSNESS	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders PARAESTHESIA	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders POSTICTAL STATE	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders PRESYNCOPE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders RADICULOPATHY	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders STATUS EPILEPTICUS	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders SUBARACHNOID HAEMORRHAGE	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders SYNCOPE	3.5% 7/200 • Number of events 7 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	5.0% 5/100 • Number of events 5 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	2.0% 4/200 • Number of events 4 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders UNRESPONSIVE TO STIMULI	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Psychiatric disorders ALCOHOL ABUSE	0.50% 1/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Psychiatric disorders DEPENDENCE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Psychiatric disorders DEPRESSION	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Psychiatric disorders MENTAL STATUS CHANGES	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Psychiatric disorders PSYCHOTIC DISORDER	0.50% 1/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Psychiatric disorders SUICIDAL IDEATION	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Psychiatric disorders SUICIDE ATTEMPT	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Renal and urinary disorders ACUTE PRERENAL FAILURE	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Renal and urinary disorders HAEMATURIA	0.50% 1/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Renal and urinary disorders INCONTINENCE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Renal and urinary disorders NEPHROLITHIASIS	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Renal and urinary disorders RENAL ARTERY STENOSIS	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Renal and urinary disorders RENAL FAILURE	1.5% 3/200 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Renal and urinary disorders RENAL FAILURE ACUTE	7.0% 14/200 • Number of events 17 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	3.0% 3/100 • Number of events 5 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Renal and urinary disorders RENAL FAILURE CHRONIC	2.0% 4/200 • Number of events 5 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Renal and urinary disorders URINARY RETENTION	1.5% 3/200 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Renal and urinary disorders URINARY TRACT INFLAMMATION	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Reproductive system and breast disorders ERECTILE DYSFUNCTION	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Reproductive system and breast disorders OVARIAN CYST	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY DISTRESS SYNDROME	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	2.0% 4/200 • Number of events 4 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Respiratory, thoracic and mediastinal disorders BRONCHITIS CHRONIC	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Infected Seroma	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Infection	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Influenza	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Lobar Pneumonia	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Pasteurella Infection	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Peritonitis	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Pneumonia	7.0% 14/200 • Number of events 20 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	9.0% 9/100 • Number of events 10 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Sepsis	2.5% 5/200 • Number of events 6 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	4.0% 4/100 • Number of events 4 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Septic Shock	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Staphylococcal Infection	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Staphylococcal Sepsis	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Urinary Tract Infection	3.5% 7/200 • Number of events 9 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	3.0% 3/100 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	1.5% 3/200 • Number of events 4 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	4.0% 4/100 • Number of events 4 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Skin and subcutaneous tissue disorders ANGIOEDEMA	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Skin and subcutaneous tissue disorders DECUBITUS ULCER	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Skin and subcutaneous tissue disorders DERMATITIS CONTACT	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Skin and subcutaneous tissue disorders SKIN ULCER	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Skin and subcutaneous tissue disorders URTICARIA	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Surgical and medical procedures ANGIOPLASTY	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Surgical and medical procedures AORTIC VALVE REPLACEMENT	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Surgical and medical procedures CATARACT OPERATION	0.50% 1/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Surgical and medical procedures KNEE ARTHROPLASTY	1.0% 2/200 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Surgical and medical procedures OBESITY SURGERY	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Surgical and medical procedures PERIPHERAL ARTERY ANGIOPLASTY	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Urinary Tract Infection Bacterial	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Urosepsis	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Viral Infection	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Viral Pharyngitis	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations Viral Upper Respiratory Tract Infection	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Surgical and medical procedures PERIPHERAL ARTERY BYPASS	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Surgical and medical procedures PERIPHERAL REVASCULARISATION	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Surgical and medical procedures RESECTION OF RECTUM	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Surgical and medical procedures SURGERY	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Surgical and medical procedures TOE AMPUTATION	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Surgical and medical procedures WOUND DRAINAGE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders ACCELERATED HYPERTENSION	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders AORTIC ANEURYSM	1.5% 3/200 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders AORTIC STENOSIS	3.0% 6/200 • Number of events 6 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders ARTERIAL OCCLUSIVE DISEASE	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders ARTERIAL STENOSIS	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders BLUE TOE SYNDROME	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders DEEP VEIN THROMBOSIS	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders FEMORAL ARTERY DISSECTION	8.5% 17/200 • Number of events 17 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	6.0% 6/100 • Number of events 6 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders FEMORAL ARTERY OCCLUSION	2.5% 5/200 • Number of events 6 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders HAEMORRHAGE	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders HYPERTENSION	2.5% 5/200 • Number of events 5 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders HYPERTENSIVE CRISIS	1.5% 3/200 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders HYPOTENSION	3.0% 6/200 • Number of events 7 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders INTERMITTENT CLAUDICATION	21.5% 43/200 • Number of events 59 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	18.0% 18/100 • Number of events 23 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders ISCHAEMIA	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders ORTHOSTATIC HYPOTENSION	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	4.5% 9/200 • Number of events 10 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders PERIPHERAL ARTERY DISSECTION	0.00% 0/200 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders PERIPHERAL ARTERY STENOSIS	22.5% 45/200 • Number of events 64 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	27.0% 27/100 • Number of events 42 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders PERIPHERAL ARTERY THROMBOSIS	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders PERIPHERAL EMBOLISM	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders PERIPHERAL ISCHAEMIA	2.0% 4/200 • Number of events 4 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders PERIPHERAL VASCULAR DISORDER	3.0% 6/200 • Number of events 6 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders THROMBOPHLEBITIS SUPERFICIAL	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders THROMBOSIS	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders VARICOSE VEIN	0.50% 1/200 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	1.0% 1/100 • Number of events 1 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders VENOUS INSUFFICIENCY	1.0% 2/200 • Number of events 2 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	0.00% 0/100 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.

Other adverse events

Measure	DCB Subjects n=200 participants at risk The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm. Stellarex 0.035" OTW Drug-coated Angioplasty Balloon: The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.	PTA Subjects n=100 participants at risk The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use. EverCross™ 0.035 PTA Balloon Catheter: The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Blood and lymphatic system disorders Anaemia	8.0% 16/200 • Number of events 21 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	6.0% 6/100 • Number of events 7 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Angina Pectoris	7.0% 14/200 • Number of events 19 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	6.0% 6/100 • Number of events 7 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders Atrial Fibrillation	6.0% 12/200 • Number of events 16 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	11.0% 11/100 • Number of events 20 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	6.5% 13/200 • Number of events 21 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	6.0% 6/100 • Number of events 8 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Cardiac disorders CORONARY ARTERY DISEASE	7.0% 14/200 • Number of events 16 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	5.0% 5/100 • Number of events 6 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Eye disorders CATARACT	1.0% 2/200 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	5.0% 5/100 • Number of events 7 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Gastrointestinal disorders ABDOMINAL PAIN	6.5% 13/200 • Number of events 15 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	6.0% 6/100 • Number of events 6 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders CHEST PAIN	17.5% 35/200 • Number of events 55 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	17.0% 17/100 • Number of events 23 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders LOCAL SWELLING	3.5% 7/200 • Number of events 8 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	10.0% 10/100 • Number of events 13 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
General disorders OEDEMA PERIPHERAL	6.5% 13/200 • Number of events 13 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	11.0% 11/100 • Number of events 13 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations BRONCHITIS	6.0% 12/200 • Number of events 13 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	3.0% 3/100 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations CELLULITIS	4.5% 9/200 • Number of events 13 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	6.0% 6/100 • Number of events 8 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations PNEUMONIA	9.0% 18/200 • Number of events 24 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	10.0% 10/100 • Number of events 11 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Infections and infestations URINARY TRACT INFECTION	10.0% 20/200 • Number of events 25 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	7.0% 7/100 • Number of events 11 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications CONTUSION	8.5% 17/200 • Number of events 23 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	3.0% 3/100 • Number of events 4 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications FALL	2.5% 5/200 • Number of events 8 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	5.0% 5/100 • Number of events 5 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Injury, poisoning and procedural complications PERIPHERAL ARTERY RESTENOSIS	15.0% 30/200 • Number of events 41 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	18.0% 18/100 • Number of events 25 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders ARTHRALGIA	10.0% 20/200 • Number of events 27 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	15.0% 15/100 • Number of events 20 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders BACK PAIN	10.0% 20/200 • Number of events 23 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	9.0% 9/100 • Number of events 11 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	8.0% 16/200 • Number of events 18 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	7.0% 7/100 • Number of events 8 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	5.0% 10/200 • Number of events 10 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	6.0% 6/100 • Number of events 6 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	3.5% 7/200 • Number of events 10 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	7.0% 7/100 • Number of events 7 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	24.0% 48/200 • Number of events 64 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	21.0% 21/100 • Number of events 23 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders CAROTID ARTERY STENOSIS	3.5% 7/200 • Number of events 13 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	6.0% 6/100 • Number of events 7 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders DIZZINESS	5.0% 10/200 • Number of events 12 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	3.0% 3/100 • Number of events 7 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders HEADACHE	5.0% 10/200 • Number of events 15 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 4 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Nervous system disorders SYNCOPE	5.0% 10/200 • Number of events 12 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	7.0% 7/100 • Number of events 7 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Renal and urinary disorders RENAL FAILURE ACUTE	9.5% 19/200 • Number of events 22 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	5.0% 5/100 • Number of events 8 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	5.5% 11/200 • Number of events 29 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	6.0% 6/100 • Number of events 10 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	14.5% 29/200 • Number of events 37 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	11.0% 11/100 • Number of events 19 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	4.0% 8/200 • Number of events 10 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	5.0% 5/100 • Number of events 6 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Skin and subcutaneous tissue disorders RASH	2.0% 4/200 • Number of events 5 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	5.0% 5/100 • Number of events 6 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders FEMORAL ARTERY DISSECTION	8.5% 17/200 • Number of events 19 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	6.0% 6/100 • Number of events 6 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders HAEMATOMA	6.5% 13/200 • Number of events 14 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	3.0% 3/100 • Number of events 3 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders HYPERTENSION	6.0% 12/200 • Number of events 14 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	6.0% 6/100 • Number of events 9 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders HYPOTENSION	5.0% 10/200 • Number of events 14 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	2.0% 2/100 • Number of events 5 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders INTERMITTENT CLAUDICATION	37.0% 74/200 • Number of events 124 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	35.0% 35/100 • Number of events 56 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	6.5% 13/200 • Number of events 16 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	6.0% 6/100 • Number of events 7 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.
Vascular disorders PERIPHERAL ARTERY STENOSIS	27.0% 54/200 • Number of events 98 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.	34.0% 34/100 • Number of events 63 • Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up. The definitions are the same.

Additional Information

Nicolas Aguirre

Philips

Phone: 612-297-6655

Email: nicolas.aguirre@philips.com

Results disclosure agreements

• Principal investigator is a sponsor employee Research Institution and PI shall have the right to publish, present or otherwise publicly disclose the results to their own activity conducted in the trial. Proposals must be submitted to the sponsor for review 30 days prior to publishing submission. Sponsor has the right to require confidentially sensitive information be removed (not including results) and/or delay publication for an additional 60 days.
• Publication restrictions are in place

Restriction type: OTHER