MAE is defined as any device-related or index procedure-related death within 30 days, myocardial infarction during index hospitalization, target vessel revascularization through 9 months, or amputation of the index limb through 9 months

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.

Death is classified as follows. Cardiac death: death due to immediate cardiac cause, death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.

Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.

Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 11 participants were not evaluable.

Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 17 participants were not evaluable.

Death is classified as follows. Cardiac death: death due to immediate cardiac cause; death of unknown cause is classified as cardiac death, including all procedure related deaths including those related to concomitant treatment; Vascular death: death due to cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause; Non-cardiovascular death: any death not covered by the above definitions

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 18 participants were not evaluable.

Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.

Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.

Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.

Major amputation: amputation of the lower limb at the ankle level or above Minor amputation: amputation of forefoot or toes

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 25 participants were not evaluable.

Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.

A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.

Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.

A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.

Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.

A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.

Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.

A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.

Target vessel revascularization (TVR) is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure. A TVR is considered ischemia-driven if the culprit lesion stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms.

A TVR is considered ischemia-driven if the culprit lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable.

Definition of myocardial infarction: New Q-waves in ≥2 leads lasting ≥0.04 sec with creatine kinase- myoglobin band (CK-MB)/troponin above upper limit of normal (ULN); if no new Q-waves elevation of post-procedure CK levels >2.0× ULN with positive CK-MB, or, if the assay for CK-MB was not performed, elevation of CK levels >2.0× ULN with positive troponin. Drawing a CK-MB or troponin is mandated if CK is greater than 2× ULN. If no CK-MB or troponin was drawn, CK >2× ULN will be considered an MI. ULN is determined per local laboratory specifications.

Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint

Residual lesion stenosis <=30% based on visual assessment immediately postprocedure

Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint

Technical success (residual lesion stenosis <=30% based on visual assessment immediately postprocedure) and no in-hospital major adverse events (device- or index procedure-related death, myocardial infarction, target vessel revascularization or amputation of the index limb).

Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint

Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:

Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable

Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:

Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable

Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:

Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint. There were 16 participants not evaluable.

Improvement in Rutherford classification by 1 class as compared to baseline. Rutherford Classification is used to assess lower extremity ischemia as shown below:

Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint. There were 19 participants not evaluable.

Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable.

Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 12 participants were not evaluable.

Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 8 participants were not evaluable.

Improvement in ankle-brachial index (ABI) by ≥0.1 from the pre-procedure value and not deteriorated by >0.15 from the maximum post-procedure value. Reported per limb.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 11 participants were not evaluable.

Rutherford Classification is used to assess lower extremity ischemia as shown below:

0 = Asymptomatic

1. = Mild claudication
2. = Moderate claudication
3. = Severe claudication
4. = Ischemic rest pain
5. = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema

Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint

Rutherford Classification is used to assess lower extremity ischemia as shown below:

0 = Asymptomatic

1. = Mild claudication
2. = Moderate claudication
3. = Severe claudication
4. = Ischemic rest pain
5. = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema

Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint; 12 participants were not evaluable.

Rutherford Classification is used to assess lower extremity ischemia as shown below:

0 = Asymptomatic

1. = Mild claudication
2. = Moderate claudication
3. = Severe claudication
4. = Ischemic rest pain
5. = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema

Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint; 12 participants were not evaluable.

Rutherford Classification is used to assess lower extremity ischemia as shown below:

Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; there were 16 participants not evaluable.

Rutherford Classification is used to assess lower extremity ischemia as shown below:

Class 0 = Asymptomatic Class 1 = Mild claudication Class 2 = Moderate claudication Class 3 = Severe claudication Class 4 = Ischemic rest pain Class 5 = Minor tissue loss - non-healing ulcer, focal gangrene with diffuse pedal edema Class 6 = Major tissue loss

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; there were 19 participants not evaluable.

Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion

Acute stent thrombosis is defined as occurring <=24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to <=30 days following the trial procedure.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.

Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion

Acute stent thrombosis is defined as occurring less than or equal to 24 hours following the trial procedure. Subacute stent thrombosis is defined as occurring >24 hours to less than or equal to 30 days following the trial procedure.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable

Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion

Late stent thrombosis is defined as >30 days to 365 days following the trial procedure.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable

Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion

Late stent thrombosis is defined as >30 days to 365 days following the trial procedure.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable

Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion

Very late stent thrombosis is defined as >365 days following the trial procedure.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable

Angiographic documentation of an acute, complete occlusion of a previously successfully treated lesion and/or Angiographic documentation of a flow-limiting thrombus within, or adjacent to, a previously successfully treated lesion

Very late stent thrombosis is defined as >365 days following the trial procedure.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable

Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.

Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 7 participants were not evaluable.

Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 13 participants were not evaluable.

Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 19 participants were not evaluable.

Target lesion revascularization (TLR) is any surgical or percutaneous intervention to the target lesion(s) after the index procedure. A TLR will be considered ischemia-driven if the target lesion diameter stenosis is ≥50% by quantitative angiography and the subject has ischemic symptoms. A TLR will be considered ischemia-driven if the lesion diameter stenosis is ≥70% even in the absence of clinical or functional ischemia.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 24 participants were not evaluable.

Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:

Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.

Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.

Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint

Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:

Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.

Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.

Analysis was intention to treat; all participants in the study were evaluated to provide the information needed for this endpoint

Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:

Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.

Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 4 participants were not evaluable.

Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:

Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.

Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.

Ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm as follows:

Ankle: The systolic pressure will be measured in the index limb at the arteria dorsalis pedis and/or the arteria tibialis posterior. If both pressures are measured, the highest pressures will be used for the ABI calculation.

Brachial: The systolic pressure will be measured in both arms, and the highest of both pressures will be used for the ABI calculation.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.

Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable

Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization, bypass of the target lesion, or amputation.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable

Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable.

Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Primary-assisted patency (defined per lesion) is defined as DUS SVR ≤2.5 with no target lesion revascularization for total occlusion, bypass of the target lesion, or amputation. In 1 subject, SVR was invalid and DUS proximal peak systolic velocity was analyzed to assess restenosis.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable.

Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR ≤2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 31 participants were not evaluable

Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Secondary patency (defined per lesion) is defined as having DUS SVR ≤2.5 in the absence of bypass of the target lesion or amputation. In 1 subject, SVR was invalid and proximal peak systolic velocity was analyzed to assess restenosis.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable

Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 30 participants were not evaluable.

Systolic velocity ratio (SVR) is the ratio of the measurement of systolic velocity in 2 arterial regions as determined by duplex ultrasound (DUS). Restenosis (defined per lesion)is defined as DUS SVR >2.5 or the presence of a target lesion revascularization prior to the DUS examination, regardless of the SVR value. In 1 subject, SVR was invalid and proximal peak systolic velocity by DUS was analyzed to assess restenosis.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 50 participants were not evaluable.

The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.

Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.

The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.

The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.

The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.

Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.

The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 15 participants were not evaluable.

The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.

Analysis was intention to treat; all participants in the study were to undergo clinical follow up to provide the information needed for this endpoint; 16 participants were not evaluable.

The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.

Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; one participant was not evaluable.

The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.

Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; 15 participants were not evaluable.

The Walking Impairment Questionnaire is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score.

Analysis was intention to treat; all participants in the study were to be evaluated to provide the information needed for this endpoint; 17 participants were not evaluable.