Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).

Intent to treat (ITT) population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).

Intent to treat (ITT) population. Included 192 study stents implanted plus 1 study stent inserted in subjects vasculature, but not implanted due to device malfunction. 1 study stent was excluded from device success because the chosen size was not appropriate, therefore the stent was not implanted.

Technical success is defined, on per target lesion basis, device success and attainment of a final in-stent residual stenosis of < 30% by QA or as reported by the investigator, if QA is not available.

ITT population

Procedure success is defined, per patient basis, as technical success without any of the following complications; death due to all causes, myocardial infarction (MI), major amputation of the treated limb(s), stent thrombosis and target lesion revascularization (TLR) within two (2) days after the index procedure or at hospital discharge, whichever is sooner.

ITT population

The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

Per target limb analysis.ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.

Per target limb analysis. ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best).

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point. The highest score for each domain is 100%, which indicates no difficulty.Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

Measured by the Walking Impairment Questionnaire (WIQ)

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

Measured by the Walking Impairment Questionnaire (WIQ)

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.The highest score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.

The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.

Category and Clinical Description:

0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.

Category and Clinical Description:

0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.

Category and Clinical Description:

0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.

Category and Clinical Description:

0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

The Rutherford Becker clinical category is a scale to measure chronic limb ischemia.

Category and Clinical Description:

0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Change in Rutherford Becker Clinical Category:

Worsening Rutherford Becker Clinical Category:

Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.

Improved Rutherford Becker Clinical Category:

An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Change in Rutherford Becker Clinical Category:

Worsening Rutherford Becker Clinical Category:

Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.

Improved Rutherford Becker Clinical Category:

An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Change in Rutherford Becker Clinical Category:

Worsening Rutherford Becker Clinical Category:

Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.

Improved Rutherford Becker Clinical Category:

An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Change in Rutherford Becker Clinical Category:

Worsening Rutherford Becker Clinical Category:

Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6.

Improved Rutherford Becker Clinical Category:

An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by duplex ultrasonography (DUS) or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).

ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.

Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).

ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.

Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).

ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.

Target lesion revascularization was defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).

ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.

Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).

ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.

Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).

ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.

Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).

ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.

Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has <50% stenosis, while treating a non-target lesion in the target vessel).

ITT population.This analysis represents those subjects with target lesions who were event free at this timepoint.

Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)

ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.

Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)

ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.

Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)

ITT population. This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.

Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) defined: Any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel.)

ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.

Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).

ITT population. This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.

Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).

ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.

Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).

ITT population.This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.

Revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).

ITT population. This analysis represents those subjects with lesions in the target vessel who were event free at this timepoint.

Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).

ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.

Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).

ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.

Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).

ITT population. This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.

Any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).

ITT population.This analysis represents those subjects with vessels in the extremity with the target lesions, who were event free at this timepoint.

Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.

ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.

ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.

ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.

ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Defined as ≥ 50% stenosis at follow-up.

ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Defined as ≥ 50% stenosis at follow-up.

ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Defined as ≥ 50% stenosis at follow-up.

ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years

ITT population. This analysis represents those subjects who were event free at this time point.

Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years

ITT population. This analysis represents those subjects who were event free at this time point.

Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years

ITT population.This analysis represents those subjects who were event free at this time point.

Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years

ITT population. This analysis represents those subjects who were event free at this time point.

The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.

ITT population.This analysis represents those subjects who were event free at this time point.

The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.

ITT population.This analysis represents those subjects who were event free at this time point.

The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.

ITT population.This analysis represents those subjects who were event free at this time point.

The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.

ITT population.This analysis represents those subjects who were event free at this time point.

Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

ITT population.This analysis represents those subjects with target limbs who were event free at this time point.

Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

ITT population.This analysis represents those subjects with target limbs who were event free at this time point.

Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

ITT population.This analysis represents those subjects with target limbs who were event free at this time point.

Amputation is defined as the removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle; a major amputation will be defined as at or above the ankle.

ITT population.This analysis represents those subjects with target limbs who were event free at this time point.

Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.

ITT population.This analysis represents those subjects who were event free at this time point.

Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery

ITT population.This analysis represents those subjects who were event free at this time point.

Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery

ITT population.This analysis represents those subjects who were event free at this time point.

Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery

ITT population.This analysis represents those subjects who were event free at this time point.

Stent thrombosis is defined as a total occlusion documented by DUS and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.

ITT population.The number of participants analyzed includes the subjects with available follow-up data at that time-point.

This measure indicates the absolute change between two timepoints represented by the mean.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

This measure indicates the absolute change between two timepoints represented by the mean.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

This measure indicates the absolute change between two timepoints represented by the mean.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

This measure indicates the absolute change between two timepoints represented by the mean.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

This measure indicates the absolute change between two timepoints represented by the mean.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

This measure indicates the absolute change between two timepoints represented by the mean.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

This measure indicates the absolute change between two timepoints represented by the mean.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.

This measure indicates the absolute change between two timepoints represented by the mean.

SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.

ITT population. The number of participants analyzed includes the subjects with available follow-up data at that time-point.