A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Bilirubin status 'Negative' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Bilirubin status 'Positive +' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive +, positive ++, not done (data not available). Positive category (+, ++) indicate worsening from Baseline.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Bilirubin status 'Positive ++' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Blood status 'Negative' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Blood status 'Positive +' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Blood status 'Positive ++' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Blood status 'Trace (H)' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace (H), positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Blood status 'Trace (N)' at baseline are included in the analysis.

Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, \>= 111 mmol/l, not done (data not available).

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Glucose value \>=111 mmol/l at baseline are included in the analysis.

Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, \>= 111 mmol/l, not done (data not available).

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Glucose value 14 mmol/l at baseline are included in the analysis.

Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, \>= 111 mmol/l, not done (data not available).

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Glucose value 28 mmol/l at baseline are included in the analysis.

Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, \>= 111 mmol/l, not done (data not available).

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Glucose value 5.5 mmol/l at baseline are included in the analysis.

Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, \>= 111 mmol/l, not done (data not available).

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Glucose value 55 mmol/l at baseline are included in the analysis.

Categories are as following: negative, 5.5 mmol/l, 14 mmol/l, 28 mmol/l, 55 mmol/l, \>= 111 mmol/l, not done (data not available).

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Glucose value 'Negative' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Ketone status 'Moderate' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Ketone status 'Negative' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Ketone status 'Small' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace (N), trace, small, moderate, not done (data not available).

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Ketone status 'Trace' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive, not done (data not available). Positive category indicate worsening from Baseline.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Nitrite status 'Negative' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, positive, not done (data not available). Positive category indicate worsening from Baseline.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Nitrite status 'Positive' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine pH= 5.0 at baseline are included in this analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine pH= 6.0 at baseline are included in this analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine pH= 6.5 at baseline are included in this analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine pH= 7.0 at baseline are included in this analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine pH= 7.5 at baseline are included in this analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: pH= 5.0, pH= 6.0, pH= 6.5, pH= 7.0, pH= 7.5, pH= 8.0, pH= 8.5, not done (data not available). Baseline value taken at Visit 2 or at screening for parameters not collected at Visit 2. Last visit is the last post-baseline visit observed under exposure of trial medication, including unscheduled visits.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine pH= 8.0 at baseline are included in this analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Protein status 'Negative' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Protein status 'Positive +' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Protein status 'Positive ++' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

Time frame: Last Visit (up to 140 weeks)

Population: Only subjects with Urine Protein status 'Positive +++' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive category (+, ++, +++) indicate worsening from Baseline.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Protein status 'Trace' at baseline are included in the analysis.

Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Urobilinogen value 16 µmol/l at baseline are included in the analysis.

Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Urobilinogen value 3 µmol/l at baseline are included in the analysis.

Categories are as following: 3 µmol/l, 16 µmol/l, 33 µmol/l, 66 µmol/l, not done (data not available).

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with Urine Urobilinogen value 66 µmol/l at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine White Blood Cell Count 'Negative' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine White Blood Cell Count 'Positive +' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine White Blood Cell Count 'Positive ++' at baseline are included in the analysis.

Urinalysis was performed locally at all visits using a urine dipstick test. Categories are as following: negative, trace, positive +, positive ++, positive +++, not done (data not available). Positive categories (+,++,+++) indicate worsening from Baseline.

Time frame: Baseline, Last Visit (up to 140 weeks)

Population: Only subjects with urine White Blood Cell Count 'Trace' at baseline are included in the analysis.

An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

Time frame: During the study period (up to 140 weeks)

Population: The Safety Set was defined as all subjects who signed the informed consent form and took at least 1 dose of trial medication.

Changes in 12-lead ECGs is reported as percentage of subjects with abnormal ECG findings categorized in 'Abnormal, possibly insignificant' and 'Abnormal, possibly significant' based on the alert criterion by the ECG vendor and not on the investigator's assessment.

Time frame: Last Visit (up to 140 weeks)

Population: Only subjects with a last visit assessment who had a normal assessment at Baseline where Baseline is defined as the last ECG assessment prior to the first dose of trial medication are included in the analysis.

An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.

Time frame: From Screening until Safety Follow up Visit (up to 140 weeks)

Population: The Safety Set (SS) was defined as all subjects who signed the informed consent form and took at least 1 dose of trial medication.

Changes in clinical chemistry parameters is reported as incidence of marked abnormalities in - Alanine aminotransferase (\[ALT\] 3x ULN) - Alanine aminotransferase (\[ALT\] 5x ULN) - Alanine aminotransferase \[(ALT\] 10x ULN) - Aspartate aminotransferase (\[AST\] 3x ULN) - Aspartate aminotransferase (\[AST\] 5x ULN) - Aspartate aminotransferase (\[AST\] 10x ULN) - Alkaline Phosphatase (3x ULN) - Gamma-glutamyltransferase (\[GGT\] 3x ULN) - Total Bilirubin (2x ULN) - Albumin (\<26 g/l) - Blood Urea Nitrogen (\>=14.28 mmol/l) - Creatinine (\>=2.0 mg/dl) - Calcium (\<=7.6 or \>=11.0 mg/dl) - Chloride (\<=90 or \>=112 mmol/l) - Phosphorus (\<=2.0 or \>=6.0 mg/dl) - Potassium (\<=3.0 or \>=6.0 mmol/l) - Sodium (\<127 or \>151 mmol/l) - Glucose (\<50 or \>=200 mg/dl) - Total Cholesterol (\>6.5 mmol/l) - Uric Acid (\>565.06 umol/l)

Time frame: During the maintenance period (up to 136 weeks)

Population: Safety Set included 371 subjects. Only subjects with valid data for clinical chemistry parameters are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for different clinical chemistry parameters.

Changes in clinical chemistry parameters is reported as incidence of marked abnormalities in - Alanine aminotransferase (\[ALT\] 3x ULN) - Alanine aminotransferase (\[ALT\] 5x ULN) - Alanine aminotransferase \[(ALT\] 10x ULN) - Aspartate aminotransferase (\[AST\] 3x ULN) - Aspartate aminotransferase (\[AST\] 5x ULN) - Aspartate aminotransferase (\[AST\] 10x ULN) - Alkaline Phosphatase (3x ULN) - Gamma-glutamyltransferase (\[GGT\] 3x ULN) - Total Bilirubin (2x ULN) - Albumin (\<26 g/l) - Blood Urea Nitrogen (\>=14.28 mmol/l) - Creatinine (\>=2.0 mg/dl) - Calcium (\<=7.6 or \>=11.0 mg/dl) - Chloride (\<=90 or \>=112 mmol/l) - Phosphorus (\<=2.0 or \>=6.0 mg/dl) - Potassium (\<=3.0 or \>=6.0 mmol/l) - Sodium (\<127 or \>151 mmol/l) - Glucose (\<50 or \>=200 mg/dl) - Total Cholesterol (\>6.5 mmol/l) - Uric Acid (\>565.06 umol/l)

Time frame: During the titration period (up to Week 8)

Population: Safety Set included 371 subjects. Only subjects with valid data for clinical chemistry parameters are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for different clinical chemistry parameters.

Changes in hematology parameters is reported as incidence of marked abnormalities in - Hematocrit (\<=.85x Lower Limit Normal \[LLN\] or \>= 1.15x Upper Limit Normal \[ULN\] - Hemoglobin (\<=.85x LLN or \>=1.15x ULN) - White Blood Cell (WBC) Count (\<=3.0 or \>=16.0 G/l) - Basophils (\>=5.0%) - Eosinophils (\>=10%) - Monocytes (\>=20%) - Platelet Count (\<=100 or \>=600 G/l)

Time frame: During the maintenance period (up to 136 weeks)

Population: Safety Set included 371 subjects. Only subjects with valid data for hematology parameters are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for different hematologic parameters.

Changes in hematology parameters is reported as incidence of marked abnormalities in - Hematocrit (\<=.85x Lower Limit Normal \[LLN\] or \>= 1.15x Upper Limit Normal \[ULN\] - Hemoglobin (\<=.85x LLN or \>=1.15x ULN) - White Blood Cell (WBC) Count (\<=3.0 or \>=16.0 G/l) - Basophils (\>=5.0%) - Eosinophils (\>=10%) - Monocytes (\>=20%) - Platelet Count (\<=100 or \>=600 G/l)

Time frame: During the titration period (up to Week 8)

Population: Safety Set included 371 subjects. Only subjects with valid data for hematology parameters are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for different hematologic parameters.

Changes in neurological examination findings is reported as percentage of subjects with marked abnormalities in following categories: - General - Cranial Nerves - Reflexes - Muscle Strength and Tone - Coordination and Cerebellar Function - Motor System - Sensation: Upper Extremities - Sensation: Lower Extremities The percentages are based on the number of subjects with examinations done at last visit for each category or parameter.

Time frame: Last Visit (up to 140 weeks)

Population: 371 subjects were included in the safety set. Here, Number analyzed signifies those subjects who were evaluable for prespecified categories.

Changes in physical examination findings is reported as percentage of subjects with marked abnormalities in following categories: - Ears, Eyes, Nose, Mouth, Throat - Cardiovascular - Peripheral vascular - Pulmonary - Musculoskeletal - Hepato- / Gastrointestinal - Renal / Genitourological - Neurological - Metabolic / Endocrine - Psychiatric - Hematological / Lymphatic Nodes - Dermatological - Other The percentages are based on the number of subjects with examinations done at each visit for each body system.

Time frame: Last Visit (up to 140 weeks)

Population: 371 subjects were included in the safety set. Here, Number analyzed signifies those subjects who were evaluable for prespecified categories.

Changes in vital signs examination findings is reported as percentage of subjects with marked abnormalities in - Systolic Blood Pressure (SBP) \>=180 mmHg and increase of \>=20 mmHg - Systolic Blood Pressure \>=90 mmHg and decrease of \>=20 mmHg - Diastolic Blood Pressure (DBP) \>=105 mmHg and increase of \>=15 mmHg - Diastolic Blood Pressure \>=50 mmHg and decrease of \>=15 mmHg - Pulse Rate (PR) \>=120 beats/min and increase of \>=15 beats/min - Pulse Rate \>=50 beats/min and decrease of \>=15 beats/min

Time frame: During study period (up to 140 weeks)

Pain interference scores at each visit (sleep and activity respectively) were defined as the average of the respective daily interference scores during the 7 last available days prior to the corresponding visit. An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement in symptoms from Baseline. Subjects rated pain interference over the past 12 hours for 7 days prior to each visit and an average value was calculated for each subject.

Time frame: Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9

Population: 371 subjects were included in the Safety set. Only subjects with available data for Pain Interference with general activity at the respective visit are included in the analysis. Here, Number analyzed signifies those subjects who were who were evaluable for each visit.

Pain interference scores at each visit (sleep and activity respectively) were defined as the average of the respective daily interference scores during the 7 last available days prior to the corresponding visit. An 11-point Likert scale was used to assess the subject's sleep. The subject rated how the pain had interfered with sleep over the past 12 hours, from 0 (no interference) to 10 (complete interference). A negative value indicates improvement in symptoms from Baseline. Subjects rated pain interference over the past 12 hours for 7 days prior to each visit and an average value was calculated for each subject.

Time frame: Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9

Population: 371 subjects were included in the Safety set. Only subjects with available data for Pain Interference with sleep at the respective visit are included in the analysis. Here, Number analyzed signifies those subjects who were evaluable for each visit.

A 100 mm visual analogue scale (VAS) was used to assess the subject's current pain. The subject rated their current pain from 0 (no pain) to 100 (worst possible pain). A negative value indicates improvement in symptoms.

Time frame: Baseline, Visit 2.1, Visit 2.2, Visit 2.4, Visit 2.5, Visit 3, Visit 4, Visit 5, Visit 6, Visit 7, Visit 8, Visit 9.0, Visit 9.1, Visit 9.2, Visit 9.3, Visit 9.4, Visit 9.5, Visit 9.6, Visit 9.7, Visit 9.8, Visit 9.9

Population: 371 subjects were included in the Safety set. Only subjects with available data for current pain measured by a 100 mm visual analogue scale (VAS) at the respective visit are included in the analysis. Here, Number of subjects analyzed signifies those subjects who were evaluable for each visit.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Baseline, Termination Visit (last treatment visit)

Population: 371 subjects were included in the Safety Set. Only patients with available data for different symptoms of neuropathic pain are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the Neuropathic Pain Symptoms Inventory (NPSI) at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Baseline, Visit 4

Population: 371 subjects were included in the Safety Set. Only patients with available data for different symptoms of neuropathic pain are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Baseline, Visit 6

Population: Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Baseline, Visit 9.0

Population: 371 subjects were included in the Safety Set. Only patients with available data for different symptoms of neuropathic pain are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain), and are reported in categories below and 2 temporal questions (duration of pain, number of pain attacks). This assessment was done only in subjects from countries in which a validated version of the NPSI was available. Total NPSI scale ranged from 0 (no pain) to 100 (maximum pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline.

Time frame: Baseline, Visit 9.1

Population: Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Baseline, Visit 9.2

Population: 371 subjects were included in the Safety Set. Only patients with available data for different symptoms of neuropathic pain are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Baseline, Visit 9.3

Population: Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Baseline, Visit 9.4

Population: Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Baseline, Visit 9.5

Population: Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Baseline, Visit 9.6

Population: Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Baseline, Visit 9.7

Population: Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Subjects were asked to assess different symptoms of neuropathic pain with respect to severity using the NPSI at different visits. It comprised of 10 descriptive symptom questions (pain feels like burning, squeezing, pressure electric shocks, stabbing, pins/needles, tingling, provoked or increased by brushing, pressure or contact with something cold), and 2 temporal questions (duration of pain, number of pain attacks). The NPSI scores of the descriptive questions are reported in categories below, which were rated on an 11-point scale from 0 (absence of pain) to 10 (maximum intensity of pain). Higher scores indicate a greater intensity of pain. A negative value indicates improvement in symptoms from Baseline. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Baseline, Visit 9.8

Population: Only patients with available data for different symptoms of neuropathic pain are included in the analysis.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Time frame: Baseline, Termination Visit (last treatment visit)

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the Short Form-36 (SF-36) Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the physical component Summary (PCS) score of the SF-36. Items 5-8 primarily contribute to the mental component summary (MCS) score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Time frame: Baseline, Visit 4

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Time frame: Baseline, Visit 6

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Time frame: Baseline, Visit 9.0

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Time frame: Baseline, Visit 9.1

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Time frame: Baseline, Visit 9.2

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Time frame: Baseline, Visit 9.3

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Time frame: Baseline, Visit 9.4

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Time frame: Baseline, Visit 9.5

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Time frame: Baseline, Visit 9.6

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Time frame: Baseline, Visit 9.7

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

Quality of life was analyzed using the SF-36 Health Survey quality of life questionnaire. The SF-36 is a participant self-rated questionnaire which consists of 8 sub-scores ranging from 0-100 with higher scores indicating a better health state. The sub-scores are: 1. Physical Functioning, 2. Role-Physical, 3. Bodily Pain, 4. General Health, 5. Vitality, 6. Social Functioning, 7. Role-Emotional, 8. Mental Health. Items 1-4 primarily contribute to the PCS score of the SF-36. Items 5-8 primarily contribute to the MCS score of the SF-36. The PCS and MCS were based on the standardized values of the 8 domains. The maximum and minimum possible values for PCS and MCS is 0-100, where higher scores indicate good condition. A positive value indicates improvement from baseline in quality of life.

Time frame: Baseline, Visit 9.8

Population: 371 subjects were included in the Safety Set. Only patients with available data for different sub-scores of SF-36 are included in the analysis. Here, Number Analyzed signifies those subjects who were evaluable at prespecified categories.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Time frame: Termination Visit (last treatment visit)

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Time frame: Visit 4

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Time frame: Visit 6

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Time frame: Visit 9.0

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Time frame: Visit 9.1

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Time frame: Visit 9.2

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Time frame: Visit 9.3

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Time frame: Visit 9.4

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Time frame: Visit 9.5

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Time frame: Visit 9.6

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Time frame: Visit 9.7

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

The PGIC is a 7-point categorical rating scale in which the subject rates the change in his/her pain since starting trial medication. Categories are as following: much worse, moderately worse, mildly worse, no change, mildly better, moderately better, much better.

Time frame: Visit 9.8

Population: Only patients with available data for Patient's Global Impression of Change in Pain (PGIC) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Termination Visit (last treatment visit)

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 2 (Baseline)

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 4

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 6

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 9.0

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 9.1

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 9.2

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 9.3

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 9.4

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 9.5

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 9.6

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 9.7

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Pain attacks were analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of number of pain attacks are as following: no pain attack, between 1 and 5, between 6 and 10, between 11 and 20, more than 20, not done (data not available). This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 9.8

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Termination Visit (last treatment visit)

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 2 (Baseline)

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 4

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 6

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 9.0

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 9.1

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 9.2

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 9.3

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 9.4

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 9.5

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 9.6

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 9.7

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.

Presence of spontaneous pain was analyzed using the Neuropathic Pain Symptom Inventory (NPSI). This questionnaire comprises 10 descriptive questions, which are rated on 0 to 10 point scales, and 2 temporal questions. Categories of duration of pain are as following: permanently, between 8 and 12 h, between 4 and 7 h, between 1 and 3 h, Less than 1 h. This assessment was done only in subjects from countries in which a validated version of the NPSI was available.

Time frame: Visit 9.8

Population: Only patients with available data for Neuropathic Pain Symptom Inventory (NPSI) are included in the analysis.