Trial Outcomes & Findings for Long-Term Safety Study of Retigabine Immediate Release (IR) as Adjunctive Therapy in the Treatment of Adults With Partial-Onset Seizures (POS) (NCT NCT01336621)

Last Updated: 2020-03-11

Results Overview

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect or is associated with liver injury or impaired liver function. TEAE refers to an AE for which the onset was on or after the date of the first retigabine dose in this study and on or before 30 days after the last retigabine dose date. AEs that started in the parent study that increased in severity during this study were also considered treatment-emergent. The analysis was performed on Safety Population, which included participants who took at least one dose of study medication after they had enrolled into this OLE study.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

98 participants

Primary outcome timeframe

Up to 5.8 years

Results posted on

2020-03-11

Participant Flow

Participants with partial-onset seizures (POS) who successfully completed the 20 weeks of treatment in parent study NCT01336621 were recruited in this open-label extension (OLE) study. The study was conducted in two periods, a primary treatment phase and a safety follow-up continuation phase (SFUCP).

Screening was performed on the same day as the final visit of the parent study NCT01336621. A total of 98 participants completed the parent study and opted to enter into this study. All participants received at least one dose of retigabine immediate release (IR) tablets.

Participant milestones

Participant milestones
Measure	Retigabine IR Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Primary Reporting Phase (Upto 5.8 Years) STARTED	98
Primary Reporting Phase (Upto 5.8 Years) COMPLETED	0
Primary Reporting Phase (Upto 5.8 Years) NOT COMPLETED	98
SFUCP (up to 2.6 Years) STARTED	9
SFUCP (up to 2.6 Years) COMPLETED	0
SFUCP (up to 2.6 Years) NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Retigabine IR Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Primary Reporting Phase (Upto 5.8 Years) Adverse Event	11
Primary Reporting Phase (Upto 5.8 Years) Lack of Efficacy	2
Primary Reporting Phase (Upto 5.8 Years) Protocol Violation	12
Primary Reporting Phase (Upto 5.8 Years) Withdrawal by Subject	27
Primary Reporting Phase (Upto 5.8 Years) Other: study terminated	11
Primary Reporting Phase (Upto 5.8 Years) Physician Decision	2
Primary Reporting Phase (Upto 5.8 Years) Other: Reached stopping criteria	22
Primary Reporting Phase (Upto 5.8 Years) Other: lost to follow up	2
Primary Reporting Phase (Upto 5.8 Years) Other: Continued in SFUCP	9
SFUCP (up to 2.6 Years) Other: Reached stopping criteria	1
SFUCP (up to 2.6 Years) Adverse Event	1
SFUCP (up to 2.6 Years) Withdrawal by Subject	3
SFUCP (up to 2.6 Years) Physician Decision	1
SFUCP (up to 2.6 Years) Other: Study closed/terminated	3

Baseline Characteristics

Long-Term Safety Study of Retigabine Immediate Release (IR) as Adjunctive Therapy in the Treatment of Adults With Partial-Onset Seizures (POS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Age, Continuous	39.2 Years STANDARD_DEVIATION 13.19 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Race/Ethnicity, Customized Race customized · Asian: South East Asian Heritage	8 Participants n=5 Participants
Race/Ethnicity, Customized Race customized · White- White/Caucasian/ European Heritage	90 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5.8 years

Population: Safety Population

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (TESAEs): Safety Population Any TEAE	38 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious AEs (TESAEs): Safety Population Any TESAE	4 Participants

PRIMARY outcome

Timeframe: Up to 2.6 years

Population: All SFUCP subjects

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect or is associated with liver injury or impaired liver function. The following AEs were collected in the SFUCP: AEs related to the finding(s) of pigmentation/, discoloration of the eye/skin, AEs related to unexplained vision loss, SAEs, Deaths and Pregnancies. SFUCP collected AEs are those for which onset was 31 days or more after the last dose of retigabine. The analysis was performed on the All SFUCP Subjects population which comprised of all subjects who enter the SFUCP.

Outcome measures

Outcome measures
Measure	Retigabine IR n=9 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants With AEs and SAEs: All SFUCP Subjects Any AE	3 Participants
Number of Participants With AEs and SAEs: All SFUCP Subjects Any SAE	1 Participants

PRIMARY outcome

Timeframe: Up to 5.8 years

Population: Safety Population

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants Withdrawn Due to TEAEs	16 Participants

PRIMARY outcome

Timeframe: Up to 5.8 years

Population: Safety Population. Only those participants with \>=1 ophthalmology exam on or before last dose of RTG are presented.

Number of participants with abnormal findings after eye examination were evaluated. Only retinal pigmentary abnormalities detected on-treatment with retigabine were presented. Retinal pigmentary abnormalities included abnormalities in the macula, peripheral retina and unspecified location.

Outcome measures

Outcome measures
Measure	Retigabine IR n=53 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants With Retinal Pigmentary Abnormalities	8 Participants

PRIMARY outcome

Timeframe: Up to 5.8 years

Population: Safety Population. Only those participants with \>=1 ophthalmology exam on or before last dose of RTG are presented.

Number of participants with abnormal findings after eye examination were evaluated. Pigmentation of non-retinal ocular tissue (s) detected on-treatment with retigabine were presented. Non-retinal pigmentary abnormalities included abnormalities in the sclera and/ or conjunctiva, cornea, iris and lens.

Outcome measures

Outcome measures
Measure	Retigabine IR n=53 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants With Pigmentation of Non-retinal Ocular Tissue(s)	15 Participants

PRIMARY outcome

Timeframe: Up to 5.8 years

Population: Safety Population. Only those participants who had at least one skin exam by the investigator or dermatologist on or before the last dose of RTG or dermatologist-confirmed discoloration with start date on or before the date of last dose of RTG are presented.

Number of participants with Dermatologist-Confirmed abnormal discoloration of skin including skin around the eyes and eyelids, lips, nails, or mucosa were evaluated. Only abnormalities occurring on-treatment with retigabine were presented.

Outcome measures

Outcome measures
Measure	Retigabine IR n=58 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants With Abnormal Discoloration of Skin Any abnormal discoloration	11 Participants
Number of Participants With Abnormal Discoloration of Skin Discoloration of skin	5 Participants
Number of Participants With Abnormal Discoloration of Skin Discoloration of lips	3 Participants
Number of Participants With Abnormal Discoloration of Skin Discoloration of nails	10 Participants
Number of Participants With Abnormal Discoloration of Skin Discoloration of mucosa	9 Participants

PRIMARY outcome

Timeframe: Up to 5.8 years

Population: Safety Population. Only those participants with both initial and at least 1 follow-up exam while on RTG treatment are presented.

Number of participants with a clinically significant decrease in visual acuity from initial examination were evaluated. Only abnormalities occurring on-treatment with retigabine were presented.

Outcome measures

Outcome measures
Measure	Retigabine IR n=48 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination	3 Participants

PRIMARY outcome

Timeframe: Up to 5.8 years

Population: Safety Population. Only those subjects with both initial and at least 1 follow-up exam while on RTG treatment are presented.

Number of participants with a clinically significant decrease in confrontational visual field from initial examination were evaluated. Only abnormalities occurring on-treatment with retigabine were presented.

Outcome measures

Outcome measures
Measure	Retigabine IR n=48 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants With Decrease in Confrontational Visual Field From Initial Examination	1 Participants

PRIMARY outcome

Timeframe: Up to 5.8 years

Population: Safety Population

Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured after at least 5 minutes of rest. Body weight was measured without shoes and wearing light clothing. Baseline assessments in this OLE study were defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was calculated by subtracting the Baseline value from the post-baseline value. Increase or decrease of \>=20 in SBP, increase or decrease of \>=15 in DBP and HR were considered as PCC values. Number of participants with PCC values of vital signs for any visit post-Baseline are presented.

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight Weight; increase of >=7 percent	32 Participants
Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight DBP; decrease of >=15	15 Participants
Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight DBP; increase of >=15	7 Participants
Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight HR; decrease of >=15	15 Participants
Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight HR; increase of >=15	18 Participants
Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight SBP; decrease of >=20	18 Participants
Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight SBP; increase of >=20	8 Participants
Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline in Vital Signs and Weight Weight; decrease of >=7 percent	10 Participants

PRIMARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

Single measurements of 12-lead ECG were obtained in supine position after at least 10 minutes of rest using an ECG machine to measure HR. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Visit 1 (Screening); n= 89	-2.2 Beats per minute (bpm) Standard Deviation 10.54
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Visit 2 (Week 13); n= 90	-0.6 Beats per minute (bpm) Standard Deviation 9.77
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Visit 3 (Week 26); n= 80	-1.5 Beats per minute (bpm) Standard Deviation 9.21
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Visit 4 (Week 39); n= 71	-1.7 Beats per minute (bpm) Standard Deviation 8.72
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Visit 5 (Week 52); n= 67	-0.6 Beats per minute (bpm) Standard Deviation 10.30
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Visit 6 (Week 69); n= 63	-0.2 Beats per minute (bpm) Standard Deviation 9.96
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Visit 7 (Week 86); n= 56	1.6 Beats per minute (bpm) Standard Deviation 8.89
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Visit 8 (Week 104); n= 42	-1.8 Beats per minute (bpm) Standard Deviation 10.30
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Visit 9 (Week 121); n= 38	1.7 Beats per minute (bpm) Standard Deviation 11.01
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Visit 10 (Week 138); n= 37	1.6 Beats per minute (bpm) Standard Deviation 12.17
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Visit 11 (Week 156); n= 30	1.1 Beats per minute (bpm) Standard Deviation 10.23
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Visit 12 (Week 173); n= 24	-0.8 Beats per minute (bpm) Standard Deviation 13.43
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Visit 13 (Week 190); n= 19	2.7 Beats per minute (bpm) Standard Deviation 11.29
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Visit 14 (Week 208); n= 10	5.6 Beats per minute (bpm) Standard Deviation 10.41
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Visit 15 (Week 225); n= 5	-0.2 Beats per minute (bpm) Standard Deviation 8.04
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Visit 16 (Week 242); n= 4	-4.3 Beats per minute (bpm) Standard Deviation 13.30
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Visit 17 (Week 260); n= 4	-7.3 Beats per minute (bpm) Standard Deviation 6.95
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Visit 18 (Week 277); n= 2	2.5 Beats per minute (bpm) Standard Deviation 9.19
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Withdrawal visit; n= 83	-1.8 Beats per minute (bpm) Standard Deviation 11.49
Change From Baseline in Electrocardiogram (ECG) Parameter Including HR Follow up visit; n= 59	-1.1 Beats per minute (bpm) Standard Deviation 11.95

PRIMARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

Single measurements of 12-lead ECG were obtained in supine position after at least 10 minutes of rest using an ECG machine to measure parameters including PR interval, QRS duration, uncorrected QT interval, QTcB, QTcF and RR interval. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; Visit 9 (Week 121); n= 38	-1.1 Milliseconds (msec) Standard Deviation 12.79
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; Visit 10 (Week 138); n= 37	1.2 Milliseconds (msec) Standard Deviation 15.13
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval; Visit 4 (Week 39); n= 69	9.3 Milliseconds (msec) Standard Deviation 23.77
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval; Visit 5 (Week 52); n= 65	6.6 Milliseconds (msec) Standard Deviation 25.18
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval; Visit 18 (Week 277);n= 2	-3.5 Milliseconds (msec) Standard Deviation 36.06
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval; withdrawal visit; n= 80	5.2 Milliseconds (msec) Standard Deviation 29.01
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; visit 10 (Week 138); n= 37	-19.6 Milliseconds (msec) Standard Deviation 145.64
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; visit 15 (Week 225); n= 5	-2.8 Milliseconds (msec) Standard Deviation 108.30
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; Visit 1 (Screening); n= 86	2.4 Milliseconds (msec) Standard Deviation 13.11
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; Visit 2 (Week 13); n= 88	1.3 Milliseconds (msec) Standard Deviation 15.42
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; Visit 3 (Week 26); n= 78	3.2 Milliseconds (msec) Standard Deviation 12.99
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; Visit 4 (Week 39); n= 70	1.2 Milliseconds (msec) Standard Deviation 13.25
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; visit 5 (Week 52); n= 66	-0.2 Milliseconds (msec) Standard Deviation 13.17
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; Visit 6 (Week 69); n= 62	1.3 Milliseconds (msec) Standard Deviation 13.93
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; Visit 7 (Week 86); n= 54	-0.7 Milliseconds (msec) Standard Deviation 12.58
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; Visit 8 (Week 104); n= 42	3.1 Milliseconds (msec) Standard Deviation 10.85
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; Visit 11 (Week 156); n= 30	-0.5 Milliseconds (msec) Standard Deviation 13.50
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; Visit 12 (Week 173); n= 24	4.8 Milliseconds (msec) Standard Deviation 11.89
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; Visit 13 (week 190); n= 19	-2.1 Milliseconds (msec) Standard Deviation 10.19
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; Visit 14 (Week 208); n= 10	7.8 Milliseconds (msec) Standard Deviation 15.03
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; Visit 15 (Week 225); n= 5	8.4 Milliseconds (msec) Standard Deviation 7.23
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; Visit 16 (Week 242); n= 4	-3.0 Milliseconds (msec) Standard Deviation 8.04
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; Visit 17 (Week 260); n= 4	9.3 Milliseconds (msec) Standard Deviation 11.09
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; Visit 18 (Week 277); n= 2	-5.5 Milliseconds (msec) Standard Deviation 7.78
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; Withdrawal visit; n= 81	3.6 Milliseconds (msec) Standard Deviation 13.86
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval PR interval; follow up visit; n= 57	3.7 Milliseconds (msec) Standard Deviation 12.43
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; Visit 1 (Screening); n= 88	-0.1 Milliseconds (msec) Standard Deviation 6.37
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; Visit 2 (Week 13); n= 89	0.2 Milliseconds (msec) Standard Deviation 6.99
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; Visit 3 (Week 26); n= 80	1.1 Milliseconds (msec) Standard Deviation 8.77
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; Visit 4 (Week 39); n= 71	1.1 Milliseconds (msec) Standard Deviation 7.10
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; Visit 5 (Week 52); n= 67	0.9 Milliseconds (msec) Standard Deviation 9.81
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; Visit 6 (Week 69); n= 63	1.9 Milliseconds (msec) Standard Deviation 8.56
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; Visit 7 (Week 86); n= 55	-0.4 Milliseconds (msec) Standard Deviation 7.20
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; Visit 8 (Week 104); n= 42	0.1 Milliseconds (msec) Standard Deviation 6.40
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; Visit 9 (Week 121); n= 38	-0.7 Milliseconds (msec) Standard Deviation 7.79
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; Visit 10 (Week 138); n= 37	-2.0 Milliseconds (msec) Standard Deviation 7.85
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; Visit 11 (Week 156); n= 30	-3.3 Milliseconds (msec) Standard Deviation 9.54
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; Visit 12 (Week 173); n= 24	-1.3 Milliseconds (msec) Standard Deviation 9.04
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; Visit 13 (Week 190); n= 19	-4.9 Milliseconds (msec) Standard Deviation 8.80
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; Visit 14 (Week 208); n= 10	-6.1 Milliseconds (msec) Standard Deviation 6.34
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; Visit 15 (Week 225); n= 5	-2.9 Milliseconds (msec) Standard Deviation 3.44
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; Visit 16 (Week 242); n= 4	-5.9 Milliseconds (msec) Standard Deviation 9.58
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; Visit 17 (Week 260); n= 4	-7.8 Milliseconds (msec) Standard Deviation 5.19
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; Visit 18 (Week 277); n= 2	-4.5 Milliseconds (msec) Standard Deviation 2.12
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; withdrawal visit; n= 82	-2.5 Milliseconds (msec) Standard Deviation 9.49
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QRS duration; follow up visit; n= 59	0.0 Milliseconds (msec) Standard Deviation 11.90
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval;Visit 1 (Screening); n= 85	10.1 Milliseconds (msec) Standard Deviation 26.19
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval; Visit 2 (Week 13); n= 88	4.9 Milliseconds (msec) Standard Deviation 23.43
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval; Visit 3 (Week 26); n= 78	7.9 Milliseconds (msec) Standard Deviation 23.44
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval; Visit 6 (Week 69); n= 61	7.4 Milliseconds (msec) Standard Deviation 26.39
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval; Visit 7 (Week 86); n= 53	-1.6 Milliseconds (msec) Standard Deviation 23.81
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval; Visit 8 (Week 104); n= 41	6.0 Milliseconds (msec) Standard Deviation 26.77
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval; Visit 9 (Week 121); n= 37	-0.5 Milliseconds (msec) Standard Deviation 24.52
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval; Visit 10 (Week 138);n= 36	-8.7 Milliseconds (msec) Standard Deviation 33.60
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval; Visit 11 (Week 156);n= 29	-4.9 Milliseconds (msec) Standard Deviation 33.01
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval; Visit 12 (Week 173);n= 23	4.7 Milliseconds (msec) Standard Deviation 25.06
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval; Visit 13 (Week 190);n= 19	-1.9 Milliseconds (msec) Standard Deviation 26.01
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval; Visit 14 (Week 208);n= 10	-17.0 Milliseconds (msec) Standard Deviation 27.93
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval; Visit 15 (Week 225);n= 5	-1.5 Milliseconds (msec) Standard Deviation 5.68
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval; Visit 16 (Week 242);n= 4	3.1 Milliseconds (msec) Standard Deviation 26.90
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval; Visit 17 (Week 260);n= 4	17.5 Milliseconds (msec) Standard Deviation 36.08
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval Uncorrected QT interval; follow up visit; n= 56	2.7 Milliseconds (msec) Standard Deviation 28.41
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; Visit 1 (Screening); n= 85	5.0 Milliseconds (msec) Standard Deviation 17.35
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; Visit 2 (Week 13); n= 88	3.2 Milliseconds (msec) Standard Deviation 18.52
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; Visit 3 (Week 26); n= 78	4.0 Milliseconds (msec) Standard Deviation 16.48
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; Visit 4 (Week 39); n= 69	6.0 Milliseconds (msec) Standard Deviation 17.27
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; Visit 5 (Week 52); n= 65	5.8 Milliseconds (msec) Standard Deviation 17.14
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; Visit 6 (Week 69); n= 61	6.8 Milliseconds (msec) Standard Deviation 15.01
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; Visit 7 (Week 86); n= 53	4.3 Milliseconds (msec) Standard Deviation 15.71
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; Visit 8 (Week 104); n= 41	2.5 Milliseconds (msec) Standard Deviation 20.70
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; Visit 9 (Week 121); n= 37	4.9 Milliseconds (msec) Standard Deviation 16.01
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; Visit 10 (Week 138); n= 36	-2.8 Milliseconds (msec) Standard Deviation 16.46
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; Visit 11 (Week 156); n= 29	-0.3 Milliseconds (msec) Standard Deviation 19.63
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; Visit 12 (Week 173); n= 23	4.2 Milliseconds (msec) Standard Deviation 24.12
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; Visit 13 (Week 190); n= 19	3.9 Milliseconds (msec) Standard Deviation 20.16
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; Visit 14 (Week 208); n= 10	-1.6 Milliseconds (msec) Standard Deviation 14.91
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; Visit 15 (Week 225); n= 5	-1.9 Milliseconds (msec) Standard Deviation 18.26
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; Visit 16 (Week 242); n= 4	-9.8 Milliseconds (msec) Standard Deviation 15.09
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; Visit 17 (Week 260); n= 4	-2.0 Milliseconds (msec) Standard Deviation 27.12
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; Visit 18 (Week 277); n= 2	4.5 Milliseconds (msec) Standard Deviation 17.68
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; withdrawal visit; n= 80	-0.7 Milliseconds (msec) Standard Deviation 20.78
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcB; follow up visit; n= 56	-1.0 Milliseconds (msec) Standard Deviation 17.84
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; Visit 1 (Screening); n= 85	6.8 Milliseconds (msec) Standard Deviation 16.11
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; Visit 2 (Week 13); n= 88	3.7 Milliseconds (msec) Standard Deviation 15.74
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; Visit 3 (Week 26); n= 78	5.4 Milliseconds (msec) Standard Deviation 15.01
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; Visit 4 (Week 39); n= 69	7.1 Milliseconds (msec) Standard Deviation 16.58
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; Visit 5 (Week 52); n= 65	6.1 Milliseconds (msec) Standard Deviation 14.92
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; Visit 6 (Week 69); n= 61	7.1 Milliseconds (msec) Standard Deviation 14.47
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; Visit 7 (Week 86); n= 53	2.3 Milliseconds (msec) Standard Deviation 16.04
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; Visit 8 (Week 104); n= 41	3.7 Milliseconds (msec) Standard Deviation 19.31
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; Visit 9 (Week 121); n= 37	3.0 Milliseconds (msec) Standard Deviation 12.90
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; Visit 10 (Week 138); n= 36	-4.8 Milliseconds (msec) Standard Deviation 18.22
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; Visit 11 (Week 156); n= 29	-1.8 Milliseconds (msec) Standard Deviation 21.86
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; Visit 12 (Week 173); n= 23	4.6 Milliseconds (msec) Standard Deviation 17.51
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; Visit 13 (Week 190); n= 19	1.9 Milliseconds (msec) Standard Deviation 17.47
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; Visit 14 (Week 208); n= 10	-7.0 Milliseconds (msec) Standard Deviation 14.99
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; Visit 15 (Week 225); n= 5	-1.6 Milliseconds (msec) Standard Deviation 10.53
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; Visit 16 (Week 242); n= 4	-5.4 Milliseconds (msec) Standard Deviation 8.96
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; Visit 17 (Week 260); n= 4	5.3 Milliseconds (msec) Standard Deviation 29.75
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; Visit 18 (Week 277); n= 2	2.0 Milliseconds (msec) Standard Deviation 24.04
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; withdrawal visit; n= 80	1.3 Milliseconds (msec) Standard Deviation 18.24
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval QTcF; follow up visit; n= 56	0.3 Milliseconds (msec) Standard Deviation 15.49
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; visit 1 (Screening); n= 89	27.9 Milliseconds (msec) Standard Deviation 120.57
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; visit 2 (Week 13); n= 90	12.2 Milliseconds (msec) Standard Deviation 115.82
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; visit 3 (Week 26); n= 80	20.5 Milliseconds (msec) Standard Deviation 110.48
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; visit 4 (Week 39); n= 71	22.4 Milliseconds (msec) Standard Deviation 107.77
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; visit 5 (Week 52); n= 67	10.3 Milliseconds (msec) Standard Deviation 128.05
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; visit 6 (Week 69); n= 63	6.2 Milliseconds (msec) Standard Deviation 127.01
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; visit 7 (Week 86); n= 56	-18.5 Milliseconds (msec) Standard Deviation 102.45
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; visit 8 (Week 104); n= 42	23.7 Milliseconds (msec) Standard Deviation 121.17
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; visit 9 (Week 121); n= 38	-17.5 Milliseconds (msec) Standard Deviation 134.18
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; visit 11 (Week 156); n= 30	-16.0 Milliseconds (msec) Standard Deviation 120.50
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; visit 12 (Week 173); n= 24	12.9 Milliseconds (msec) Standard Deviation 163.66
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; visit 13 (Week 190); n= 19	-19.5 Milliseconds (msec) Standard Deviation 138.03
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; visit 14 (Week 208); n= 10	-70.7 Milliseconds (msec) Standard Deviation 130.51
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; visit 16 (Week 242); n= 4	56.6 Milliseconds (msec) Standard Deviation 165.75
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; visit 17 (Week 260); n= 4	83.5 Milliseconds (msec) Standard Deviation 91.72
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; visit 18 (Week 277); n= 2	-30.0 Milliseconds (msec) Standard Deviation 86.27
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; withdrawal visit; n= 83	29.1 Milliseconds (msec) Standard Deviation 152.19
Change From Baseline in ECG Parameter Including PR Interval, QRS Duration, Uncorrected QT Interval, Corrected QT by Bazett's Formula (QTcB), Corrected QT by Fridericia's Formula (QTcF) and RR Interval RR interval; follow up visit; n= 59	15.9 Milliseconds (msec) Standard Deviation 150.13

PRIMARY outcome

Timeframe: Up to 5.8 years

Population: Safety Population

Number of participants with chemistry parameters of PCC at 'any visit post-Baseline' are presented. Chemistry parameters for which PCC values were identified were alanine aminotransferase (ALT) (if value \>=3 \* upper limit of normal \[ULN\]), alkaline phosphatase (alk.phosphatase) (if value \>=3\*ULN), aspartate aminotransferase (AST) (if value \>=3\*ULN), calcium (if value \<=1.8962 or \>=2.8692), carbon-di-oxide (CO2) (if value \<=18 or \>=36), chloride (if value \<=92 or \>=112), creatine kinase (if value \>=3\*ULN), direct bilirubin (if value \>=1.5\*ULN), glucose (if value \<=2.7755 or \>=11.102), lactate dehydrogenase (LD) (if value \>=3\*ULN), magnesium (if value \<0.36 or \>2.50), potassium (if value \<=3.0 or \>=6.0), sodium (if value \<=127 or \>=153), total bilirubin (if value \>=1.5\*ULN), total protein (if value \<45 or \>100), blood urea nitrogen (BUN) (if value \>=14.28). Only those participants with data available at specific time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants With Clinical Chemistry Parameters of PCC Calcium; low; n= 98	0 Participants
Number of Participants With Clinical Chemistry Parameters of PCC CO2 content/bicarbonate; high; n= 98	0 Participants
Number of Participants With Clinical Chemistry Parameters of PCC ALT; high; n= 98	2 Participants
Number of Participants With Clinical Chemistry Parameters of PCC Alk.phosphatase; high; n= 98	0 Participants
Number of Participants With Clinical Chemistry Parameters of PCC AST; high; n= 98	1 Participants
Number of Participants With Clinical Chemistry Parameters of PCC Calcium; high; n= 98	0 Participants
Number of Participants With Clinical Chemistry Parameters of PCC CO2 content/bicrbonate; low; n= 98	10 Participants
Number of Participants With Clinical Chemistry Parameters of PCC Chloride; high; n= 98	6 Participants
Number of Participants With Clinical Chemistry Parameters of PCC Chloride; low; n= 98	2 Participants
Number of Participants With Clinical Chemistry Parameters of PCC Creatine kinase; high; n= 98	6 Participants
Number of Participants With Clinical Chemistry Parameters of PCC Creatinine; high; n= 98	0 Participants
Number of Participants With Clinical Chemistry Parameters of PCC Direct bilirubin; high; n= 98	0 Participants
Number of Participants With Clinical Chemistry Parameters of PCC Glucose; high; n= 98	3 Participants
Number of Participants With Clinical Chemistry Parameters of PCC Glucose; low; n= 98	1 Participants
Number of Participants With Clinical Chemistry Parameters of PCC LD ; high; n= 98	1 Participants
Number of Participants With Clinical Chemistry Parameters of PCC Magnesium; high; n= 98	0 Participants
Number of Participants With Clinical Chemistry Parameters of PCC Magnesium; low; n= 98	0 Participants
Number of Participants With Clinical Chemistry Parameters of PCC Potassium; high; n= 98	1 Participants
Number of Participants With Clinical Chemistry Parameters of PCC Potassium; low; n= 98	0 Participants
Number of Participants With Clinical Chemistry Parameters of PCC Sodium; high; n= 91	0 Participants
Number of Participants With Clinical Chemistry Parameters of PCC Sodium; low; n= 91	2 Participants
Number of Participants With Clinical Chemistry Parameters of PCC Total bilirubin; high; n= 98	1 Participants
Number of Participants With Clinical Chemistry Parameters of PCC Total protein; high; n= 98	0 Participants
Number of Participants With Clinical Chemistry Parameters of PCC Total protein; low; n= 98	0 Participants
Number of Participants With Clinical Chemistry Parameters of PCC BUN; high; n= 91	0 Participants

PRIMARY outcome

Timeframe: Up to 5.8 years

Population: Safety Population

Blood samples were collected from participants to evaluate hematology parameters. Number of participants with clinical hematology parameters of PCC at 'any visit post-Baseline' are presented. Hematology parameters for which PCC values were identified were eosinophils (if value is \>0.8), hematocrit (if value is \<=0.32 for males and \<=0.28 for females), platelet count (if value is \<=100 or \>=550), total neutrophils (if value is \<=1.8), white blood cells (WBC) (if value is \<=2.8 or \>=16). Only those participants with data available at specific time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants With Hematology Parameters of PCC Eosinophils; high; n= 98	7 Participants
Number of Participants With Hematology Parameters of PCC Hematocrit; low; n= 98	4 Participants
Number of Participants With Hematology Parameters of PCC Hemoglobin; low; n= 98	3 Participants
Number of Participants With Hematology Parameters of PCC Platelet count; high; n= 98	1 Participants
Number of Participants With Hematology Parameters of PCC Platelet count; low; n= 98	4 Participants
Number of Participants With Hematology Parameters of PCC Total neutrophils; low; n= 98	20 Participants
Number of Participants With Hematology Parameters of PCC WBC; high; n= 91	2 Participants
Number of Participants With Hematology Parameters of PCC WBC; low; n= 91	3 Participants

PRIMARY outcome

Timeframe: Up to 5.8 years

Population: Safety Population

Urine samples were collected from participants at specific time points. Number of participants with urinalysis parameters of PCC at 'any visit post-Baseline' are presented. Urinalysis parameters for which PCC values were identified were albumin/creatinine ratio (if value is \>11.3), red blood cells (RBC) (if value is 3-5 or higher), WBC (if value is 5-10 or higher for male and 10-15 or higher for females), specific gravity (if value is \<1.001 or \>1.035) and potential of hydrogen (pH) (if value is \<4.6 or \>8.0). Only those participants with data available at specific time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants With Urinalysis Parameters of PCC pH; low; n= 98	0 Participants
Number of Participants With Urinalysis Parameters of PCC pH; high; n= 98	1 Participants
Number of Participants With Urinalysis Parameters of PCC Albumin/creatinine ratio; high; n= 96	4 Participants
Number of Participants With Urinalysis Parameters of PCC RBC; high; n= 98	54 Participants
Number of Participants With Urinalysis Parameters of PCC WBC; high; n= 91	59 Participants
Number of Participants With Urinalysis Parameters of PCC Specific gravity; high; n= 91	4 Participants
Number of Participants With Urinalysis Parameters of PCC Specific gravity; low; n= 91	0 Participants

PRIMARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including albumin and total protein. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Change From Baseline in Albumin and Total Protein Total protein; visit 2 (Week 13); n= 87	-1.0 Gram per liter (G/L) Standard Deviation 4.59
Change From Baseline in Albumin and Total Protein Total protein; visit 3 (Week 26); n= 75	-1.5 Gram per liter (G/L) Standard Deviation 5.15
Change From Baseline in Albumin and Total Protein Total protein; visit 17 (Week 260); n= 4	-2.3 Gram per liter (G/L) Standard Deviation 3.30
Change From Baseline in Albumin and Total Protein Total protein; visit 18 (Week 277); n= 2	-4.5 Gram per liter (G/L) Standard Deviation 2.12
Change From Baseline in Albumin and Total Protein Total protein; follow up visit; n= 60	-2.1 Gram per liter (G/L) Standard Deviation 6.12
Change From Baseline in Albumin and Total Protein Albumin; visit 5 (Week 52); n= 65	-1.5 Gram per liter (G/L) Standard Deviation 3.25
Change From Baseline in Albumin and Total Protein Albumin; visit 6 (Week 69); n= 62	-1.1 Gram per liter (G/L) Standard Deviation 3.11
Change From Baseline in Albumin and Total Protein Albumin; visit 7 (Week 86); n= 54	-1.0 Gram per liter (G/L) Standard Deviation 2.70
Change From Baseline in Albumin and Total Protein Albumin; visit 8 (Week 104); n= 42	-1.6 Gram per liter (G/L) Standard Deviation 3.05
Change From Baseline in Albumin and Total Protein Albumin; visit 9 (Week 121); n= 39	-2.1 Gram per liter (G/L) Standard Deviation 2.88
Change From Baseline in Albumin and Total Protein Albumin; visit 10 (Week 138); n= 36	-2.2 Gram per liter (G/L) Standard Deviation 3.16
Change From Baseline in Albumin and Total Protein Albumin; visit 1 (Screening); n= 83	-1.6 Gram per liter (G/L) Standard Deviation 2.72
Change From Baseline in Albumin and Total Protein Albumin; visit 2 (Week 13); n= 87	-0.9 Gram per liter (G/L) Standard Deviation 2.70
Change From Baseline in Albumin and Total Protein Albumin; visit 3 (Week 26); n= 75	-0.8 Gram per liter (G/L) Standard Deviation 2.83
Change From Baseline in Albumin and Total Protein Albumin; visit 4 (Week 39); n= 70	-0.7 Gram per liter (G/L) Standard Deviation 3.09
Change From Baseline in Albumin and Total Protein Albumin; visit 11 (Week 156); n= 30	-3.0 Gram per liter (G/L) Standard Deviation 3.62
Change From Baseline in Albumin and Total Protein Albumin; visit 12 (Week 173); n= 23	-1.7 Gram per liter (G/L) Standard Deviation 2.82
Change From Baseline in Albumin and Total Protein Albumin; visit 13 (Week 190); n= 19	-2.9 Gram per liter (G/L) Standard Deviation 3.62
Change From Baseline in Albumin and Total Protein Albumin; visit14 (Week 208); n= 10	-3.9 Gram per liter (G/L) Standard Deviation 3.78
Change From Baseline in Albumin and Total Protein Albumin; visit 15 (Week 225); n= 5	-3.4 Gram per liter (G/L) Standard Deviation 1.52
Change From Baseline in Albumin and Total Protein Albumin; visit 16 (Week242); n= 4	-4.3 Gram per liter (G/L) Standard Deviation 1.26
Change From Baseline in Albumin and Total Protein Albumin; visit 17 (Week 260); n= 4	-4.0 Gram per liter (G/L) Standard Deviation 1.15
Change From Baseline in Albumin and Total Protein Albumin; visit 18 (Week 277); n= 2	-4.5 Gram per liter (G/L) Standard Deviation 0.71
Change From Baseline in Albumin and Total Protein Albumin; withdrawal visit; n= 79	-1.8 Gram per liter (G/L) Standard Deviation 3.11
Change From Baseline in Albumin and Total Protein Albumin; follow up visit; n= 60	-2.3 Gram per liter (G/L) Standard Deviation 3.42
Change From Baseline in Albumin and Total Protein Total protein; visit 1 (Screening); n= 83	-2.0 Gram per liter (G/L) Standard Deviation 4.57
Change From Baseline in Albumin and Total Protein Total protein; visit 4 (Week 39); n= 70	-1.8 Gram per liter (G/L) Standard Deviation 4.13
Change From Baseline in Albumin and Total Protein Total protein; visit 5 (Week 52); n= 65	-2.6 Gram per liter (G/L) Standard Deviation 4.74
Change From Baseline in Albumin and Total Protein Total protein; visit 6 (Week 69); n= 62	-1.4 Gram per liter (G/L) Standard Deviation 4.09
Change From Baseline in Albumin and Total Protein Total protein; visit 7 (Week 86); n= 54	-1.0 Gram per liter (G/L) Standard Deviation 4.44
Change From Baseline in Albumin and Total Protein Total protein; visit 8 (Week 104); n= 42	-1.5 Gram per liter (G/L) Standard Deviation 4.65
Change From Baseline in Albumin and Total Protein Total protein; visit 9 (Week 121); n= 39	-2.1 Gram per liter (G/L) Standard Deviation 4.58
Change From Baseline in Albumin and Total Protein Total protein; visit 10 (Week 138); n= 36	-2.7 Gram per liter (G/L) Standard Deviation 4.90
Change From Baseline in Albumin and Total Protein Total protein; visit 11 (Week 156); n= 30	-3.2 Gram per liter (G/L) Standard Deviation 5.40
Change From Baseline in Albumin and Total Protein Total protein; visit 12 (Week 173); n= 23	-1.1 Gram per liter (G/L) Standard Deviation 4.07
Change From Baseline in Albumin and Total Protein Total protein; visit 13 (Week 190); n= 19	-1.9 Gram per liter (G/L) Standard Deviation 5.57
Change From Baseline in Albumin and Total Protein Total protein; visit 14 (Week 208); n= 10	-3.1 Gram per liter (G/L) Standard Deviation 3.41
Change From Baseline in Albumin and Total Protein Total protein; visit 15 (Week 225); n= 5	-3.4 Gram per liter (G/L) Standard Deviation 2.51
Change From Baseline in Albumin and Total Protein Total protein; visit 16 (Week 242); n= 4	-3.8 Gram per liter (G/L) Standard Deviation 4.99
Change From Baseline in Albumin and Total Protein Total protein; withdrawal visit; n= 79	-2.5 Gram per liter (G/L) Standard Deviation 5.27

PRIMARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including alk. phosphatase, ALT, AST, creatine kinase and LD. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; visit 1 (Screening); n= 82	-2.7 International unit per liter (IU/L) Standard Deviation 15.51
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; visit 2 (Week 13); n= 86	1.1 International unit per liter (IU/L) Standard Deviation 14.02
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; visit 3 (Week 26); n= 75	3.5 International unit per liter (IU/L) Standard Deviation 15.80
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; visit 4 (week 39); n= 70	3.9 International unit per liter (IU/L) Standard Deviation 15.46
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; visit 5 (Week 52); n= 65	1.0 International unit per liter (IU/L) Standard Deviation 15.36
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; visit 6 (Week 69); n= 62	4.1 International unit per liter (IU/L) Standard Deviation 14.22
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; visit 7 (Week 86); n= 54	4.0 International unit per liter (IU/L) Standard Deviation 16.01
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; visit 8 (Week 104); n= 42	-0.3 International unit per liter (IU/L) Standard Deviation 18.27
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; visit 9 (Week 121); n= 39	2.4 International unit per liter (IU/L) Standard Deviation 16.33
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; visit 10 (Week 138); n= 36	2.2 International unit per liter (IU/L) Standard Deviation 21.08
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; visit 11 (Week 156); n= 30	-1.4 International unit per liter (IU/L) Standard Deviation 18.49
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; visit 12 (Week 173); n= 23	5.5 International unit per liter (IU/L) Standard Deviation 20.76
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; visit 13 (Week 190); n= 19	6.3 International unit per liter (IU/L) Standard Deviation 23.61
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; visit 14 (Week 208); n= 10	6.1 International unit per liter (IU/L) Standard Deviation 19.84
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; visit 15 (Week 225); n= 5	5.8 International unit per liter (IU/L) Standard Deviation 16.95
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; visit 16 (Week 242); n= 4	9.5 International unit per liter (IU/L) Standard Deviation 15.55
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; visit 17 (Week 260); n= 4	7.3 International unit per liter (IU/L) Standard Deviation 7.14
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; visit 18 (Week 277); n= 2	-4.5 International unit per liter (IU/L) Standard Deviation 10.61
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; withdrawal visit; n= 78	2.5 International unit per liter (IU/L) Standard Deviation 19.86
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Alk. phosphatase; follow up visit; n= 60	-0.3 International unit per liter (IU/L) Standard Deviation 19.59
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; visit 1 (Screening); n= 83	1.3 International unit per liter (IU/L) Standard Deviation 10.90
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; visit 2 (Week 13); n= 87	3.4 International unit per liter (IU/L) Standard Deviation 23.41
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; visit 3 (Week 26); n= 76	1.0 International unit per liter (IU/L) Standard Deviation 23.35
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; visit 4 (Week 39); n= 70	-0.5 International unit per liter (IU/L) Standard Deviation 10.22
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; visit 5 (Week 52); n= 65	-0.4 International unit per liter (IU/L) Standard Deviation 8.21
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; visit 6 (Week 69); n= 62	-0.0 International unit per liter (IU/L) Standard Deviation 11.51
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; visit 7 (Week 86); n= 54	-1.9 International unit per liter (IU/L) Standard Deviation 10.02
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; visit 8 (Week 104); n= 42	-1.5 International unit per liter (IU/L) Standard Deviation 8.58
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; visit 9 (Week 121); n= 39	0.4 International unit per liter (IU/L) Standard Deviation 8.80
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; visit 10 (Week 138); n= 36	3.4 International unit per liter (IU/L) Standard Deviation 21.74
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; visit 11 (Week 156); n= 29	-1.1 International unit per liter (IU/L) Standard Deviation 8.21
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; visit 12 (Week 173); n= 23	-1.3 International unit per liter (IU/L) Standard Deviation 7.97
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; visit 13 (Week 190); n= 19	0.0 International unit per liter (IU/L) Standard Deviation 8.10
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; visit 14 (Week 208); n= 10	0.7 International unit per liter (IU/L) Standard Deviation 7.32
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; visit 15 (Week 225); n= 5	-2.0 International unit per liter (IU/L) Standard Deviation 4.47
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; visit 16 (Week 242); n= 4	-0.5 International unit per liter (IU/L) Standard Deviation 8.54
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; visit 17 (Week 260); n= 4	0.0 International unit per liter (IU/L) Standard Deviation 6.98
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; visit 18 (Week 277); n= 2	3.5 International unit per liter (IU/L) Standard Deviation 3.54
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; withdrawal visit; n= 79	0.7 International unit per liter (IU/L) Standard Deviation 10.17
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels ALT; follow up visit; n= 60	0.1 International unit per liter (IU/L) Standard Deviation 8.43
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; visit 1 (Screening); n= 82	1.7 International unit per liter (IU/L) Standard Deviation 7.97
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; visit 2 (Week 13); n= 86	5.1 International unit per liter (IU/L) Standard Deviation 31.13
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; visit 3 (Week 26); n= 75	2.9 International unit per liter (IU/L) Standard Deviation 23.95
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; visit 4 (Week 39); n= 70	1.3 International unit per liter (IU/L) Standard Deviation 8.23
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; visit 5 (Week 52); n= 65	2.5 International unit per liter (IU/L) Standard Deviation 6.01
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; visit 6 (Week 69); n= 62	1.5 International unit per liter (IU/L) Standard Deviation 7.55
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; visit 7 (Week 86); n= 54	1.7 International unit per liter (IU/L) Standard Deviation 8.20
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; visit 8 (Week 104); n= 42	1.5 International unit per liter (IU/L) Standard Deviation 7.94
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; visit 9 (Week 121); n= 39	2.6 International unit per liter (IU/L) Standard Deviation 7.99
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; visit 10 (Week 138); n= 36	6.4 International unit per liter (IU/L) Standard Deviation 17.36
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; visit 11 (Week 156); n= 30	1.4 International unit per liter (IU/L) Standard Deviation 7.38
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; visit 12 (Week 173); n= 23	2.7 International unit per liter (IU/L) Standard Deviation 4.71
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; visit 13 (Week 190); n= 19	3.3 International unit per liter (IU/L) Standard Deviation 5.21
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; visit 14 (Week 208); n= 10	3.5 International unit per liter (IU/L) Standard Deviation 6.42
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; visit 15 (Week 225); n= 5	4.2 International unit per liter (IU/L) Standard Deviation 2.95
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; visit 16 (Week 242); n= 4	4.3 International unit per liter (IU/L) Standard Deviation 4.72
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; visit 17 (Week 260); n= 4	5.5 International unit per liter (IU/L) Standard Deviation 3.11
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; visit 18 (Week 277); n= 2	10.0 International unit per liter (IU/L) Standard Deviation 9.90
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; withdrawal visit; n= 78	1.8 International unit per liter (IU/L) Standard Deviation 7.87
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels AST; follow up visit; n= 60	1.2 International unit per liter (IU/L) Standard Deviation 6.99
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; Visit 1 (Screening); n= 82	16.4 International unit per liter (IU/L) Standard Deviation 132.76
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; Visit 2 (Week 13); n= 86	11.3 International unit per liter (IU/L) Standard Deviation 78.18
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; Visit 3 (Week 26); n= 74	11.7 International unit per liter (IU/L) Standard Deviation 59.78
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; Visit 4 (Week 39); n= 70	49.4 International unit per liter (IU/L) Standard Deviation 397.67
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; Visit 5 (Week 52); n= 65	31.3 International unit per liter (IU/L) Standard Deviation 136.41
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; Visit 6 (Week 69); n= 62	11.1 International unit per liter (IU/L) Standard Deviation 55.13
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; Visit 7 (Week 86); n= 54	23.6 International unit per liter (IU/L) Standard Deviation 92.64
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; Visit 8 (Week 104); n= 42	33.2 International unit per liter (IU/L) Standard Deviation 110.99
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; Visit 9 (Week 121); n= 39	22.5 International unit per liter (IU/L) Standard Deviation 77.04
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; Visit 10 (Week 138); n= 36	24.8 International unit per liter (IU/L) Standard Deviation 83.80
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; Visit 11 (Week 156); n= 30	31.9 International unit per liter (IU/L) Standard Deviation 86.68
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; Visit 12 (Week 173); n= 23	29.1 International unit per liter (IU/L) Standard Deviation 97.10
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; Visit 13 (Week 190); n= 19	50.2 International unit per liter (IU/L) Standard Deviation 125.12
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; Visit 14 (Week 208); n= 10	-7.9 International unit per liter (IU/L) Standard Deviation 101.39
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; Visit 15 (Week 225); n= 5	42.6 International unit per liter (IU/L) Standard Deviation 99.09
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; Visit 16 (Week 242); n= 4	90.3 International unit per liter (IU/L) Standard Deviation 127.49
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; Visit 17 (Week 260); n= 4	78.8 International unit per liter (IU/L) Standard Deviation 110.78
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; Visit 18 (Week 277); n= 2	-27.5 International unit per liter (IU/L) Standard Deviation 102.53
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; withdrawal visit; n= 78	28.7 International unit per liter (IU/L) Standard Deviation 139.96
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels Creatine kinase; follow up visit; n= 60	33.9 International unit per liter (IU/L) Standard Deviation 128.19
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; visit 1(Screening); n= 82	3.7 International unit per liter (IU/L) Standard Deviation 23.16
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; visit 2 (Week 13); n= 86	4.3 International unit per liter (IU/L) Standard Deviation 32.66
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; visit 3 (Week 26); n= 74	0.0 International unit per liter (IU/L) Standard Deviation 27.88
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; visit 4 (Week 39); n= 69	0.4 International unit per liter (IU/L) Standard Deviation 28.51
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; visit 5 (Week 52); n= 64	2.1 International unit per liter (IU/L) Standard Deviation 28.01
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; visit 6 (Week 69); n= 61	-0.1 International unit per liter (IU/L) Standard Deviation 25.98
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; visit 7 (Week 86); n= 54	9.2 International unit per liter (IU/L) Standard Deviation 30.42
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; visit 8 (Week 104); n= 42	4.7 International unit per liter (IU/L) Standard Deviation 29.37
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; visit 9 (Week 121); n= 39	18.8 International unit per liter (IU/L) Standard Deviation 53.56
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; visit 10 (Week 138); n= 36	33.0 International unit per liter (IU/L) Standard Deviation 131.87
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; visit 11 (Week 156); n= 30	13.7 International unit per liter (IU/L) Standard Deviation 33.18
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; visit 12 (Week 173); n= 23	4.1 International unit per liter (IU/L) Standard Deviation 31.91
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; visit 13 (Week 190); n= 19	30.0 International unit per liter (IU/L) Standard Deviation 58.17
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; visit 14 (Week 208); n= 10	25.8 International unit per liter (IU/L) Standard Deviation 42.76
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; visit 15 (Week 225); n= 5	34.6 International unit per liter (IU/L) Standard Deviation 25.93
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; visit 16 (Week 242); n= 4	25.8 International unit per liter (IU/L) Standard Deviation 15.97
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; visit 17 (Week 260); n= 4	20.8 International unit per liter (IU/L) Standard Deviation 25.86
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; visit 18 (Week 277); n= 2	52.0 International unit per liter (IU/L) Standard Deviation 60.81
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; withdrawal visit; n= 78	7.8 International unit per liter (IU/L) Standard Deviation 31.17
Change From Baseline in Alk. Phosphatase, ALT, AST, Creatine Kinase and LD Levels LD; follow up visit; n= 60	5.6 International unit per liter (IU/L) Standard Deviation 36.94

PRIMARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including direct bilirubin, total bilirubin and creatinine. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; visit 1 (Screening); n= 83	0.1 Micromole per liter (µmol/L) Standard Deviation 0.95
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; visit 14 (Week 208); n= 10	0.3 Micromole per liter (µmol/L) Standard Deviation 3.27
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; visit 12 (Week 173); n= 23	-0.93 Micromole per liter (µmol/L) Standard Deviation 10.097
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; visit 2 (Week 13); n= 87	-0.1 Micromole per liter (µmol/L) Standard Deviation 0.96
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; visit 3 (Week 26); n= 75	-0.2 Micromole per liter (µmol/L) Standard Deviation 0.94
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; visit 4 (Week 39); n= 69	-0.1 Micromole per liter (µmol/L) Standard Deviation 0.91
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; visit 5 (Week 52); n= 65	0.0 Micromole per liter (µmol/L) Standard Deviation 0.95
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; visit 6 (Week 69); n= 62	-0.0 Micromole per liter (µmol/L) Standard Deviation 0.97
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; visit 7 (Week 86); n= 54	-0.2 Micromole per liter (µmol/L) Standard Deviation 1.17
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; visit 8 (Week 104); n= 42	-0.0 Micromole per liter (µmol/L) Standard Deviation 0.91
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; visit 9 (Week 121); n= 39	-0.2 Micromole per liter (µmol/L) Standard Deviation 0.87
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; visit 10 (Week 138); n= 36	-0.1 Micromole per liter (µmol/L) Standard Deviation 1.27
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; visit 11 (Week 156); n= 30	0.0 Micromole per liter (µmol/L) Standard Deviation 0.72
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; visit 12 (Week 173); n= 23	-0.1 Micromole per liter (µmol/L) Standard Deviation 0.73
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; visit 13 (Week 190); n= 19	0.1 Micromole per liter (µmol/L) Standard Deviation 0.91
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; visit 14 (Week 208); n= 10	0.0 Micromole per liter (µmol/L) Standard Deviation 0.67
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; visit 15 (Week 225); n= 5	-0.2 Micromole per liter (µmol/L) Standard Deviation 0.84
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; visit 16 (Week 242); n= 4	-0.5 Micromole per liter (µmol/L) Standard Deviation 1.00
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; visit 17 (Week 260); n= 4	-0.5 Micromole per liter (µmol/L) Standard Deviation 1.29
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; visit 18 (Week 277); n= 2	0.5 Micromole per liter (µmol/L) Standard Deviation 2.12
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; withdrawal visit; n= 79	0.0 Micromole per liter (µmol/L) Standard Deviation 1.15
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Direct bilirubin; follow up visit; n= 60	-0.2 Micromole per liter (µmol/L) Standard Deviation 0.98
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; visit 1 (Screening); n= 83	2.5 Micromole per liter (µmol/L) Standard Deviation 3.78
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; visit 2 (Week 13); n= 87	1.8 Micromole per liter (µmol/L) Standard Deviation 4.28
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; visit 3 (Week 26); n= 76	1.8 Micromole per liter (µmol/L) Standard Deviation 3.78
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; visit 4 (Week 39); n= 70	2.1 Micromole per liter (µmol/L) Standard Deviation 4.46
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; visit 5 (Week 52); n= 65	2.6 Micromole per liter (µmol/L) Standard Deviation 4.26
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; visit 6 (Week 69); n= 62	1.8 Micromole per liter (µmol/L) Standard Deviation 4.21
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; visit 7 (Week 86); n= 54	1.4 Micromole per liter (µmol/L) Standard Deviation 4.41
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; visit 8 (Week 104); n= 42	1.8 Micromole per liter (µmol/L) Standard Deviation 3.28
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; visit 9 (Week 121); n= 39	1.1 Micromole per liter (µmol/L) Standard Deviation 3.59
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; visit 10 (Week 138); n= 36	1.6 Micromole per liter (µmol/L) Standard Deviation 6.50
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; visit 11 (Week 156); n= 30	0.5 Micromole per liter (µmol/L) Standard Deviation 2.99
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; visit 12 (Week 173); n= 23	0.6 Micromole per liter (µmol/L) Standard Deviation 2.81
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; visit 13 (Week 190); n= 19	0.2 Micromole per liter (µmol/L) Standard Deviation 4.26
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; visit 15 (Week 225); n= 5	0.8 Micromole per liter (µmol/L) Standard Deviation 2.17
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; visit 16 (Week 242); n= 4	1.3 Micromole per liter (µmol/L) Standard Deviation 1.89
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; visit 17 (Week 260); n= 4	-0.3 Micromole per liter (µmol/L) Standard Deviation 2.63
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; visit 18 (Week 277); n= 2	1.5 Micromole per liter (µmol/L) Standard Deviation 0.71
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; withdrawal visit; n= 79	1.2 Micromole per liter (µmol/L) Standard Deviation 3.75
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Total bilirubin; follow up visit; n= 60	-0.8 Micromole per liter (µmol/L) Standard Deviation 3.97
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; visit 1 (Screening); n= 82	3.68 Micromole per liter (µmol/L) Standard Deviation 9.813
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; visit 2 (Week 13); n= 86	0.42 Micromole per liter (µmol/L) Standard Deviation 8.033
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; visit 3 (Week 26); n= 74	0.65 Micromole per liter (µmol/L) Standard Deviation 8.879
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; visit 4 (Week 39); n= 70	1.82 Micromole per liter (µmol/L) Standard Deviation 9.716
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; visit 5 (Week 52); n= 65	1.40 Micromole per liter (µmol/L) Standard Deviation 9.394
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; visit 6 (Week 69); n= 62	1.25 Micromole per liter (µmol/L) Standard Deviation 8.980
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; visit 7 (Week 86); n= 54	0.55 Micromole per liter (µmol/L) Standard Deviation 9.053
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; visit 8 (Week 104); n= 42	4.78 Micromole per liter (µmol/L) Standard Deviation 8.921
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; visit 9 (Week 121); n= 39	3.67 Micromole per liter (µmol/L) Standard Deviation 9.581
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; visit 10 (Week 138); n= 36	2.10 Micromole per liter (µmol/L) Standard Deviation 11.317
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; visit 11 (Week 156); n= 30	5.33 Micromole per liter (µmol/L) Standard Deviation 11.211
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; visit 13 (Week 190); n= 19	1.67 Micromole per liter (µmol/L) Standard Deviation 11.314
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; visit 14 (Week 208); n= 10	-1.74 Micromole per liter (µmol/L) Standard Deviation 13.636
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; visit 15 (Week 225); n= 5	2.08 Micromole per liter (µmol/L) Standard Deviation 6.680
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; visit 16 (Week 242); n= 4	5.80 Micromole per liter (µmol/L) Standard Deviation 8.844
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; visit 17 (Week 260); n= 4	9.23 Micromole per liter (µmol/L) Standard Deviation 14.076
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; visit 18 (Week 277); n= 2	3.45 Micromole per liter (µmol/L) Standard Deviation 8.697
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; withdrawal visit; n= 78	0.88 Micromole per liter (µmol/L) Standard Deviation 8.920
Change From Baseline in Direct Bilirubin, Total Bilirubin and Creatinine Creatinine; follow up visit; n= 60	0.16 Micromole per liter (µmol/L) Standard Deviation 9.873

PRIMARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including BUN/creatinine ratio. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Change From Baseline in BUN/Creatinine Ratio Visit 15 (Week 225); n= 5	-8.8 Ratio of BUN to creatinine Standard Deviation 20.22
Change From Baseline in BUN/Creatinine Ratio Visit 1 (Screening); n= 82	0.3 Ratio of BUN to creatinine Standard Deviation 20.71
Change From Baseline in BUN/Creatinine Ratio Visit 2 (Week 13); n= 86	3.8 Ratio of BUN to creatinine Standard Deviation 23.49
Change From Baseline in BUN/Creatinine Ratio Visit 3 (Week 26); n= 74	2.7 Ratio of BUN to creatinine Standard Deviation 20.38
Change From Baseline in BUN/Creatinine Ratio Visit 4 (Week 39); n= 70	1.0 Ratio of BUN to creatinine Standard Deviation 23.43
Change From Baseline in BUN/Creatinine Ratio Visit 5 (Week 52); n= 65	1.9 Ratio of BUN to creatinine Standard Deviation 27.30
Change From Baseline in BUN/Creatinine Ratio Visit 6 (Week 69); n= 62	-0.0 Ratio of BUN to creatinine Standard Deviation 22.69
Change From Baseline in BUN/Creatinine Ratio Visit 7 (Week 86); n= 54	2.5 Ratio of BUN to creatinine Standard Deviation 24.05
Change From Baseline in BUN/Creatinine Ratio Visit 8 (Week 104); n= 42	-2.5 Ratio of BUN to creatinine Standard Deviation 24.45
Change From Baseline in BUN/Creatinine Ratio Visit 9 (Week 121); n= 39	0.6 Ratio of BUN to creatinine Standard Deviation 24.67
Change From Baseline in BUN/Creatinine Ratio Visit 10 (Week 138); n= 36	0.2 Ratio of BUN to creatinine Standard Deviation 27.01
Change From Baseline in BUN/Creatinine Ratio Visit 11 (Week 156); n= 30	-6.2 Ratio of BUN to creatinine Standard Deviation 24.68
Change From Baseline in BUN/Creatinine Ratio Visit 12 (Week 173); n= 23	-5.7 Ratio of BUN to creatinine Standard Deviation 22.82
Change From Baseline in BUN/Creatinine Ratio Visit 13 (Week 190); n= 19	1.1 Ratio of BUN to creatinine Standard Deviation 22.19
Change From Baseline in BUN/Creatinine Ratio Visit 14 (Week 208); n= 10	-0.8 Ratio of BUN to creatinine Standard Deviation 23.37
Change From Baseline in BUN/Creatinine Ratio Visit 16 (Week 242); n= 4	4.0 Ratio of BUN to creatinine Standard Deviation 18.49
Change From Baseline in BUN/Creatinine Ratio Visit 17 (Week 260); n= 4	2.0 Ratio of BUN to creatinine Standard Deviation 32.81
Change From Baseline in BUN/Creatinine Ratio Visit 18 (Week 277); n= 2	3.0 Ratio of BUN to creatinine Standard Deviation 11.31
Change From Baseline in BUN/Creatinine Ratio Withdrawal visit; n= 78	4.2 Ratio of BUN to creatinine Standard Deviation 23.96
Change From Baseline in BUN/Creatinine Ratio Follow up visit; n= 60	0.4 Ratio of BUN to creatinine Standard Deviation 22.68

PRIMARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

Blood samples were collected from participants for evaluation of change from Baseline in clinical chemistry parameters including calcium, chloride, CO2, glucose, potassium, magnesium, sodium and BUN. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; visit 2 (Week 13); n= 86	-0.011 Millimoles per liter (mmol/L) Standard Deviation 0.1067
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; visit 7 (Week 86); n= 54	-0.016 Millimoles per liter (mmol/L) Standard Deviation 0.0911
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; visit 4 (Week 39); n= 70	1.5 Millimoles per liter (mmol/L) Standard Deviation 2.80
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; visit 17 (Week 260); n= 4	3.5 Millimoles per liter (mmol/L) Standard Deviation 3.11
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; visit 17 (Week 260); n= 4	-0.5 Millimoles per liter (mmol/L) Standard Deviation 0.58
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; visit 16 (Week 242); n= 4	0.30 Millimoles per liter (mmol/L) Standard Deviation 0.294
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; visit 16 (Week 242); n= 4	-0.008 Millimoles per liter (mmol/L) Standard Deviation 0.1075
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; visit 17 (Week 260); n= 4	0.053 Millimoles per liter (mmol/L) Standard Deviation 0.1258
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; visit 13 (Week 190); n= 17	0.6 Millimoles per liter (mmol/L) Standard Deviation 1.73
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; withdrawal visit; n= 79	0.6 Millimoles per liter (mmol/L) Standard Deviation 2.89
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; visit 1 (Screening); n= 82	-0.028 Millimoles per liter (mmol/L) Standard Deviation 0.0940
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; visit 3 (Week 26); n= 74	-0.026 Millimoles per liter (mmol/L) Standard Deviation 0.1061
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; visit 4 (Week 39); n= 69	-0.025 Millimoles per liter (mmol/L) Standard Deviation 0.1024
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; visit 5 (Week 52); n= 64	-0.026 Millimoles per liter (mmol/L) Standard Deviation 0.1100
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; visit 6 (Week 69); n= 61	-0.019 Millimoles per liter (mmol/L) Standard Deviation 0.0942
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; visit 8 (Week 104); n= 42	-0.008 Millimoles per liter (mmol/L) Standard Deviation 0.0975
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; visit 9 (Week 121); n= 39	-0.024 Millimoles per liter (mmol/L) Standard Deviation 0.1096
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; visit 10 (Week 138); n= 36	-0.038 Millimoles per liter (mmol/L) Standard Deviation 0.1335
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; visit 11 (Week 156); n= 30	-0.053 Millimoles per liter (mmol/L) Standard Deviation 0.1181
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; visit 12 (Week 173); n= 23	-0.059 Millimoles per liter (mmol/L) Standard Deviation 0.1031
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; visit 13 (Week 190); n= 19	-0.074 Millimoles per liter (mmol/L) Standard Deviation 0.1000
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; visit 14 (Week 208); n= 10	-0.094 Millimoles per liter (mmol/L) Standard Deviation 0.0950
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; visit 15 (Week 225); n= 5	-0.108 Millimoles per liter (mmol/L) Standard Deviation 0.0858
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; visit 16 (Week 242); n= 4	-0.093 Millimoles per liter (mmol/L) Standard Deviation 0.0877
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; visit 17 (Week 260); n= 4	-0.073 Millimoles per liter (mmol/L) Standard Deviation 0.0670
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; visit 18 (Week 277); n= 2	-0.125 Millimoles per liter (mmol/L) Standard Deviation 0.02122
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; withdrawal visit; n= 78	-0.033 Millimoles per liter (mmol/L) Standard Deviation 0.1148
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Calcium; follow up visit; n= 60	-0.050 Millimoles per liter (mmol/L) Standard Deviation 0.1059
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; visit 1 (Screening); n= 83	0.5 Millimoles per liter (mmol/L) Standard Deviation 2.88
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; visit 2 (Week 13); n= 87	0.4 Millimoles per liter (mmol/L) Standard Deviation 2.73
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; visit 3 (Week 26); n=75	0.1 Millimoles per liter (mmol/L) Standard Deviation 2.79
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; visit 5 (Week 52); n= 65	1.2 Millimoles per liter (mmol/L) Standard Deviation 3.58
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; visit 6 (Week 69); n= 62	0.4 Millimoles per liter (mmol/L) Standard Deviation 2.68
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; visit 7 (Week 86); n= 54	1.5 Millimoles per liter (mmol/L) Standard Deviation 3.34
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; visit 8 (Week 104); n= 42	1.3 Millimoles per liter (mmol/L) Standard Deviation 2.83
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; visit 9 (Week 121); n= 39	1.4 Millimoles per liter (mmol/L) Standard Deviation 3.28
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; visit 10 (Week 138); n= 36	1.2 Millimoles per liter (mmol/L) Standard Deviation 3.35
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; visit 11 (Week 156); n= 30	2.0 Millimoles per liter (mmol/L) Standard Deviation 2.99
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; visit 12 (Week 173); n= 23	1.6 Millimoles per liter (mmol/L) Standard Deviation 2.74
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; visit 13 (Week 190); n= 19	2.4 Millimoles per liter (mmol/L) Standard Deviation 2.09
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; visit 14 (Week 208); n= 10	1.2 Millimoles per liter (mmol/L) Standard Deviation 2.49
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; visit 15 (Week 225); n= 5	1.2 Millimoles per liter (mmol/L) Standard Deviation 3.11
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; visit 16 (Week 242); n= 4	2.0 Millimoles per liter (mmol/L) Standard Deviation 2.00
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; visit 18 (Week 277); n= 2	-0.5 Millimoles per liter (mmol/L) Standard Deviation 0.71
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Chloride; follow up visit; n= 60	-0.0 Millimoles per liter (mmol/L) Standard Deviation 2.79
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; visit 1 (Screening); n= 82	-0.2 Millimoles per liter (mmol/L) Standard Deviation 3.07
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; visit 2 (Week 13); n= 86	0.3 Millimoles per liter (mmol/L) Standard Deviation 2.42
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; visit 3 (Week 26); n= 74	0.5 Millimoles per liter (mmol/L) Standard Deviation 2.82
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; visit 4 (Week 39); n= 69	-0.2 Millimoles per liter (mmol/L) Standard Deviation 3.03
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; visit 5 (Week 52); n= 64	-0.2 Millimoles per liter (mmol/L) Standard Deviation 2.88
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; visit 6 (Week 69); n= 61	-0.5 Millimoles per liter (mmol/L) Standard Deviation 2.99
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; visit 7 (Week 86); n= 54	-0.6 Millimoles per liter (mmol/L) Standard Deviation 2.71
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; visit 8 (Week 104); n= 42	-0.6 Millimoles per liter (mmol/L) Standard Deviation 2.64
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; visit 9 (Week 121); n= 39	-1.0 Millimoles per liter (mmol/L) Standard Deviation 3.02
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; visit 10 (Week 138); n= 36	-0.9 Millimoles per liter (mmol/L) Standard Deviation 3.42
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; visit 11 (Week 156); n= 30	-1.0 Millimoles per liter (mmol/L) Standard Deviation 2.48
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; visit 12 (Week 173); n= 23	-0.9 Millimoles per liter (mmol/L) Standard Deviation 2.80
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; visit 13 (Week 190); n= 19	-1.5 Millimoles per liter (mmol/L) Standard Deviation 3.39
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; visit 14 (Week 208); n= 10	-3.6 Millimoles per liter (mmol/L) Standard Deviation 4.53
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; visit 15 (Week 225); n= 5	-2.4 Millimoles per liter (mmol/L) Standard Deviation 1.82
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; visit 16 (Week 242); n= 4	-1.0 Millimoles per liter (mmol/L) Standard Deviation 1.41
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; visit 18 (Week 277); n= 2	-0.5 Millimoles per liter (mmol/L) Standard Deviation 0.71
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; withdrawal visit; n= 78	-0.0 Millimoles per liter (mmol/L) Standard Deviation 2.33
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN CO2; follow up visit; n= 60	-0.8 Millimoles per liter (mmol/L) Standard Deviation 2.92
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; visit 1 (Screening); n= 83	0.20 Millimoles per liter (mmol/L) Standard Deviation 1.303
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; visit 2 (Week 13); n= 87	0.16 Millimoles per liter (mmol/L) Standard Deviation 0.933
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; visit 3 (Week 26); n= 75	0.17 Millimoles per liter (mmol/L) Standard Deviation 0.765
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; visit 4 (Week 39); n= 70	0.40 Millimoles per liter (mmol/L) Standard Deviation 1.259
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; visit 5 (Week 52); n= 65	0.23 Millimoles per liter (mmol/L) Standard Deviation 0.814
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; visit 6 (Week 69); n= 62	0.25 Millimoles per liter (mmol/L) Standard Deviation 1.103
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; visit 7 (Week 86); n= 54	0.21 Millimoles per liter (mmol/L) Standard Deviation 0.985
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; visit 8 (Week 104); n= 42	0.21 Millimoles per liter (mmol/L) Standard Deviation 0.679
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; visit 9 (Week 121); n= 39	0.31 Millimoles per liter (mmol/L) Standard Deviation 1.073
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; visit 10 (Week 138); n= 36	0.30 Millimoles per liter (mmol/L) Standard Deviation 1.007
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; visit 11 (Week 156); n= 30	0.10 Millimoles per liter (mmol/L) Standard Deviation 0.511
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; visit 12 (Week 173); n= 23	-0.03 Millimoles per liter (mmol/L) Standard Deviation 0.820
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; visit 13 (Week 190); n= 19	0.21 Millimoles per liter (mmol/L) Standard Deviation 1.446
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; visit 14 (Week 208); n= 10	0.15 Millimoles per liter (mmol/L) Standard Deviation 0.412
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; visit 15 (Week 225); n= 5	0.38 Millimoles per liter (mmol/L) Standard Deviation 0.981
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; visit 16 (Week 242); n= 4	1.95 Millimoles per liter (mmol/L) Standard Deviation 3.313
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; visit 17 (Week 260); n= 4	-0.10 Millimoles per liter (mmol/L) Standard Deviation 0.648
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; visit 18 (Week 277); n= 2	-0.30 Millimoles per liter (mmol/L) Standard Deviation 0.141
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; withdrawal visit; n= 79	0.14 Millimoles per liter (mmol/L) Standard Deviation 1.035
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Glucose; follow up visit; n= 60	0.39 Millimoles per liter (mmol/L) Standard Deviation 1.162
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; visit 1 (Screening); n= 82	-0.04 Millimoles per liter (mmol/L) Standard Deviation 0.467
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; visit 2 (Week 13); n= 86	-0.07 Millimoles per liter (mmol/L) Standard Deviation 0.403
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; visit 3 (Week 26); n= 74	-0.09 Millimoles per liter (mmol/L) Standard Deviation 0.453
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; visit 4 (Week 39); n= 69	-0.11 Millimoles per liter (mmol/L) Standard Deviation 0.432
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; visit 5 (Week 52); n= 64	-0.13 Millimoles per liter (mmol/L) Standard Deviation 0.430
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; visit 6 (Week 69); n= 61	-0.21 Millimoles per liter (mmol/L) Standard Deviation 0.420
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; visit 7 (Week 86); n= 54	-0.13 Millimoles per liter (mmol/L) Standard Deviation 0.411
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; visit 8 (Week 104); n= 42	-0.05 Millimoles per liter (mmol/L) Standard Deviation 0.433
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; visit 9 (Week 121); n= 39	-0.09 Millimoles per liter (mmol/L) Standard Deviation 0.376
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; visit 10 (Week 138); n= 36	-0.07 Millimoles per liter (mmol/L) Standard Deviation 0.388
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; visit 11 (Week 156); n= 30	-0.16 Millimoles per liter (mmol/L) Standard Deviation 0.390
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; visit 12 (Week 173); n= 23	-0.13 Millimoles per liter (mmol/L) Standard Deviation 0.411
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; visit 13 (Week 190); n= 19	-0.02 Millimoles per liter (mmol/L) Standard Deviation 0.351
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; visit 14 (Week 208); n= 10	-0.16 Millimoles per liter (mmol/L) Standard Deviation 0.430
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; visit 15 (Week 225); n= 5	0.14 Millimoles per liter (mmol/L) Standard Deviation 0.321
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; visit 17 (Week 260); n= 4	0.25 Millimoles per liter (mmol/L) Standard Deviation 0.351
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; visit 18 (Week 277); n= 2	0.10 Millimoles per liter (mmol/L) Standard Deviation 0.424
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; withdrawal visit; n= 78	-0.04 Millimoles per liter (mmol/L) Standard Deviation 0.367
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Potassium; follow up visit; n= 60	-0.20 Millimoles per liter (mmol/L) Standard Deviation 0.478
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; visit 1 (Screening); n= 83	-0.017 Millimoles per liter (mmol/L) Standard Deviation 0.0576
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; visit 2 (Week 13); n= 87	-0.012 Millimoles per liter (mmol/L) Standard Deviation 0.0558
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; visit 3 (Week 26); n= 75	-0.007 Millimoles per liter (mmol/L) Standard Deviation 0.0619
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; visit 4 (Week 39); n= 70	-0.004 Millimoles per liter (mmol/L) Standard Deviation 0.0580
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; visit 5 (Week 52); n= 65	-0.008 Millimoles per liter (mmol/L) Standard Deviation 0.0625
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; visit 6 (Week 69); n= 62	-0.012 Millimoles per liter (mmol/L) Standard Deviation 0.0599
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; visit 7 (Week 86); n= 54	-0.018 Millimoles per liter (mmol/L) Standard Deviation 0.0627
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; visit 8 (Week 104); n= 42	0.007 Millimoles per liter (mmol/L) Standard Deviation 0.0632
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; visit 9 (Week 121); n= 39	-0.011 Millimoles per liter (mmol/L) Standard Deviation 0.0763
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; visit 10 (Week 138); n= 36	-0.007 Millimoles per liter (mmol/L) Standard Deviation 0.0543
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; visit 11 (Week 156); n= 30	0.005 Millimoles per liter (mmol/L) Standard Deviation 0.0651
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; visit 12 (Week 173); n= 23	-0.003 Millimoles per liter (mmol/L) Standard Deviation 0.0688
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; visit 13 (Week 190); n= 19	-0.000 Millimoles per liter (mmol/L) Standard Deviation 0.0627
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; visit 14 (Week 208); n= 10	-0.013 Millimoles per liter (mmol/L) Standard Deviation 0.0579
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; visit 15 (Week 225); n= 5	0.000 Millimoles per liter (mmol/L) Standard Deviation 0.0474
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; visit 18 (Week 277); n= 2	0.070 Millimoles per liter (mmol/L) Standard Deviation 0.0424
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; withdrawal visit; n= 79	-0.003 Millimoles per liter (mmol/L) Standard Deviation 0.0763
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Magnesium; follow up visit; n= 60	-0.007 Millimoles per liter (mmol/L) Standard Deviation 0.0727
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; visit 1 (Screening); n= 83	0.2 Millimoles per liter (mmol/L) Standard Deviation 2.88
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; visit 2 (Week 13); n= 80	0.2 Millimoles per liter (mmol/L) Standard Deviation 2.83
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; visit 3 (Week 26); n= 69	-0.2 Millimoles per liter (mmol/L) Standard Deviation 2.79
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; visit 4 (Week 39); n= 64	0.7 Millimoles per liter (mmol/L) Standard Deviation 2.37
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; visit 5 (Week 52); n= 59	0.5 Millimoles per liter (mmol/L) Standard Deviation 3.35
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; visit 6 (Week 69); n= 58	-0.2 Millimoles per liter (mmol/L) Standard Deviation 2.34
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; visit 7 (Week 86); n= 51	0.6 Millimoles per liter (mmol/L) Standard Deviation 3.03
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; visit 8 (Week 104); n= 39	0.9 Millimoles per liter (mmol/L) Standard Deviation 2.28
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; visit 9 (Week 121); n= 36	0.7 Millimoles per liter (mmol/L) Standard Deviation 2.78
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; visit 10 (Week 138); n= 35	0.3 Millimoles per liter (mmol/L) Standard Deviation 3.06
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; visit 11 (Week 156); n= 28	0.9 Millimoles per liter (mmol/L) Standard Deviation 3.47
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; visit 12 (Week 173); n= 21	0.7 Millimoles per liter (mmol/L) Standard Deviation 3.38
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; visit 14 (Week 208); n= 10	-1.2 Millimoles per liter (mmol/L) Standard Deviation 1.03
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; visit 15 (Week 225); n= 5	-0.4 Millimoles per liter (mmol/L) Standard Deviation 1.52
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; visit 16 (Week 242); n= 4	-0.8 Millimoles per liter (mmol/L) Standard Deviation 1.89
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; visit 17 (Week 260); n= 4	0.8 Millimoles per liter (mmol/L) Standard Deviation 2.63
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; visit 18 (Week 277); n= 2	-1.0 Millimoles per liter (mmol/L) Standard Deviation 0.00
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; withdrawal visit; n= 71	0.2 Millimoles per liter (mmol/L) Standard Deviation 2.85
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN Sodium; follow up visit; n= 53	-0.7 Millimoles per liter (mmol/L) Standard Deviation 2.45
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; visit 1 (Screening); n= 83	0.32 Millimoles per liter (mmol/L) Standard Deviation 1.317
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; visit 2 (Week 13); n= 80	0.44 Millimoles per liter (mmol/L) Standard Deviation 1.483
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; visit 3 (Week 26); n= 69	0.31 Millimoles per liter (mmol/L) Standard Deviation 1.287
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; visit 4 (Week 39); n= 64	0.22 Millimoles per liter (mmol/L) Standard Deviation 1.322
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; visit 5 (Week 52); n= 59	0.37 Millimoles per liter (mmol/L) Standard Deviation 1.643
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; visit 6 (Week 69); n= 58	0.13 Millimoles per liter (mmol/L) Standard Deviation 1.329
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; visit 7 (Week 86); n= 51	0.22 Millimoles per liter (mmol/L) Standard Deviation 1.467
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; visit 8 (Week 104); n= 39	0.22 Millimoles per liter (mmol/L) Standard Deviation 1.477
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; visit 9 (Week 121); n= 36	0.35 Millimoles per liter (mmol/L) Standard Deviation 1.444
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; visit 10 (Week 138); n= 35	0.18 Millimoles per liter (mmol/L) Standard Deviation 1.578
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; visit 11 (Week 156); n= 28	-0.06 Millimoles per liter (mmol/L) Standard Deviation 1.515
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; visit 12 (Week 173); n= 21	-0.40 Millimoles per liter (mmol/L) Standard Deviation 1.362
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; visit 13 (Week 190); n= 17	0.23 Millimoles per liter (mmol/L) Standard Deviation 1.088
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; visit 14 (Week 208); n= 10	-0.11 Millimoles per liter (mmol/L) Standard Deviation 1.604
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; visit 15 (Week 225); n= 5	-0.40 Millimoles per liter (mmol/L) Standard Deviation 1.416
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; visit 16 (Week 242); n= 4	0.80 Millimoles per liter (mmol/L) Standard Deviation 0.707
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; visit 17 (Week 260); n= 4	1.10 Millimoles per liter (mmol/L) Standard Deviation 2.889
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; visit 18 (Week 277); n= 2	0.50 Millimoles per liter (mmol/L) Standard Deviation 0.141
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; withdrawal visit; n= 71	0.49 Millimoles per liter (mmol/L) Standard Deviation 1.450
Change From Baseline in Calcium, Chloride, CO2, Glucose, Potassium, Magnesium, Sodium and BUN BUN; follow up visit; n= 53	0.14 Millimoles per liter (mmol/L) Standard Deviation 1.468

PRIMARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including absolute basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count and WBC count. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; visit 4 (Week 39); n= 65	0.001 Giga cells per liter (GI/L) Standard Deviation 0.0231
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; visit 8 (Week 104); n= 36	0.003 Giga cells per liter (GI/L) Standard Deviation 0.0165
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; visit 14 (Week 208); n= 10	-0.004 Giga cells per liter (GI/L) Standard Deviation 0.0165
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; visit 3 (Week 26); n= 71	-0.029 Giga cells per liter (GI/L) Standard Deviation 0.2191
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; visit 11 (Week 156); n= 29	-0.046 Giga cells per liter (GI/L) Standard Deviation 0.1846
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; visit 12 (Week 173); n= 24	-0.065 Giga cells per liter (GI/L) Standard Deviation 0.3068
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; visit 10 (Week 138); n= 33	0.412 Giga cells per liter (GI/L) Standard Deviation 1.9080
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; visit 16 (Week 242); n= 4	-0.818 Giga cells per liter (GI/L) Standard Deviation 0.9694
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; withdrawal visit; n= 78	-0.056 Giga cells per liter (GI/L) Standard Deviation 0.2713
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; follow up visit; n= 56	-0.091 Giga cells per liter (GI/L) Standard Deviation 0.3022
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; visit 1 (Screening); n= 84	-0.225 Giga cells per liter (GI/L) Standard Deviation 0.6631
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; visit 2 (Week 13); n= 85	-0.170 Giga cells per liter (GI/L) Standard Deviation 0.5506
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; visit 3 (Week 26); n= 71	-0.133 Giga cells per liter (GI/L) Standard Deviation 0.6123
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; visit 4 (Week 39); n= 65	-0.210 Giga cells per liter (GI/L) Standard Deviation 0.5412
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; visit 5 (Week 52); n= 60	-0.214 Giga cells per liter (GI/L) Standard Deviation 0.6446
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; visit 6 (Week 69); n= 58	-0.178 Giga cells per liter (GI/L) Standard Deviation 0.5194
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; visit 7 (Week 86); n= 53	-0.093 Giga cells per liter (GI/L) Standard Deviation 0.5793
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; visit 8 (Week 104); n= 36	-0.111 Giga cells per liter (GI/L) Standard Deviation 0.5839
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; visit 9 (Week 121); n= 35	0.008 Giga cells per liter (GI/L) Standard Deviation 0.8295
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; visit 10 (Week 138); n= 33	-0.177 Giga cells per liter (GI/L) Standard Deviation 0.6622
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; visit 11 (Week 156); n= 29	-0.324 Giga cells per liter (GI/L) Standard Deviation 0.6801
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; visit 12 (Week 173); n= 24	-0.226 Giga cells per liter (GI/L) Standard Deviation 0.5720
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; visit 13 (Week 190); n= 17	-0.325 Giga cells per liter (GI/L) Standard Deviation 0.7086
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; visit 14 (Week 208); n= 10	-0.354 Giga cells per liter (GI/L) Standard Deviation 0.6563
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; visit 15 (Week 225); n= 4	-0.990 Giga cells per liter (GI/L) Standard Deviation 0.6633
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; visit 17 (Week 260); n= 4	-0.993 Giga cells per liter (GI/L) Standard Deviation 0.7200
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; visit 18 (Week 277); n= 2	-1.465 Giga cells per liter (GI/L) Standard Deviation 0.6718
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; withdrawal visit; n= 78	-0.153 Giga cells per liter (GI/L) Standard Deviation 0.6466
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Lymphocytes; follow up visit; n= 56	-0.081 Giga cells per liter (GI/L) Standard Deviation 0.7105
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; visit 1 (Screening); n= 84	-0.043 Giga cells per liter (GI/L) Standard Deviation 0.1800
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; visit 2 (Week 13); n= 85	-0.009 Giga cells per liter (GI/L) Standard Deviation 0.1603
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; visit 3 (Week 26); n= 71	0.039 Giga cells per liter (GI/L) Standard Deviation 0.2031
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; visit 4 (Week 39); n= 65	-0.005 Giga cells per liter (GI/L) Standard Deviation 0.1940
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; visit 5 (Week 52); n= 60	-0.006 Giga cells per liter (GI/L) Standard Deviation 0.1876
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; visit 6 (Week 69); n= 58	0.018 Giga cells per liter (GI/L) Standard Deviation 0.1697
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; visit 7 (Week 86); n= 53	0.055 Giga cells per liter (GI/L) Standard Deviation 0.2375
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; visit 8 (Week 104); n= 36	-0.032 Giga cells per liter (GI/L) Standard Deviation 0.1911
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; visit 9 (Week 121); n= 35	0.023 Giga cells per liter (GI/L) Standard Deviation 0.1777
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; visit 10 (Week 138); n= 33	0.005 Giga cells per liter (GI/L) Standard Deviation 0.1796
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; visit 11 (Week 156); n= 29	-0.028 Giga cells per liter (GI/L) Standard Deviation 0.1982
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; visit 12 (Week 173); n= 24	-0.032 Giga cells per liter (GI/L) Standard Deviation 0.1648
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; visit 13 (Week 190); n= 17	-0.078 Giga cells per liter (GI/L) Standard Deviation 0.2279
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; visit 14 (Week 208); n= 10	-0.090 Giga cells per liter (GI/L) Standard Deviation 0.2821
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; visit 15 (Week 225); n= 4	-0.037 Giga cells per liter (GI/L) Standard Deviation 0.0450
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; visit 16 (Week 242); n= 4	-0.020 Giga cells per liter (GI/L) Standard Deviation 0.0829
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; visit 17 (Week 260); n= 4	0.025 Giga cells per liter (GI/L) Standard Deviation 0.1173
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; visit 18 (Week 277); n= 2	0.080 Giga cells per liter (GI/L) Standard Deviation 0.0000
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; withdrawal visit; n= 78	0.041 Giga cells per liter (GI/L) Standard Deviation 0.2417
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Monocytes; follow up visit; n= 56	-0.021 Giga cells per liter (GI/L) Standard Deviation 0.2091
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; visit 1 (Screening); n= 84	-0.108 Giga cells per liter (GI/L) Standard Deviation 1.6418
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; visit 2 (Week 13); n= 85	-0.354 Giga cells per liter (GI/L) Standard Deviation 1.4357
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; visit 3 (Week 26); n= 71	-0.175 Giga cells per liter (GI/L) Standard Deviation 1.4304
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; visit 4 (Week 39); n= 65	-0.582 Giga cells per liter (GI/L) Standard Deviation 1.5237
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; visit 5 (Week 52); n= 60	0.165 Giga cells per liter (GI/L) Standard Deviation 1.9517
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; visit 6 (Week 69); n= 58	-0.159 Giga cells per liter (GI/L) Standard Deviation 1.5356
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; visit 7 (Week 86); n= 53	-0.046 Giga cells per liter (GI/L) Standard Deviation 2.0418
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; visit 8 (Week 104); n= 36	-0.403 Giga cells per liter (GI/L) Standard Deviation 1.5416
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; visit 9 (Week 121); n= 35	0.519 Giga cells per liter (GI/L) Standard Deviation 1.9016
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; visit 11 (Week 156); n= 29	0.361 Giga cells per liter (GI/L) Standard Deviation 1.5062
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; visit 12 (Week 173); n= 24	0.144 Giga cells per liter (GI/L) Standard Deviation 1.7867
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; visit 13 (Week 190); n= 17	0.669 Giga cells per liter (GI/L) Standard Deviation 2.6453
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; visit 14 (Week 208); n= 10	0.113 Giga cells per liter (GI/L) Standard Deviation 1.7471
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; visit 15 (Week 225); n= 4	-0.825 Giga cells per liter (GI/L) Standard Deviation 1.9404
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; visit 16 (Week 242); n= 4	-1.183 Giga cells per liter (GI/L) Standard Deviation 1.9538
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; visit 17 (Week 260); n= 4	-0.990 Giga cells per liter (GI/L) Standard Deviation 2.1510
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; visit 18 (Week 277); n= 2	-2.210 Giga cells per liter (GI/L) Standard Deviation 2.6446
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; withdrawal visit; n= 78	0.209 Giga cells per liter (GI/L) Standard Deviation 1.6761
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Total neutrophils; follow up visit; n= 56	0.095 Giga cells per liter (GI/L) Standard Deviation 1.9626
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; visit 1 (Screening); n= 84	-1.7 Giga cells per liter (GI/L) Standard Deviation 34.31
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; visit 2 (Week 13); n= 88	3.7 Giga cells per liter (GI/L) Standard Deviation 38.83
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; visit 3 (Week 26); n= 73	5.1 Giga cells per liter (GI/L) Standard Deviation 44.34
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; visit 4 (Week 39); n= 68	2.9 Giga cells per liter (GI/L) Standard Deviation 45.75
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; visit 5 (Week 52); n= 63	4.1 Giga cells per liter (GI/L) Standard Deviation 37.72
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; visit 6 (Week 69); n= 62	6.9 Giga cells per liter (GI/L) Standard Deviation 39.48
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; visit 7 (Week 86); n= 55	1.5 Giga cells per liter (GI/L) Standard Deviation 50.29
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; visit 8 (Week 104); n= 41	4.5 Giga cells per liter (GI/L) Standard Deviation 43.95
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; visit 9 (Week 121); n= 35	8.7 Giga cells per liter (GI/L) Standard Deviation 45.39
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; visit 10 (Week 138); n= 36	6.8 Giga cells per liter (GI/L) Standard Deviation 42.37
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; visit 11 (Week 156); n= 31	1.9 Giga cells per liter (GI/L) Standard Deviation 37.92
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; visit 12 (Week 173); n= 24	9.7 Giga cells per liter (GI/L) Standard Deviation 37.95
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; visit 13 (Week 190); n= 18	7.0 Giga cells per liter (GI/L) Standard Deviation 37.15
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; visit 14 (Week 208); n= 10	18.9 Giga cells per liter (GI/L) Standard Deviation 69.95
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; visit 15 (Week 225); n= 4	-31.3 Giga cells per liter (GI/L) Standard Deviation 11.15
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; visit 16 (Week 242); n= 4	-9.0 Giga cells per liter (GI/L) Standard Deviation 63.92
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; visit 17 (Week 260); n= 4	-10.0 Giga cells per liter (GI/L) Standard Deviation 61.60
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; visit 18 (Week 277); n= 2	-19.0 Giga cells per liter (GI/L) Standard Deviation 100.41
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; withdrawal visit; n= 79	8.9 Giga cells per liter (GI/L) Standard Deviation 43.88
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Platelet count; follow up visit; n= 58	8.9 Giga cells per liter (GI/L) Standard Deviation 54.58
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; visit 1 (Screening); n= 84	0.30 Giga cells per liter (GI/L) Standard Deviation 6.496
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; visit 2 (Week 13); n= 78	-0.46 Giga cells per liter (GI/L) Standard Deviation 1.512
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; visit 3 (Week 26); n= 66	-0.24 Giga cells per liter (GI/L) Standard Deviation 1.354
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; visit 4 (Week 39); n= 59	-0.84 Giga cells per liter (GI/L) Standard Deviation 1.627
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; visit 5 (Week 52); n= 54	-0.05 Giga cells per liter (GI/L) Standard Deviation 1.989
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; visit 6 (Week 69); n= 54	-0.41 Giga cells per liter (GI/L) Standard Deviation 1.637
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; visit 7 (Week 86); n= 50	-0.12 Giga cells per liter (GI/L) Standard Deviation 2.059
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; visit 8 (Week 104); n= 33	-0.51 Giga cells per liter (GI/L) Standard Deviation 1.666
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; visit 9 (Week 121); n= 32	0.58 Giga cells per liter (GI/L) Standard Deviation 1.968
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; visit 10 (Week 138); n= 32	0.22 Giga cells per liter (GI/L) Standard Deviation 2.106
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; visit 11 (Week 156); n= 27	0.09 Giga cells per liter (GI/L) Standard Deviation 1.805
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; visit 12 (Week 173); n= 22	-0.15 Giga cells per liter (GI/L) Standard Deviation 1.971
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; visit 13 (Week 190); n= 15	0.43 Giga cells per liter (GI/L) Standard Deviation 2.804
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; visit 14 (Week 208); n= 10	-0.49 Giga cells per liter (GI/L) Standard Deviation 2.247
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; visit 15 (Week 225); n= 4	-2.00 Giga cells per liter (GI/L) Standard Deviation 2.608
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; visit 16 (Week 242); n= 4	-2.10 Giga cells per liter (GI/L) Standard Deviation 2.825
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; visit 17 (Week 260); n= 4	-2.03 Giga cells per liter (GI/L) Standard Deviation 2.941
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; visit 18 (Week 277); n= 2	-3.60 Giga cells per liter (GI/L) Standard Deviation 3.394
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; withdrawal visit; n= 70	0.13 Giga cells per liter (GI/L) Standard Deviation 1.757
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count WBC count; follow up visit; n= 50	-0.05 Giga cells per liter (GI/L) Standard Deviation 1.905
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; visit 1 (Screening); n= 84	-0.001 Giga cells per liter (GI/L) Standard Deviation 0.0203
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; visit 2 (Week 13); n= 85	-0.005 Giga cells per liter (GI/L) Standard Deviation 0.0159
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; visit 3 (Week 26); n= 71	-0.003 Giga cells per liter (GI/L) Standard Deviation 0.0197
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; visit 5 (Week 52); n= 60	0.002 Giga cells per liter (GI/L) Standard Deviation 0.0170
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; visit 6 (Week 69); n= 58	-0.002 Giga cells per liter (GI/L) Standard Deviation 0.0202
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; visit 7 (Week 86); n= 53	-0.002 Giga cells per liter (GI/L) Standard Deviation 0.0188
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; visit 9 (Week 121); n= 35	-0.002 Giga cells per liter (GI/L) Standard Deviation 0.0183
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; visit 10 (Week 138); n= 33	-0.002 Giga cells per liter (GI/L) Standard Deviation 0.0142
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; visit 11 (Week 156); n= 29	-0.001 Giga cells per liter (GI/L) Standard Deviation 0.0151
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; visit 12 (Week 173); n= 24	-0.004 Giga cells per liter (GI/L) Standard Deviation 0.0125
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; visit 13 (Week 190); n= 17	0.000 Giga cells per liter (GI/L) Standard Deviation 0.0255
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; visit 15 (Week 225); n= 4	-0.010 Giga cells per liter (GI/L) Standard Deviation 0.0115
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; visit 16 (Week 242); n= 4	-0.003 Giga cells per liter (GI/L) Standard Deviation 0.0050
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; visit 17 (Week 260); n= 4	-0.005 Giga cells per liter (GI/L) Standard Deviation 0.0129
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; visit 18 (Week 277); n= 2	0.000 Giga cells per liter (GI/L) Standard Deviation 0.0000
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; withdrawal visit; n= 78	0.001 Giga cells per liter (GI/L) Standard Deviation 0.0186
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Basophils; follow up visit; n= 56	-0.008 Giga cells per liter (GI/L) Standard Deviation 0.0190
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; visit 1 (Screening); n= 84	-0.011 Giga cells per liter (GI/L) Standard Deviation 0.1103
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; visit 2 (Week 13); n= 85	-0.018 Giga cells per liter (GI/L) Standard Deviation 0.2505
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; visit 4 (Week 39); n= 65	-0.050 Giga cells per liter (GI/L) Standard Deviation 0.2523
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; visit 5 (Week 52); n= 60	-0.065 Giga cells per liter (GI/L) Standard Deviation 0.3016
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; visit 6 (Week 69); n= 58	-0.025 Giga cells per liter (GI/L) Standard Deviation 0.1586
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; visit 7 (Week 86); n= 53	-0.016 Giga cells per liter (GI/L) Standard Deviation 0.1585
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; visit 8 (Week 104); n= 36	-0.020 Giga cells per liter (GI/L) Standard Deviation 0.1992
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; visit 9 (Week 121); n= 35	-0.015 Giga cells per liter (GI/L) Standard Deviation 0.1721
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; visit 10 (Week 138); n= 33	-0.052 Giga cells per liter (GI/L) Standard Deviation 0.1918
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; visit 13 (Week 190); n= 17	-0.104 Giga cells per liter (GI/L) Standard Deviation 0.3376
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; visit 14 (Week 208); n= 10	-0.158 Giga cells per liter (GI/L) Standard Deviation 0.1591
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; visit 15 (Week 225); n= 4	-0.140 Giga cells per liter (GI/L) Standard Deviation 0.0589
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; visit 16 (Week 242); n= 4	-0.070 Giga cells per liter (GI/L) Standard Deviation 0.1131
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; visit 17 (Week 260); n= 4	-0.055 Giga cells per liter (GI/L) Standard Deviation 0.0850
Change From Baseline in Absolute Basophils, Absolute Eosinophils, Absolute Lymphocytes, Absolute Monocytes, Absolute Total Neutrophils, Platelet Count and WBC Count Eosinophils; visit 18 (Week 277); n= 2	0.005 Giga cells per liter (GI/L) Standard Deviation 0.0636

PRIMARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including hemoglobin and MCHC. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; visit 11 (Week 156); n= 31	-3.4 G/L Standard Deviation 9.73
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; visit 1 (Screening); n= 85	-3.5 G/L Standard Deviation 6.75
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; visit 2 (Week 13); n= 89	-2.4 G/L Standard Deviation 7.87
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; visit 3 (Week 26); n= 74	-2.7 G/L Standard Deviation 7.59
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; visit 4 (Week 39); n= 69	-2.9 G/L Standard Deviation 9.09
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; visit 5 (Week 52); n= 64	-2.9 G/L Standard Deviation 9.51
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; visit 6 (Week 69); n= 62	-2.5 G/L Standard Deviation 9.83
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; visit 7 (Week 86); n= 55	-0.4 G/L Standard Deviation 8.75
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; visit 8 (Week 104); n= 41	-0.7 G/L Standard Deviation 8.35
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; visit 9 (Week 121); n= 36	-1.4 G/L Standard Deviation 8.68
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; visit 10 (Week 138); n= 36	0.1 G/L Standard Deviation 12.38
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; visit 12 (Week 173); n= 24	-2.2 G/L Standard Deviation 9.46
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; visit 13 (Week 190); n= 18	-4.3 G/L Standard Deviation 9.11
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; visit 14 (Week 208); n= 10	-8.0 G/L Standard Deviation 10.02
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; visit 15 (Week 225); n= 4	-6.0 G/L Standard Deviation 4.76
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; visit 16 (Week 242); n= 4	-9.5 G/L Standard Deviation 6.66
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; visit 17 (Week 260); n= 4	-8.0 G/L Standard Deviation 6.16
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; visit 18 (Week 277); n= 2	-10.5 G/L Standard Deviation 7.78
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; withdrawal visit; n= 79	-1.7 G/L Standard Deviation 9.69
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels Hemoglobin; follow up visit; n= 59	-2.3 G/L Standard Deviation 11.53
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; visit 1 (Screening); n= 85	-2.1 G/L Standard Deviation 12.61
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; visit 2 (Week 13); n= 89	1.4 G/L Standard Deviation 12.22
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; visit 3 (Week 26); n= 74	-1.1 G/L Standard Deviation 11.50
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; visit 4 (Week 39); n= 69	-4.6 G/L Standard Deviation 12.75
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; visit 5 (Week 52); n= 64	-5.4 G/L Standard Deviation 13.35
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; visit 6 (Week 69); n= 62	-4.8 G/L Standard Deviation 11.64
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; visit 7 (Week 86); n= 55	-5.8 G/L Standard Deviation 9.79
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; visit 8 (Week 104); n= 41	-9.1 G/L Standard Deviation 10.62
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; visit 9 (Week 121); n= 36	-6.9 G/L Standard Deviation 11.74
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; visit 10 (Week 138); n= 36	-9.6 G/L Standard Deviation 9.87
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; visit 11 (Week 156); n= 31	-10.1 G/L Standard Deviation 11.76
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; visit 12 (Week 173); n= 24	-10.7 G/L Standard Deviation 9.45
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; visit 13 (Week 190); n= 18	-15.2 G/L Standard Deviation 9.24
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; visit 14 (Week 208); n= 10	-21.5 G/L Standard Deviation 10.48
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; visit 15 (Week 225); n= 4	-16.3 G/L Standard Deviation 7.59
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; visit 16 (Week 242); n= 4	-14.5 G/L Standard Deviation 5.51
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; visit 17 (Week 260); n= 4	-16.0 G/L Standard Deviation 8.25
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; visit 18 (Week 277); n= 2	-4.5 G/L Standard Deviation 9.19
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; withdrawal visit; n= 79	-6.8 G/L Standard Deviation 9.61
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels MCHC; follow up visit; n= 59	-8.6 G/L Standard Deviation 10.18

PRIMARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including hematocrit. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Change From Baseline in Hematocrit Levels Visit 1 (Screening); n= 85	-0.0080 Proportion of red blood cells in blood Standard Deviation 0.02259
Change From Baseline in Hematocrit Levels Visit 2 (Week 13); n= 89	-0.0087 Proportion of red blood cells in blood Standard Deviation 0.02508
Change From Baseline in Hematocrit Levels Visit 3 (Week 26); n= 74	-0.0066 Proportion of red blood cells in blood Standard Deviation 0.02651
Change From Baseline in Hematocrit Levels Visit 4 (Week 39); n= 69	-0.0030 Proportion of red blood cells in blood Standard Deviation 0.02861
Change From Baseline in Hematocrit Levels Visit 5 (Week 52); n= 64	-0.0020 Proportion of red blood cells in blood Standard Deviation 0.02985
Change From Baseline in Hematocrit Levels Visit 6 (Week 69); n= 62	-0.0020 Proportion of red blood cells in blood Standard Deviation 0.02821
Change From Baseline in Hematocrit Levels Visit 7 (Week 86); n= 55	0.0063 Proportion of red blood cells in blood Standard Deviation 0.02627
Change From Baseline in Hematocrit Levels Visit 8 (Week 104); n= 41	0.0103 Proportion of red blood cells in blood Standard Deviation 0.02839
Change From Baseline in Hematocrit Levels Visit 9 (Week 121); n= 36	0.0053 Proportion of red blood cells in blood Standard Deviation 0.02819
Change From Baseline in Hematocrit Levels Visit 10 (Week 138); n= 36	0.0129 Proportion of red blood cells in blood Standard Deviation 0.04091
Change From Baseline in Hematocrit Levels Visit 11 (Week 156); n= 31	0.0025 Proportion of red blood cells in blood Standard Deviation 0.02755
Change From Baseline in Hematocrit Levels Visit 12 (Week 173); n= 24	0.0070 Proportion of red blood cells in blood Standard Deviation 0.03167
Change From Baseline in Hematocrit Levels Visit 13 (Week 190); n= 18	0.0061 Proportion of red blood cells in blood Standard Deviation 0.02857
Change From Baseline in Hematocrit Levels Visit 14 (Week 208); n= 10	0.0015 Proportion of red blood cells in blood Standard Deviation 0.03213
Change From Baseline in Hematocrit Levels Visit 15 (Week 225); n= 4	0.0050 Proportion of red blood cells in blood Standard Deviation 0.01857
Change From Baseline in Hematocrit Levels Visit 16 (Week 242); n= 4	-0.0097 Proportion of red blood cells in blood Standard Deviation 0.02017
Change From Baseline in Hematocrit Levels Visit 17 (Week 260); n= 4	-0.0040 Proportion of red blood cells in blood Standard Deviation 0.00841
Change From Baseline in Hematocrit Levels Visit 18 (Week 277); n= 2	-0.0270 Proportion of red blood cells in blood Standard Deviation 0.03677
Change From Baseline in Hematocrit Levels Withdrawal visit; n= 79	0.0034 Proportion of red blood cells in blood Standard Deviation 0.02926
Change From Baseline in Hematocrit Levels Follow up visit; n= 59	0.0039 Proportion of red blood cells in blood Standard Deviation 0.03501

PRIMARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including MCH. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Visit 1 (Screening); n= 85	-0.17 Picograms (Pg) Standard Deviation 0.910
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Visit 2 (Week 13); n= 89	-0.33 Picograms (Pg) Standard Deviation 1.058
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Visit 3 (Week 26); n= 74	-0.47 Picograms (Pg) Standard Deviation 0.809
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Visit 4 (Week 39); n= 69	-0.83 Picograms (Pg) Standard Deviation 1.238
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Visit 5 (Week 52); n= 64	-0.77 Picograms (Pg) Standard Deviation 1.087
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Visit 6 (Week 69); n= 62	-0.91 Picograms (Pg) Standard Deviation 1.317
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Visit 7 (Week 86); n= 55	-0.99 Picograms (Pg) Standard Deviation 1.227
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Visit 8 (Week 104); n= 41	-1.17 Picograms (Pg) Standard Deviation 1.503
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Visit 9 (Week 121); n= 36	-1.11 Picograms (Pg) Standard Deviation 1.551
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Visit 10 (Week 138); n= 36	-1.28 Picograms (Pg) Standard Deviation 1.282
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Visit 11 (Week 156); n= 31	-1.44 Picograms (Pg) Standard Deviation 1.065
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Visit 12 (Week 173); n= 24	-1.78 Picograms (Pg) Standard Deviation 1.380
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Visit 13 (Week 190); n= 18	-1.90 Picograms (Pg) Standard Deviation 1.251
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Visit 14 (Week 208); n= 10	-2.19 Picograms (Pg) Standard Deviation 1.883
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Visit 15 (Week 225); n= 4	-2.00 Picograms (Pg) Standard Deviation 1.291
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Visit 16 (Week 242); n= 4	-2.50 Picograms (Pg) Standard Deviation 1.669
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Visit 17 (Week 260); n= 4	-1.83 Picograms (Pg) Standard Deviation 1.382
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Visit 18 (Week 277); n= 2	-2.65 Picograms (Pg) Standard Deviation 0.354
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Withdrawal visit; n= 79	-1.11 Picograms (Pg) Standard Deviation 1.305
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels Follow up visit; n= 59	-1.08 Picograms (Pg) Standard Deviation 1.437

PRIMARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including MCV and MPV. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV; Visit 4 (Week 39); n= 69	-1.2 Femtoliter (fL) Standard Deviation 3.62
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV; visit 4 (Week 39); n= 67	-0.17 Femtoliter (fL) Standard Deviation 0.823
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV; visit 5 (Week 52); n= 61	-0.06 Femtoliter (fL) Standard Deviation 0.746
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV (Screening); Visit 1; n= 85	0.0 Femtoliter (fL) Standard Deviation 3.55
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV; Visit 2 (Week 13); n= 89	-1.5 Femtoliter (fL) Standard Deviation 3.63
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV; Visit 3 (Week 26); n= 74	-1.0 Femtoliter (fL) Standard Deviation 3.32
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV; Visit 5 (Week 52); n= 64	-0.8 Femtoliter (fL) Standard Deviation 3.71
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV; Visit 6 (Week 69); n= 62	-1.4 Femtoliter (fL) Standard Deviation 4.29
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV; Visit 7 (Week 86); n= 55	-1.2 Femtoliter (fL) Standard Deviation 3.56
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV; Visit 8 (Week 104); n= 41	-0.9 Femtoliter (fL) Standard Deviation 4.75
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV; Visit 9 (Week 121); n= 36	-1.4 Femtoliter (fL) Standard Deviation 4.00
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV; Visit 10 (Week 138); n= 36	-1.1 Femtoliter (fL) Standard Deviation 4.30
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV; Visit 11 (Week 156); n= 31	-1.5 Femtoliter (fL) Standard Deviation 4.18
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV; Visit 12 (Week 173); n= 24	-2.5 Femtoliter (fL) Standard Deviation 4.64
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV; Visit 13 (Week 190); n= 18	-1.2 Femtoliter (fL) Standard Deviation 4.40
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV; Visit 14 (Week 208); n= 10	-0.9 Femtoliter (fL) Standard Deviation 4.48
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV; Visit 15 (Week 225); n= 4	-1.5 Femtoliter (fL) Standard Deviation 1.73
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV; Visit 16 (Week 242); n= 4	-4.0 Femtoliter (fL) Standard Deviation 3.92
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV; Visit 17 (Week 260); n= 4	-1.3 Femtoliter (fL) Standard Deviation 2.63
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV; Visit 18 (Week 277); n= 2	-7.0 Femtoliter (fL) Standard Deviation 4.24
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV; Withdrawal visit; n= 79	-1.4 Femtoliter (fL) Standard Deviation 4.14
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MCV; Follow up visit; n= 59	-0.9 Femtoliter (fL) Standard Deviation 4.39
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV; visit 1 (Screening); n= 84	-0.12 Femtoliter (fL) Standard Deviation 0.715
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV: visit 2 (Week 13); n= 86	-0.10 Femtoliter (fL) Standard Deviation 0.756
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV: visit 3 (Week 26); n= 71	-0.08 Femtoliter (fL) Standard Deviation 0.612
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV; visit 6 (Week 69); n= 58	-0.03 Femtoliter (fL) Standard Deviation 0.654
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV; visit 7 (Week 86); n= 53	0.12 Femtoliter (fL) Standard Deviation 0.786
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV; visit 8 (Week 104); n= 38	0.01 Femtoliter (fL) Standard Deviation 0.902
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV: visit 9 (Week 121); n= 35	0.13 Femtoliter (fL) Standard Deviation 0.788
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV; visit 10 (Week 138); n= 34	0.06 Femtoliter (fL) Standard Deviation 0.773
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV; visit 11 (Week 156); n= 29	0.14 Femtoliter (fL) Standard Deviation 0.728
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV: visit 12 (Week 173); n= 24	0.04 Femtoliter (fL) Standard Deviation 0.944
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV; visit 13 (Week 190); n= 17	-0.09 Femtoliter (fL) Standard Deviation 0.766
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV; visit 14 (Week 208); n= 10	-0.37 Femtoliter (fL) Standard Deviation 0.455
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV; visit 15 (Week 225); n= 4	-0.33 Femtoliter (fL) Standard Deviation 1.053
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV; visit 16 (Week 242); n= 4	-0.75 Femtoliter (fL) Standard Deviation 0.802
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV; visit 17 (Week 260); n= 4	-0.17 Femtoliter (fL) Standard Deviation 0.670
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV; visit 18 (Week 277); n= 2	-1.15 Femtoliter (fL) Standard Deviation 0.071
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV; withdrawal visit; n= 78	0.19 Femtoliter (fL) Standard Deviation 0.902
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) Levels MPV; follow up visit; n= 57	0.12 Femtoliter (fL) Standard Deviation 0.859

PRIMARY outcome

Timeframe: Up to 5.8 years

Population: Safety Population

Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including RBC count. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Change From Baseline in RBC Count Visit 1 (Screening); n= 85	-0.10 Tetra cells per liter (TI/L) Standard Deviation 0.212
Change From Baseline in RBC Count Visit 2 (Week 13); n= 89	-0.03 Tetra cells per liter (TI/L) Standard Deviation 0.255
Change From Baseline in RBC Count Visit 3 (Week 26); n= 74	-0.03 Tetra cells per liter (TI/L) Standard Deviation 0.240
Change From Baseline in RBC Count Visit 4 (Week 39); n= 69	0.01 Tetra cells per liter (TI/L) Standard Deviation 0.272
Change From Baseline in RBC Count Visit 5 (Week 52); n= 64	0.00 Tetra cells per liter (TI/L) Standard Deviation 0.311
Change From Baseline in RBC Count Visit 6 (Week 69); n= 62	0.04 Tetra cells per liter (TI/L) Standard Deviation 0.300
Change From Baseline in RBC Count Visit 7 (Week 86); n= 55	0.12 Tetra cells per liter (TI/L) Standard Deviation 0.260
Change From Baseline in RBC Count Visit 8 (Week 104); n= 41	0.14 Tetra cells per liter (TI/L) Standard Deviation 0.280
Change From Baseline in RBC Count Visit 9 (Week 121); n= 36	0.11 Tetra cells per liter (TI/L) Standard Deviation 0.299
Change From Baseline in RBC Count Visit 10 (Week 138); n= 36	0.19 Tetra cells per liter (TI/L) Standard Deviation 0.445
Change From Baseline in RBC Count Visit 11 (Week 156); n= 31	0.09 Tetra cells per liter (TI/L) Standard Deviation 0.344
Change From Baseline in RBC Count Visit 12 (Week 173); n= 24	0.18 Tetra cells per liter (TI/L) Standard Deviation 0.385
Change From Baseline in RBC Count Visit 13 (Week 190); n= 18	0.12 Tetra cells per liter (TI/L) Standard Deviation 0.343
Change From Baseline in RBC Count Visit 14 (Week 208); n= 10	0.05 Tetra cells per liter (TI/L) Standard Deviation 0.366
Change From Baseline in RBC Count Visit 15 (Week 225); n= 4	0.13 Tetra cells per liter (TI/L) Standard Deviation 0.206
Change From Baseline in RBC Count Visit 16 (Week 242); n= 4	0.10 Tetra cells per liter (TI/L) Standard Deviation 0.216
Change From Baseline in RBC Count Visit 17 (Week 260); n= 4	0.00 Tetra cells per liter (TI/L) Standard Deviation 0.082
Change From Baseline in RBC Count Visit 18 (Week 277); n= 2	0.05 Tetra cells per liter (TI/L) Standard Deviation 0.212
Change From Baseline in RBC Count Withdrawal visit; n= 79	0.10 Tetra cells per liter (TI/L) Standard Deviation 0.327
Change From Baseline in RBC Count Follow up visit; n= 59	0.07 Tetra cells per liter (TI/L) Standard Deviation 0.409

PRIMARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

Blood samples were collected from participants for evaluation of change from Baseline in clinical hematology parameters including percent basophils, eosinophils, lymphocytes, monocytes, neutrophils and RDW. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; visit 4 (Week 39); n= 65	0.07 Percent of blood components Standard Deviation 0.393
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; visit 12 (Week 173); n= 24	-0.06 Percent of blood components Standard Deviation 0.253
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; visit 12 (Week 173); n= 24	-0.70 Percent of blood components Standard Deviation 5.548
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; visit 16 (Week 242); n= 4	-0.43 Percent of blood components Standard Deviation 1.628
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; visit 18 (Week 277); n= 2	2.00 Percent of blood components Standard Deviation 7.354
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; visit 15 (Week 225); n= 4	0.28 Percent of blood components Standard Deviation 0.550
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; visit 16 (Week 242); n= 4	3.95 Percent of blood components Standard Deviation 6.855
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; visit 1 (Screening); n= 84	-0.00 Percent of blood components Standard Deviation 0.312
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; visit 2 (Week 13); n= 85	-0.06 Percent of blood components Standard Deviation 0.243
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; visit 3 (Week 26); n= 71	-0.03 Percent of blood components Standard Deviation 0.305
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; visit 5 (Week 52); n= 60	0.04 Percent of blood components Standard Deviation 0.279
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; visit 6 (Week 69); n= 58	-0.02 Percent of blood components Standard Deviation 0.315
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; visit 7 (Week 86); n= 53	-0.02 Percent of blood components Standard Deviation 0.302
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; visit 8 (Week 104); n= 36	0.11 Percent of blood components Standard Deviation 0.271
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; visit 9 (Week 121); n= 35	-0.06 Percent of blood components Standard Deviation 0.239
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; visit 10 (Week 138); n= 33	-0.02 Percent of blood components Standard Deviation 0.255
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; visit 11 (Week 156); n= 29	-0.00 Percent of blood components Standard Deviation 0.267
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; visit 13 (Week 190); n= 17	-0.01 Percent of blood components Standard Deviation 0.339
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; visit 14 (Week 208); n= 10	-0.03 Percent of blood components Standard Deviation 0.283
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; visit 15 (Week 225); n= 4	0.00 Percent of blood components Standard Deviation 0.216
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; visit 16 (Week 242); n= 4	0.03 Percent of blood components Standard Deviation 0.126
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; visit 17 (Week 260); n= 4	0.03 Percent of blood components Standard Deviation 0.050
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; visit 18 (Week 277); n= 2	0.25 Percent of blood components Standard Deviation 0.212
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; withdrawal visit; n= 78	0.01 Percent of blood components Standard Deviation 0.291
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent basophils; follow up visit; n= 56	-0.13 Percent of blood components Standard Deviation 0.304
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; visit 1 (Screening); n= 84	-0.06 Percent of blood components Standard Deviation 1.745
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; visit 2 (Week 13); n= 85	-0.00 Percent of blood components Standard Deviation 3.214
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; visit 3 (Week 26); n= 71	-0.29 Percent of blood components Standard Deviation 2.773
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; visit 4 (Week 39); n= 65	-0.44 Percent of blood components Standard Deviation 3.339
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; visit 5 (Week 52); n= 60	-0.77 Percent of blood components Standard Deviation 4.046
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; visit 6 (Week 69); n= 58	-0.26 Percent of blood components Standard Deviation 2.630
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; visit 7 (Week 86); n= 53	-0.30 Percent of blood components Standard Deviation 2.634
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; visit 8 (Week 104); n= 36	-0.04 Percent of blood components Standard Deviation 3.003
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; visit 9 (Week 121); n= 35	-0.47 Percent of blood components Standard Deviation 2.653
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; visit 10 (Week 138); n= 33	-0.92 Percent of blood components Standard Deviation 2.942
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; visit 11 (Week 156); n= 29	-0.79 Percent of blood components Standard Deviation 2.484
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; visit 13 (Week 190); n= 17	-1.38 Percent of blood components Standard Deviation 5.539
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; visit 14 (Week 208); n= 10	-2.49 Percent of blood components Standard Deviation 2.975
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; visit 15 (Week 225); n= 4	-1.53 Percent of blood components Standard Deviation 1.565
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; visit 17 (Week 260); n= 4	0.00 Percent of blood components Standard Deviation 1.359
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; visit 18 (Week 277); n= 2	1.65 Percent of blood components Standard Deviation 0.636
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; withdrawal visit; n= 78	-0.83 Percent of blood components Standard Deviation 3.466
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent eosinophils; follow up visit; n= 56	-1.30 Percent of blood components Standard Deviation 3.804
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; visit 1 (Screening); n= 84	-2.21 Percent of blood components Standard Deviation 8.440
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; visit 2 (Week 13); n= 85	-0.40 Percent of blood components Standard Deviation 9.550
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; visit 3 (Week 26); n= 71	-1.14 Percent of blood components Standard Deviation 10.820
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; visit 4 (Week 39); n= 65	0.27 Percent of blood components Standard Deviation 9.306
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; visit 5 (Week 52); n= 60	-2.58 Percent of blood components Standard Deviation 11.216
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; visit 6 (Week 69); n= 58	-1.26 Percent of blood components Standard Deviation 8.119
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; visit 7 (Week 86); n= 53	-0.53 Percent of blood components Standard Deviation 11.226
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; visit 8 (Week 104); n= 36	0.69 Percent of blood components Standard Deviation 9.013
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; visit 9 (Week 121); n= 35	-2.27 Percent of blood components Standard Deviation 11.733
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; visit 10 (Week 138); n= 33	-3.91 Percent of blood components Standard Deviation 8.960
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; visit 11 (Week 156); n= 29	-4.52 Percent of blood components Standard Deviation 9.015
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; visit 12 (Week 173); n= 24	-3.19 Percent of blood components Standard Deviation 9.398
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; visit 13 (Week 190); n= 17	-4.73 Percent of blood components Standard Deviation 12.168
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; visit 14 (Week 208); n= 10	-3.72 Percent of blood components Standard Deviation 5.911
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; visit 15 (Week 225); n= 4	-6.58 Percent of blood components Standard Deviation 3.848
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; visit 16 (Week 242); n= 4	-3.88 Percent of blood components Standard Deviation 10.160
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; visit 17 (Week 260); n= 4	-5.85 Percent of blood components Standard Deviation 4.886
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; visit 18 (Week 277); n= 2	-8.10 Percent of blood components Standard Deviation 3.818
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; withdrawal visit; n= 78	-2.60 Percent of blood components Standard Deviation 10.978
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent lymphocytes; follow up visit; n= 56	-0.81 Percent of blood components Standard Deviation 12.709
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; visit 1 (Screening); n= 84	-0.33 Percent of blood components Standard Deviation 3.048
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; visit 2 (Week 13); n= 85	0.27 Percent of blood components Standard Deviation 2.720
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; visit 3 (Week 26); n= 71	0.86 Percent of blood components Standard Deviation 3.274
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; visit 4 (Week 39); n= 65	0.76 Percent of blood components Standard Deviation 3.286
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; visit 5 (Week 52); n= 60	-0.01 Percent of blood components Standard Deviation 3.058
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; visit 6 (Week 69); n= 58	0.64 Percent of blood components Standard Deviation 2.834
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; visit 7 (Week 86); n= 53	0.94 Percent of blood components Standard Deviation 3.148
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; visit 8 (Week 104); n= 36	0.04 Percent of blood components Standard Deviation 3.458
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; visit 9 (Week 121); n= 35	-0.11 Percent of blood components Standard Deviation 2.895
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; visit 10 (Week 138); n= 33	0.15 Percent of blood components Standard Deviation 3.160
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; visit 11 (Week 156); n= 29	-0.27 Percent of blood components Standard Deviation 3.007
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; visit 12 (Week 173); n= 24	-0.44 Percent of blood components Standard Deviation 2.687
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; visit 13 (Week 190); n= 17	-1.43 Percent of blood components Standard Deviation 2.909
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; visit 14 (Week 208); n= 10	-0.71 Percent of blood components Standard Deviation 5.153
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; visit 15 (Week 225); n= 4	1.08 Percent of blood components Standard Deviation 1.090
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; visit 16 (Week 242); n= 4	1.25 Percent of blood components Standard Deviation 1.686
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; visit 17 (Week 260); n= 4	2.03 Percent of blood components Standard Deviation 2.219
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; visit 18 (Week 277); n= 2	4.20 Percent of blood components Standard Deviation 2.687
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; withdrawal visit; n= 78	0.48 Percent of blood components Standard Deviation 3.355
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent monocytes; follow up visit; n= 56	-0.35 Percent of blood components Standard Deviation 3.293
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; visit 1 (Screening); n= 84	2.60 Percent of blood components Standard Deviation 11.021
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; visit 2 (Week 13); n= 85	0.19 Percent of blood components Standard Deviation 11.584
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; visit 3 (Week 26); n= 71	0.60 Percent of blood components Standard Deviation 12.994
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; visit 4 (Week 39); n= 65	-0.66 Percent of blood components Standard Deviation 11.810
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; visit 5 (Week 52); n= 60	3.31 Percent of blood components Standard Deviation 14.222
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; visit 6 (Week 69); n= 58	0.90 Percent of blood components Standard Deviation 10.552
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; visit 7 (Week 86); n= 53	-0.09 Percent of blood components Standard Deviation 14.427
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; visit 8 (Week 104); n= 37	-0.81 Percent of blood components Standard Deviation 11.595
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; visit 9 (Week 121); n= 35	2.91 Percent of blood components Standard Deviation 14.604
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; visit 10 (Week 138); n= 33	4.70 Percent of blood components Standard Deviation 12.464
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; visit 11 (Week 156); n= 29	5.58 Percent of blood components Standard Deviation 10.691
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; visit 12 (Week 173); n= 24	4.39 Percent of blood components Standard Deviation 13.509
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; visit 13 (Week 190); n= 17	7.55 Percent of blood components Standard Deviation 16.056
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; visit 14 (Week 208); n= 10	6.95 Percent of blood components Standard Deviation 7.643
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; visit 15 (Week 225); n= 4	7.03 Percent of blood components Standard Deviation 5.900
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; visit 16 (Week 242); n= 4	3.03 Percent of blood components Standard Deviation 10.460
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; visit 17 (Week 260); n= 4	3.80 Percent of blood components Standard Deviation 3.990
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; withdrawal visit; n= 78	2.94 Percent of blood components Standard Deviation 13.146
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels Percent neutrophils; follow up visit; n= 56	2.58 Percent of blood components Standard Deviation 14.680
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; visit 1 (Screening); n= 85	0.41 Percent of blood components Standard Deviation 1.398
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; visit 2 (Week 13); n= 89	-0.07 Percent of blood components Standard Deviation 1.532
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; visit 3 (Week 26); n= 74	0.05 Percent of blood components Standard Deviation 0.924
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; visit 4 (Week 39); n= 69	0.47 Percent of blood components Standard Deviation 1.637
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; visit 5 (Week 52); n= 64	0.35 Percent of blood components Standard Deviation 1.598
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; visit 6 (Week 69); n= 62	0.05 Percent of blood components Standard Deviation 1.437
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; visit 7 (Week 86); n= 55	0.05 Percent of blood components Standard Deviation 1.109
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; visit 8 (Week 104); n= 41	0.32 Percent of blood components Standard Deviation 1.386
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; visit 9 (Week 121); n= 36	-0.19 Percent of blood components Standard Deviation 1.084
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; visit 10 (Week 138); n= 36	0.22 Percent of blood components Standard Deviation 0.885
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; visit 11 (Week 156); n= 31	0.94 Percent of blood components Standard Deviation 1.760
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; visit 12 (Week 173); n= 24	0.41 Percent of blood components Standard Deviation 1.292
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; visit 13 (Week 190); n= 18	0.88 Percent of blood components Standard Deviation 0.919
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; visit 14 (Week 208); n= 10	1.98 Percent of blood components Standard Deviation 1.605
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; visit 17 (Week 260); n= 4	2.50 Percent of blood components Standard Deviation 2.202
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; visit 18 (Week 277); n= 2	2.05 Percent of blood components Standard Deviation 0.495
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; withdrawal visit; n= 79	0.10 Percent of blood components Standard Deviation 1.097
Change From Baseline in Percent Basophils, Percent Eosinophils, Percent Lymphocytes, Percent Monocytes, Percent Neutrophils and RBC Distribution Width (RDW) Levels RDW; follow up visit; n= 59	0.27 Percent of blood components Standard Deviation 1.235

PRIMARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

Urine samples were collected from participants for evaluation of change from Baseline in urinalysis parameters including albumin creatinine ratio. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Change From Baseline in Urine Albumin Creatinine Ratio Visit 1 (Screening); n= 39	-0.57 Mg of urine albumin/ mmol of creatinine Standard Deviation 3.573
Change From Baseline in Urine Albumin Creatinine Ratio Visit 2 (Week 13); n= 72	-0.07 Mg of urine albumin/ mmol of creatinine Standard Deviation 3.172
Change From Baseline in Urine Albumin Creatinine Ratio Visit 3 (Week 26); n= 54	0.15 Mg of urine albumin/ mmol of creatinine Standard Deviation 3.678
Change From Baseline in Urine Albumin Creatinine Ratio Visit 17 (Week 260); n= 3	-0.33 Mg of urine albumin/ mmol of creatinine Standard Deviation 0.321
Change From Baseline in Urine Albumin Creatinine Ratio Visit 18 (Week 277); n= 2	-0.50 Mg of urine albumin/ mmol of creatinine Standard Deviation 0.990
Change From Baseline in Urine Albumin Creatinine Ratio Visit 6 (Week 69); n= 46	-0.53 Mg of urine albumin/ mmol of creatinine Standard Deviation 3.489
Change From Baseline in Urine Albumin Creatinine Ratio Visit 7 (Week 86); n= 47	0.07 Mg of urine albumin/ mmol of creatinine Standard Deviation 6.062
Change From Baseline in Urine Albumin Creatinine Ratio Visit 8 (Week 104); n= 32	-0.75 Mg of urine albumin/ mmol of creatinine Standard Deviation 4.508
Change From Baseline in Urine Albumin Creatinine Ratio Visit 4 (Week 39); n= 53	-0.64 Mg of urine albumin/ mmol of creatinine Standard Deviation 3.241
Change From Baseline in Urine Albumin Creatinine Ratio Visit 5 (Week 52); n= 52	-0.69 Mg of urine albumin/ mmol of creatinine Standard Deviation 3.065
Change From Baseline in Urine Albumin Creatinine Ratio Visit 9 (Week 121); n= 30	-0.89 Mg of urine albumin/ mmol of creatinine Standard Deviation 5.421
Change From Baseline in Urine Albumin Creatinine Ratio Visit 10 (Week 138); n= 26	-1.05 Mg of urine albumin/ mmol of creatinine Standard Deviation 4.236
Change From Baseline in Urine Albumin Creatinine Ratio Visit 11 (Week 156); n= 22	-0.65 Mg of urine albumin/ mmol of creatinine Standard Deviation 2.494
Change From Baseline in Urine Albumin Creatinine Ratio Visit 12 (Week 173); n= 19	-1.81 Mg of urine albumin/ mmol of creatinine Standard Deviation 5.060
Change From Baseline in Urine Albumin Creatinine Ratio Visit 13 (Week 190); n= 10	-0.59 Mg of urine albumin/ mmol of creatinine Standard Deviation 1.748
Change From Baseline in Urine Albumin Creatinine Ratio Visit 14 (Week 208); n= 8	-1.70 Mg of urine albumin/ mmol of creatinine Standard Deviation 4.032
Change From Baseline in Urine Albumin Creatinine Ratio Visit 15 (Week 225); n= 4	0.13 Mg of urine albumin/ mmol of creatinine Standard Deviation 0.981
Change From Baseline in Urine Albumin Creatinine Ratio Visit 16 (Week 242); n= 3	-0.33 Mg of urine albumin/ mmol of creatinine Standard Deviation 0.153
Change From Baseline in Urine Albumin Creatinine Ratio Withdrawal visit; n= 63	-0.35 Mg of urine albumin/ mmol of creatinine Standard Deviation 3.874
Change From Baseline in Urine Albumin Creatinine Ratio Follow up visit; n= 48	-0.62 Mg of urine albumin/ mmol of creatinine Standard Deviation 3.515

PRIMARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

Urine samples were collected from participants for evaluation of change from Baseline in urinalysis parameters including albumin levels. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Change From Baseline in Urine Albumin Levels Visit 3 (Week 26); n= 54	-17.1 Milligrams per liter (mg/L) Standard Deviation 92.34
Change From Baseline in Urine Albumin Levels Visit 4 (Week 39); n= 53	-21.0 Milligrams per liter (mg/L) Standard Deviation 94.25
Change From Baseline in Urine Albumin Levels Visit 1 (Screening); n= 39	-5.2 Milligrams per liter (mg/L) Standard Deviation 57.64
Change From Baseline in Urine Albumin Levels Visit 2 (Week 13); n= 72	-1.8 Milligrams per liter (mg/L) Standard Deviation 48.39
Change From Baseline in Urine Albumin Levels Visit 5 (Week 52); n= 52	-21.6 Milligrams per liter (mg/L) Standard Deviation 94.87
Change From Baseline in Urine Albumin Levels Visit 6 (Week 69); n= 46	-15.7 Milligrams per liter (mg/L) Standard Deviation 56.98
Change From Baseline in Urine Albumin Levels Visit 7 (Week 86); n= 47	7.7 Milligrams per liter (mg/L) Standard Deviation 131.03
Change From Baseline in Urine Albumin Levels Visit 8 (Week 104); n= 32	-8.1 Milligrams per liter (mg/L) Standard Deviation 59.50
Change From Baseline in Urine Albumin Levels Visit 9 (Week 121); n= 30	-14.7 Milligrams per liter (mg/L) Standard Deviation 61.73
Change From Baseline in Urine Albumin Levels Visit 10 (Week 138); n= 26	-16.0 Milligrams per liter (mg/L) Standard Deviation 66.79
Change From Baseline in Urine Albumin Levels Visit 11 (Week 156); n= 22	-7.4 Milligrams per liter (mg/L) Standard Deviation 35.40
Change From Baseline in Urine Albumin Levels Visit 12 (Week 173); n= 19	-27.2 Milligrams per liter (mg/L) Standard Deviation 80.24
Change From Baseline in Urine Albumin Levels Visit 13 (Week 190); n= 10	-2.8 Milligrams per liter (mg/L) Standard Deviation 27.95
Change From Baseline in Urine Albumin Levels Visit 14 (Week 208); n= 8	-15.9 Milligrams per liter (mg/L) Standard Deviation 45.76
Change From Baseline in Urine Albumin Levels Visit 15 (Week 225); n= 4	-1.8 Milligrams per liter (mg/L) Standard Deviation 11.53
Change From Baseline in Urine Albumin Levels Visit 16 (Week 242); n= 3	-8.7 Milligrams per liter (mg/L) Standard Deviation 9.61
Change From Baseline in Urine Albumin Levels Visit 17 (Week 260); n= 3	-3.3 Milligrams per liter (mg/L) Standard Deviation 12.86
Change From Baseline in Urine Albumin Levels Visit 18 (Week 277); n= 2	-7.5 Milligrams per liter (mg/L) Standard Deviation 0.71
Change From Baseline in Urine Albumin Levels Withdrawal visit; n= 63	-6.5 Milligrams per liter (mg/L) Standard Deviation 51.69
Change From Baseline in Urine Albumin Levels Follow up visit; n= 48	-19.9 Milligrams per liter (mg/L) Standard Deviation 99.24

PRIMARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

Urine samples were collected from participants for evaluation of change from Baseline in urinalysis parameters including creatinine levels. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Change From Baseline in Urine Creatinine Levels Visit 13 (Week 190); n= 19	-3604.1 µmol/L Standard Deviation 10215.20
Change From Baseline in Urine Creatinine Levels Visit 14 (Week 208); n= 10	3238.3 µmol/L Standard Deviation 12290.24
Change From Baseline in Urine Creatinine Levels Visit 15 (Week 225); n= 5	-675.0 µmol/L Standard Deviation 16785.90
Change From Baseline in Urine Creatinine Levels Visit 16 (Week 242); n= 4	-5426.3 µmol/L Standard Deviation 13280.49
Change From Baseline in Urine Creatinine Levels Visit 17 (Week 260); n= 4	148.8 µmol/L Standard Deviation 15164.36
Change From Baseline in Urine Creatinine Levels Visit 18 (Week 277); n= 2	-7337.5 µmol/L Standard Deviation 10850.55
Change From Baseline in Urine Creatinine Levels Withdrawal visit; n= 80	-3570.3 µmol/L Standard Deviation 8244.65
Change From Baseline in Urine Creatinine Levels Follow up visit; n= 60	-515.8 µmol/L Standard Deviation 9359.74
Change From Baseline in Urine Creatinine Levels Visit 1 (Screening); n= 52	-2019.6 µmol/L Standard Deviation 10153.70
Change From Baseline in Urine Creatinine Levels Visit 2 (Week 13); n= 89	-1846.2 µmol/L Standard Deviation 8206.65
Change From Baseline in Urine Creatinine Levels Visit 3 (Week 26); n= 75	-3023.7 µmol/L Standard Deviation 9197.50
Change From Baseline in Urine Creatinine Levels Visit 4 (Week 39); n= 66	-2849.6 µmol/L Standard Deviation 7810.79
Change From Baseline in Urine Creatinine Levels Visit 5 (Week 52); n= 63	-1626.5 µmol/L Standard Deviation 10205.13
Change From Baseline in Urine Creatinine Levels Visit 6 (Week 69); n= 59	-3534.2 µmol/L Standard Deviation 8657.09
Change From Baseline in Urine Creatinine Levels Visit 7 (Week 86); n= 55	-2664.4 µmol/L Standard Deviation 7900.30
Change From Baseline in Urine Creatinine Levels Visit 8 (Week 104); n= 42	-2645.1 µmol/L Standard Deviation 8368.43
Change From Baseline in Urine Creatinine Levels Visit 9 (Week 121); n= 37	-1727.3 µmol/L Standard Deviation 10330.75
Change From Baseline in Urine Creatinine Levels Visit 10 (Week 138); n= 35	-1712.6 µmol/L Standard Deviation 11352.03
Change From Baseline in Urine Creatinine Levels Visit 11 (Week 156); n= 30	-1400.0 µmol/L Standard Deviation 13151.92
Change From Baseline in Urine Creatinine Levels Visit 12 (Week 173); n= 23	-1008.3 µmol/L Standard Deviation 9395.56

PRIMARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

The effect of retigabine on bladder function was assessed using AUA symptom index. It is a 7-item Likert-scored scale ranging from 0 (no symptom at all) to 5 (almost always symptoms present) with a total possible score of 35. AUA SS score is the sum of the responses to these seven questions. The total score for all questions was classified as mild (0 to 7), moderate (8 to 19), or severe (\>19). Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Changes From Baseline in American Urological Association Symptom Scale (AUA SS) Score Visit 3 (Week 26); n= 82	-0.7 Score on AUA SS scale Standard Deviation 3.50
Changes From Baseline in American Urological Association Symptom Scale (AUA SS) Score Visit 5 (Week 52); n= 68	-0.9 Score on AUA SS scale Standard Deviation 4.67
Changes From Baseline in American Urological Association Symptom Scale (AUA SS) Score Visit 8 (Week 104); n= 42	-1.0 Score on AUA SS scale Standard Deviation 3.79
Changes From Baseline in American Urological Association Symptom Scale (AUA SS) Score Visit 11 (Week 156); n= 31	-1.0 Score on AUA SS scale Standard Deviation 4.18
Changes From Baseline in American Urological Association Symptom Scale (AUA SS) Score Visit 14 (Week 208); n= 10	-2.3 Score on AUA SS scale Standard Deviation 5.54
Changes From Baseline in American Urological Association Symptom Scale (AUA SS) Score Visit 17 (Week 260); n= 4	-6.5 Score on AUA SS scale Standard Deviation 7.72
Changes From Baseline in American Urological Association Symptom Scale (AUA SS) Score Withdrawal visit; n= 85	-1.0 Score on AUA SS scale Standard Deviation 3.99

PRIMARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

The PVR bladder ultrasound was used to assess urinary retention. Baseline was defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Urine Volume Visit 3 (Week 26); n= 77	-6.0 Milliliter (mL) Standard Deviation 24.73
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Urine Volume Visit 5 (Week 52); n= 64	2.7 Milliliter (mL) Standard Deviation 49.20
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Urine Volume Visit 8 (Week 104); n= 40	3.9 Milliliter (mL) Standard Deviation 49.03
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Urine Volume Visit 11 (Week 156); n= 25	2.0 Milliliter (mL) Standard Deviation 18.40
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Urine Volume Visit 14 (Week 208); n= 10	-16.0 Milliliter (mL) Standard Deviation 21.33
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Urine Volume Visit 17 (Week 260); n= 4	-23.3 Milliliter (mL) Standard Deviation 25.00
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Urine Volume Withdrawal visit; n= 67	-7.6 Milliliter (mL) Standard Deviation 30.39

PRIMARY outcome

Timeframe: Up to 5.8 years

Population: Safety Population

Number of participants with suicidal ideation or behavior during treatment were assessed using the C-SSRS score scale. It is a brief questionnaire designed to assess severity and change in suicidality by integrating both behavior and ideation using a semi-structured interview to probe participant responses. Participants are classified with respect to extent of suicidal ideation, extent of suicidal behavior, and with respect to self-injurious behavior.

Outcome measures

Outcome measures
Measure	Retigabine IR n=95 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants With Suicidal Ideation or Behavior Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score Suicidal ideation	1 Participants
Number of Participants With Suicidal Ideation or Behavior Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score Suicidal behavior	0 Participants
Number of Participants With Suicidal Ideation or Behavior Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score Self-injurious behavior, no suicidal attempt	0 Participants

PRIMARY outcome

Timeframe: Up to 5.8 years

Population: Safety Population

Number of participants experiencing new seizure type that is seizure not experienced before were summarized. New seizure types were classified into 5 classes including type A (simple partial seizure), type B (complex partial seizure), type C (Partials, evolving to Secondary Generalized Seizures), type D (Generalized, excluding Myoclonic Seizures), type D2 (Myoclonic Seizures) and type E (Unclassified Seizures).

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants Experiencing New Seizure Types Type A; Simple Partial Seizures	5 Participants
Number of Participants Experiencing New Seizure Types Type B; Complex Partial Seizures	2 Participants
Number of Participants Experiencing New Seizure Types Type C; Partials, evolving to Sec. Gen. Seizures	0 Participants
Number of Participants Experiencing New Seizure Types Type D; Generalized, excl. Myoclonic Seizures	0 Participants
Number of Participants Experiencing New Seizure Types Type D2; Myoclonic Seizures	0 Participants
Number of Participants Experiencing New Seizure Types Type E; Unclassified seizures	0 Participants

PRIMARY outcome

Timeframe: Up to 5.8 years

Population: Safety Population

Worsening of seizures was defined as an increase in seizure frequency or the occurrence of a new, more severe seizure type, or status epilepticus occurring in a participant without a history of status epilepticus. An increase in seizure frequency was defined as doubling of the 28-day seizure frequency compared to the 28-day Baseline seizure frequency established in the parent study. Number of participants experiencing worsening of seizure during study period are presented.

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants Experiencing Worsening of Seizures	1 Participants

PRIMARY outcome

Timeframe: Up to 5.8 years

Population: Safety Population

Duration of exposure was calculated from the first dose through the last dose during study including the Taper Phase and presented using median and full range.

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Duration of Retigabine Exposure	103.7 Weeks Interval 0.5 to 284.0

PRIMARY outcome

Timeframe: Up to 2.6 years

Population: All SFUCP Subjects

The ophthalmologist/retina specialist determined the presence or absence of retinal and non-retinal ocular abnormalities. Retinal abnormalities included abnormalities in the macula and/or the peripheral retina and non-retinal ocular pigmentary abnormality.

Outcome measures

Outcome measures
Measure	Retigabine IR n=9 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine Retinal pigmentary abnormality	1 Participants
Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine Non-retinal ocular pigmentary abnormality	1 Participants

PRIMARY outcome

Timeframe: Up to 2.6 years

Population: All SFUCP Subjects

Participants who enter the SFUCP who had an on-treatment finding(s) of abnormal discoloration of skin, lips, nails or mucosa confirmed by a dermatologist entered the SFUCP and underwent assessments performed by a dermatologist at 6-monthly intervals. The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa.

Outcome measures

Outcome measures
Measure	Retigabine IR n=9 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine	2 Participants

PRIMARY outcome

Timeframe: Up to 2.6 years

Population: All SFUCP Subjects

Retinal pigmentary abnormality was determined by either an ophthalmologist or retina specialist. Retinal pigmentary abnormality included abnormality of macula, peripheral retina and unspecified location. If a participant had pigmentary abnormality of macula and pigmentary abnormality of the peripheral retina both should be resolved in order for retinal pigmentary abnormality to be considered resolved. If a participant had non-retinal ocular pigmentary abnormality in more than one location (conjunctiva, sclera, cornea, iris or lens), all should be resolved for non-retinal pigmentary abnormality to be considered resolved.

Outcome measures

Outcome measures
Measure	Retigabine IR n=1 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation Retinal Pigmentary Abnormality	157.0 Days Interval 157.0 to 157.0
Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation Non-Retinal Ocular Pigmentary Abnormality	119.0 Days Interval 119.0 to 119.0

PRIMARY outcome

Timeframe: Up to 2.6 years

Population: All SFUCP Subjects

Assessments were at approximately 6-monthly intervals (timed relative to the participants previous dermatology assessment) until the abnormal discoloration either resolved or stabilized (as defined by no changes over 2 consecutive 6-monthly assessments performed by the dermatologist over at least 12 months after discontinuation of retigabine). The assessment of the participant's skin included assessment of the skin around the eyes and the eyelids, lips, nails, and mucosa. Only participants with resolution of the specified tissue are included in this analysis.

Outcome measures

Outcome measures
Measure	Retigabine IR n=9 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Time From Discontinuation of Retigabine to Resolution of All Dermatologist-confirmed Abnormal Discoloration Skin; n= 1	192.0 Days Interval 192.0 to 192.0
Time From Discontinuation of Retigabine to Resolution of All Dermatologist-confirmed Abnormal Discoloration All; n= 2	582.0 Days Interval 253.0 to 911.0
Time From Discontinuation of Retigabine to Resolution of All Dermatologist-confirmed Abnormal Discoloration Nails; n= 1	253.0 Days Interval 253.0 to 253.0
Time From Discontinuation of Retigabine to Resolution of All Dermatologist-confirmed Abnormal Discoloration Mucosa; n= 3	701.0 Days Interval 192.0 to 911.0

SECONDARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

The seizure frequency was recorded in daily seizure calendar by participants during the treatment period. Baseline assessments in this OLE study are defined by and taken directly from the Baseline assessments in the parent study NCT01336621.

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants Experiencing a 0 to <25, 25 to <50, 50 to <75 and 75 to 100 Percent Reduction in 28 Day POS Frequency From Baseline 0 to <25 percent reduction	7 Participants
Number of Participants Experiencing a 0 to <25, 25 to <50, 50 to <75 and 75 to 100 Percent Reduction in 28 Day POS Frequency From Baseline 25 to <50 percent reduction	13 Participants
Number of Participants Experiencing a 0 to <25, 25 to <50, 50 to <75 and 75 to 100 Percent Reduction in 28 Day POS Frequency From Baseline 50 to <75 percent reduction	26 Participants
Number of Participants Experiencing a 0 to <25, 25 to <50, 50 to <75 and 75 to 100 Percent Reduction in 28 Day POS Frequency From Baseline 75 to 100 percent reduction	42 Participants

SECONDARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

The seizure frequency was recorded in daily seizure calendar by participants during the treatment period. Percent change from Baseline in 28-day partial onset seizure frequency was presented as mean and standard deviation (SD). Baseline assessments in this OLE study are defined by and taken directly from the Baseline assessments in the parent study NCT01336621. Percent change from Baseline was calculated as post-Baseline value minus Baseline value divided by Baseline value into 100.

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Percent Change From Baseline in 28-day Partial-onset Seizure Frequency	-56.9 Percent change Standard Deviation 52.46

SECONDARY outcome

Timeframe: Baseline and up to 5.8 years

Population: Safety Population

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants Experiencing an Increase in 28-day Partial-onset Seizure Frequency From Baseline	10 Participants

SECONDARY outcome

Timeframe: Up to 5.8 years

Population: Safety population

The seizure frequency was recorded in daily seizure calendar by participants during the treatment period. Number of participants who were treated retigabine for at least 6 months and who remained seizure free for any 6 continuous months as well as number of participants who were treated with retigabine for at least 12 months and who remained seizure free for any 12 continuous months are presented.

Outcome measures

Outcome measures
Measure	Retigabine IR n=98 Participants Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).
Number of Participants Who Remained Seizure-free Seizure free for 6 months; n= 85	27 Participants
Number of Participants Who Remained Seizure-free Seizure free for 12 months; n= 71	13 Participants

Adverse Events

Retigabine IR

Serious events: 4 serious events

Other events: 38 other events

Deaths: 0 deaths

Retigabine IR in SFUCP

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Retigabine IR n=98 participants at risk Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).	Retigabine IR in SFUCP n=9 participants at risk Participants who withdrew from the Open-Label Treatment Phase and who had retinal pigmentation or unexplained vision loss, pigmentation of non-retinal ocular tissue or abnormal discoloration of nails, lips, skin or mucosa were followed-up in SFUCP following discontinuation of their retigabine, which was the final reporting phase of the study. During SFUCP, participants underwent six monthly comprehensive eye examinations and/or dermatological assessments. Participants were followed-up until the discoloration /pigmentation either resolves or stabilizes, as defined by no change over two consecutive six monthly assessments over at least 12 months after discontinuation of RTG IR .
Nervous system disorders Cerebrovascular disorder	1.0% 1/98 • Number of events 2 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	0.00% 0/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Nervous system disorders Generalised tonic-clonic seizure	1.0% 1/98 • Number of events 1 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	0.00% 0/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Nervous system disorders Seizure	1.0% 1/98 • Number of events 1 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	0.00% 0/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Psychiatric disorders Agitation	1.0% 1/98 • Number of events 1 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	0.00% 0/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Psychiatric disorders Epileptic psychosis	1.0% 1/98 • Number of events 1 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	0.00% 0/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Injury, poisoning and procedural complications Scar	1.0% 1/98 • Number of events 1 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	0.00% 0/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Investigations Hemoglobin decreased	1.0% 1/98 • Number of events 1 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	0.00% 0/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma stage II	1.0% 1/98 • Number of events 1 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	0.00% 0/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/98 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	11.1% 1/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Retigabine IR n=98 participants at risk Eligible participants continued on the same maintenance dose of retigabine IR and the concurrent anti-epileptic drugs (AEDs) as they were taking at Visit 7 (Week 20) in the parent study NCT01336621. After the first week of the study, the dose of retigabine IR could be increased or decreased by 50-150 milligrams per day (mg/day) on a weekly basis. The overall daily dose of retigabine IR was to be maintained between 300 mg/day (minimum) and 1200 mg/day (maximum).	Retigabine IR in SFUCP n=9 participants at risk Participants who withdrew from the Open-Label Treatment Phase and who had retinal pigmentation or unexplained vision loss, pigmentation of non-retinal ocular tissue or abnormal discoloration of nails, lips, skin or mucosa were followed-up in SFUCP following discontinuation of their retigabine, which was the final reporting phase of the study. During SFUCP, participants underwent six monthly comprehensive eye examinations and/or dermatological assessments. Participants were followed-up until the discoloration /pigmentation either resolves or stabilizes, as defined by no change over two consecutive six monthly assessments over at least 12 months after discontinuation of RTG IR .
Respiratory, thoracic and mediastinal disorders Respiratory disorder	6.1% 6/98 • Number of events 7 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	0.00% 0/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Nervous system disorders Dizziness	14.3% 14/98 • Number of events 18 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	0.00% 0/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Nervous system disorders Headache	10.2% 10/98 • Number of events 23 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	0.00% 0/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
General disorders Asthenia	11.2% 11/98 • Number of events 20 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	0.00% 0/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Investigations Weight increased	7.1% 7/98 • Number of events 7 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	0.00% 0/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Infections and infestations Bacteriuria	6.1% 6/98 • Number of events 7 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	0.00% 0/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Skin and subcutaneous tissue disorders Nail pigmentation	6.1% 6/98 • Number of events 6 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	0.00% 0/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast fibroma	0.00% 0/98 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	11.1% 1/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Eye disorders Iridocyclitis	0.00% 0/98 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	11.1% 1/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Gastrointestinal disorders Haemorrhoids	0.00% 0/98 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	11.1% 1/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Gastrointestinal disorders Oral mucosal discolouration	0.00% 0/98 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	11.1% 1/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Infections and infestations Urinary tract infection	0.00% 0/98 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	11.1% 1/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/98 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	11.1% 1/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Reproductive system and breast disorders Amenorrhoea	0.00% 0/98 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	11.1% 1/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/98 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.	11.1% 1/9 • Treatment emergent Serious adverse events (TESAEs) and non-serious adverse events (TEAEs) were collected from the start of the study treatment until the end-of study treatment (Up to 5.8 years). AEs and SAEs were collected in 'Safety Population' for retigabine IR arm and in 'All SFUCP subjects Population' for Retigabine IR in SFUCP arm. The MedDRA version for the Primary Reporting Phase is 19.1. However the SFUCP phase uses version 20.1.