Trial Outcomes & Findings for Open-Label Extension Study of the Phase 3 VRX-RET-E22-302 Double-Blind Trial. 115097 (NCT NCT00310388)

Last Updated: 2018-11-15

Results Overview

An AE is defined as 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/incapacity, is a congenital anomaly/birth defect, other situations and is associated with impaired liver function. TEAEs refer to an AE for which the onset was on or after 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 worsened in this study were also considered as TEAEs. Analysis was performed on the safety population which included participants who took at least 1 dose of study medication after being enrolled in this OLE study.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

376 participants

Primary outcome timeframe

Up to 122 months

Results posted on

2018-11-15

Participant Flow

This was a multi-center, open-label, long-term, safety, tolerability and efficacy study involving 57 study sites in 13 countries (Australia, Belgium, France, Germany, Hungary, Israel, Poland, Russia, South Africa, Spain, Ukraine, the United Kingdom and the United States).

A total of 376 adult epilepsy participants with partial-onset seizures who completed the parent study (VRX-RET-E22-302 \[NCT00235755\]) entered this open label extension (OLE) study.

Participant milestones

Participant milestones
Measure	Retigabine Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 milligrams (mg) three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing antiepileptic drugs (AEDs) with or without vagal nerve stimulation (VNS) up to 121 months.	Safety Follow-up Continuation Phase (SFUCP) Participants who withdraw from retigabine and who had retinal pigmentation or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of nails, lips, skin or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
Primary Reporting Phase STARTED	376	0
Primary Reporting Phase COMPLETED	30	0
Primary Reporting Phase NOT COMPLETED	346	0
Safety Follow-up Continuation Phase STARTED	0	26
Safety Follow-up Continuation Phase COMPLETED	0	13
Safety Follow-up Continuation Phase NOT COMPLETED	0	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Retigabine Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 milligrams (mg) three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing antiepileptic drugs (AEDs) with or without vagal nerve stimulation (VNS) up to 121 months.	Safety Follow-up Continuation Phase (SFUCP) Participants who withdraw from retigabine and who had retinal pigmentation or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of nails, lips, skin or mucosa entered the SFUCP. During the SFUCP, participants underwent 6-monthly comprehensive eye examinations and/or skin assessments by the investigator, ophthalmologist, retinal specialist or dermatologist as appropriate. Participants were followed up in the SFUCP until the dermatology/ophthalmology finding(s) either resolved or stabilized. Stabilization was defined in the protocol as no changes on two consecutive 6-monthly assessments over at least over 12 months after discontinuation of retigabine.
Primary Reporting Phase Adverse Event	101	0
Primary Reporting Phase Lack of Efficacy	56	0
Primary Reporting Phase Withdrawal by Subject	97	0
Primary Reporting Phase Protocol Violation	10	0
Primary Reporting Phase Pregnancy	3	0
Primary Reporting Phase Change in participant medical condition	3	0
Primary Reporting Phase Persistent ALT/AST above 3 times the ULN	3	0
Primary Reporting Phase ALT/AST levels above 5 times the ULN	3	0
Primary Reporting Phase Physician Decision	2	0
Primary Reporting Phase Request of the sponsor	19	0
Primary Reporting Phase Failed to return	8	0
Primary Reporting Phase Participant request unrelated to study	2	0
Primary Reporting Phase Participant request	2	0
Primary Reporting Phase Ministry of Health decision	25	0
Primary Reporting Phase Discontinuation of study	1	0
Primary Reporting Phase Participant Immigrated to New Zealand	1	0
Primary Reporting Phase Termination of study at sponsor request	3	0
Primary Reporting Phase Ongoing SAE from parent study	1	0
Primary Reporting Phase Due to pigmentation risk concerns	2	0
Primary Reporting Phase Participant passed away	1	0
Primary Reporting Phase Participant retired the informed consent	1	0
Primary Reporting Phase Missing	1	0
Primary Reporting Phase Other	1	0
Safety Follow-up Continuation Phase Missing SFUCP disposition information	0	5
Safety Follow-up Continuation Phase Adverse Event	0	1
Safety Follow-up Continuation Phase Withdrawal by Subject	0	5
Safety Follow-up Continuation Phase Study Closed/Terminated	0	2

Baseline Characteristics

Open-Label Extension Study of the Phase 3 VRX-RET-E22-302 Double-Blind Trial. 115097

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Age, Continuous	37.0 years STANDARD_DEVIATION 11.85 • n=5 Participants
Sex: Female, Male Female	195 Participants n=5 Participants
Sex: Female, Male Male	181 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	360 Participants n=5 Participants
Race/Ethnicity, Customized African-American (Black)	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 122 months

Population: Safety Population

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) Any TEAE	324 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) Any TESAE	78 Participants

PRIMARY outcome

Timeframe: Up to 122 months

Population: Safety Population

An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A summary of participants with treatment emergent AEs leading to treatment disc. up to 122 months have been presented.

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Number of Participants With TEAEs Leading to Treatment Discontinuation (Disc.)	115 Participants

PRIMARY outcome

Timeframe: Up to 122 months

Population: Safety Population

Kaplan-Meier estimate of the probability of disc. at the specified time for all participants is presented. The time frame of premature study disc. was defined as the time from the day of first the study medication to the time of withdrawal from study drug. For those who had a taper dose start date, the time of withdrawal was the day before the start of taper dose. Participants who switched to commercial product were censored at the last dose of study drug (excluding taper). All participants who withdrew from the study/treatment prematurely but did not switch to commercial product were counted as an event. Number of participants continuing on retigabine at each time of withdrawal were analyzed (represented by n=x in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 118, n=302	19.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 121, n=300	20.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2, n=369	1.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 3, n=368	2.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 4, n=367	2.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 41, n=339	9.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 42, n=338	10.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 92, n=313	16.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 94, n=312	17.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 95, n=310	17.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 104, n=308	18.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 105, n=307	18.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 107, n=306	18.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 110, n=305	18.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 184, n=271	27.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 189, n=268	28.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 192, n=267	29.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 195, n=265	29.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 218, n=259	31.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 221, n=258	31.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 228, n=257	31.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 231, n=256	31.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 264, n=248	34.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 265, n=247	34.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 269, n=246	34.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 270, n=245	34.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 278, n=235	37.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 279, n=234	37.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 292, n=233	38.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 299, n=231	38.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 301, n=230	38.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 322, n=225	40.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 358, n=219	41.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 478, n=204	45.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 587, n=184	51.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 596, n=181	51.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 700, n=167	55.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 719, n=161	57.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 720, n=160	57.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 760, n=156	58.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 781, n=151	59.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 841, n=144	61.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 927, n=132	64.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1141, n=117	68.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1206, n=112	70.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1207, n=111	70.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1221, n=109	71.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1436, n=102	72.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1569, n=91	74.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1849, n=68	76.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1855, n=67	76.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1920, n=62	77.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1926, n=61	77.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1931, n=58	78.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1937, n=57	78.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2161, n=50	80.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2400, n=36	85.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2639, n=28	88.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 3246, n=8	96.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 3582, n=1	99.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 0, n=374	0.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1, n=371	1.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 5, n=366	2.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 6, n=365	2.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 11, n=364	3.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 13, n=363	3.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 14, n=362	3.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 16, n=361	4.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 21, n=360	4.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 22, n=359	4.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 27, n=356	5.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 28, n=350	6.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 29, n=348	7.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 30, n=344	8.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 32, n=343	8.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 35, n=341	9.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 40, n=340	9.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 45, n=337	10.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 50, n=336	10.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 56, n=335	10.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 61, n=334	11.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 62, n=333	11.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 63, n=331	12.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 71, n=330	12.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 77, n=329	12.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 82, n=328	12.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 85, n=326	13.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 86, n=325	13.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 88, n=324	13.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 90, n=322	14.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 91, n=316	16.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 99, n=309	17.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 112, n=303	19.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 122, n=299	20.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 126, n=298	20.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 132, n=297	21.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 134, n=296	21.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 135, n=295	21.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 138, n=294	21.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 139, n=293	22.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 141, n=292	22.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 152, n=291	22.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 155, n=290	22.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 161, n=289	23.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 164, n=288	23.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 172, n=287	23.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 176, n=286	23.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 179, n=282	25.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 180, n=278	26.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 181, n=275	26.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 182, n=273	27.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 183, n=272	27.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 187, n=270	28.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 188, n=269	28.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 198, n=264	29.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 199, n=263	30.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 204, n=262	30.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 214, n=261	30.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 216, n=260	30.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 233, n=255	32.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 235, n=254	32.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 236, n=253	32.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 237, n=251	33.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 252, n=250	33.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 260, n=249	33.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 272, n=240	36.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 274, n=239	36.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 275, n=238	36.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 276, n=236	37.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 310, n=229	39.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 315, n=228	39.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 316, n=227	39.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 317, n=226	39.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 325, n=224	40.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 339, n=223	40.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 351, n=222	41.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 357, n=221	41.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 363, n=218	42.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 372, n=217	42.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 375, n=216	42.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 377, n=215	42.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 416, n=214	43.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 419, n=213	43.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 425, n=212	43.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 429, n=211	43.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 437, n=210	44.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 447, n=209	44.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 455, n=208	44.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 458, n=207	44.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 460, n=206	45.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 461, n=205	45.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 480, n=203	46.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 482, n=202	46.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 485, n=200	46.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 492, n=197	47.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 493, n=196	47.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 497, n=194	48.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 498, n=193	48.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 501, n=192	48.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 523, n=191	49.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 525, n=190	49.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 534, n=189	49.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 536, n=188	50.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 541, n=187	50.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 553, n=186	50.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 556, n=185	50.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 593, n=183	51.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 594, n=182	51.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 601, n=180	52.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 602, n=178	52.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 610, n=177	52.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 612, n=176	53.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 617, n=175	53.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 618, n=174	53.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 632, n=173	54.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 635, n=172	54.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 669, n=171	54.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 676, n=170	54.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 678, n=169	55.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 685, n=168	55.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 702, n=165	56.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 703, n=164	56.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 707, n=163	56.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 714, n=162	56.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 721, n=159	57.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 724, n=158	58.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 729, n=157	58.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 775, n=155	58.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 777, n=154	59.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 778, n=153	59.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 779, n=152	59.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 796, n=150	60.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 803, n=149	60.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 818, n=148	60.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 835, n=147	60.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 840, n=146	61.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 842, n=143	62.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 844, n=142	62.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 845, n=141	62.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 855, n=140	62.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 856, n=139	63.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 863, n=138	63.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 870, n=137	63.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 884, n=136	63.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 893, n=135	64.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 904, n=134	64.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 924, n=133	64.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 938, n=131	65.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 944, n=130	65.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 947, n=128	66.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 952, n=127	66.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 975, n=126	66.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 980, n=125	66.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 994, n=123	67.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1067, n=122	67.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1074, n=121	67.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1084, n=120	68.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1091, n=119	68.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1129, n=118	68.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1142, n=116	69.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1148, n=115	69.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1196, n=114	69.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1198, n=113	69.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1211, n=110	70.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1231, n=108	71.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1299, n=107	71.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1316, n=106	71.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1322, n=105	72.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1389, n=104	72.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1413, n=103	72.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1446, n=101	72.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1450, n=100	73.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1451, n=99	73.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1452, n=98	73.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1521, n=97	73.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1541, n=96	73.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1545, n=95	73.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1547, n=94	74.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1563, n=93	74.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1567, n=92	74.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1589, n=90	74.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1618, n=89	74.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1619, n=88	74.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1623, n=87	74.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1632, n=86	74.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1656, n=85	74.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1660, n=84	74.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1668, n=83	74.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1672, n=82	75.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1676, n=81	75.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1680, n=80	75.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1694, n=79	75.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1697, n=78	75.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1752, n=77	75.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1756, n=76	75.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1760, n=75	75.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1792, n=74	76.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1802, n=73	76.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1807, n=72	76.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1814, n=71	76.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1819, n=70	76.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1836, n=69	76.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1887, n=66	76.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1895, n=65	76.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1904, n=64	76.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1919, n=63	76.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1928, n=60	77.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1929, n=59	77.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 1951, n=56	78.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2005, n=55	79.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2037, n=54	79.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2044, n=53	79.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2092, n=52	79.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2157, n=51	80.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2162, n=49	81.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2182, n=48	81.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2183, n=47	81.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2184, n=46	82.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2227, n=45	82.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2281, n=44	82.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2283, n=43	83.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2285, n=42	83.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2296, n=41	83.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2317, n=40	84.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2380, n=39	84.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2395, n=37	85.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2405, n=35	86.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2408, n=34	86.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2415, n=33	86.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2443, n=32	86.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2525, n=31	87.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2533, n=30	87.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2537, n=29	88.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2664, n=27	88.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2772, n=26	89.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2793, n=25	89.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2829, n=24	90.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2870, n=23	90.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2884, n=22	91.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2973, n=21	91.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2975, n=20	91.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 2998, n=19	92.2 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 3101, n=18	92.6 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 3118, n=17	93.0 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 3137, n=16	93.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 3144, n=15	93.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 3147, n=14	94.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 3185, n=13	94.7 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 3220, n=11	95.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 3231, n=10	95.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 3243, n=9	96.3 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 3276, n=7	97.1 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 3277, n=6	97.5 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 3285, n=5	97.9 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 3318, n=4	98.4 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 3360, n=3	98.8 Percentage Probability of disc.
Kaplan-Meier Estimate of the Probability of Disc. From Study Drug Day 3483, n=2	99.2 Percentage Probability of disc.

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

Vital sign measurements (supine and standing blood pressure ) were obtained throughout the study at all visits during the Open-Label Treatment Phase of the study. Evaluations of blood pressure were performed supine at each study visit, and again after the participant had been standing for approximately 2 minutes. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 15 (Month 52), n=91	0.1 Millimeters of mercury Standard Deviation 11.10
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 28 (Month 104), n=17	3.4 Millimeters of mercury Standard Deviation 10.56
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 32 (Month 120), n=1	-2.0 Millimeters of mercury Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 7 (Month 20), n=181	0.4 Millimeters of mercury Standard Deviation 9.51
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 31 (Month 116), n=3	8.0 Millimeters of mercury Standard Deviation 11.79
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 24 (Month 88), n=29	2.7 Millimeters of mercury Standard Deviation 12.51
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 32 (Month 120), n=1	11.0 Millimeters of mercury Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 19 (Month 68), n=53	0.2 Millimeters of mercury Standard Deviation 11.85
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 30 (Month 112), n=4	1.8 Millimeters of mercury Standard Deviation 9.60
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 1 (Month 1), n=358	0.4 Millimeters of mercury Standard Deviation 10.05
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 2 (Month 3), n=328	0.3 Millimeters of mercury Standard Deviation 9.83
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 3 (Month 6), n=287	-0.2 Millimeters of mercury Standard Deviation 10.19
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 4 (Month 9), n=251	0.0 Millimeters of mercury Standard Deviation 11.09
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 5 (Month 12), n=235	0.7 Millimeters of mercury Standard Deviation 10.79
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 6 (Month 16), n=202	1.0 Millimeters of mercury Standard Deviation 10.02
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 7 (Month 20), n=181	0.4 Millimeters of mercury Standard Deviation 10.03
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 8 (Month 24), n=167	0.4 Millimeters of mercury Standard Deviation 10.63
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 9 (Month 28), n=147	1.5 Millimeters of mercury Standard Deviation 10.62
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 10 (Month 32), n=128	0.0 Millimeters of mercury Standard Deviation 10.42
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 11 (Month 36), n=121	1.0 Millimeters of mercury Standard Deviation 10.65
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP,Visit 12 (Month 40), n=112	2.0 Millimeters of mercury Standard Deviation 10.37
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 13 (Month 44), n=105	0.5 Millimeters of mercury Standard Deviation 9.54
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 14 (Month 48), n=104	0.0 Millimeters of mercury Standard Deviation 10.30
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 16 (Month 56), n=77	1.2 Millimeters of mercury Standard Deviation 9.68
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 17 (Month 60), n=92	-1.0 Millimeters of mercury Standard Deviation 11.08
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 18 (Month 64), n=58	1.6 Millimeters of mercury Standard Deviation 8.29
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 19 (Month 68), n=53	0.6 Millimeters of mercury Standard Deviation 8.66
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 20 (Month 72), n=61	1.3 Millimeters of mercury Standard Deviation 8.38
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 21 (Month 76), n=43	3.2 Millimeters of mercury Standard Deviation 8.88
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 22 (Month 80), n=37	1.8 Millimeters of mercury Standard Deviation 7.66
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 23 (Month 84), n=32	-1.4 Millimeters of mercury Standard Deviation 8.64
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 24 (Month 88), n=29	3.4 Millimeters of mercury Standard Deviation 8.83
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 25 (Month 92), n=25	2.3 Millimeters of mercury Standard Deviation 7.29
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 26 (Month 96), n=26	1.5 Millimeters of mercury Standard Deviation 10.10
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 27 (Month 100), n=20	1.5 Millimeters of mercury Standard Deviation 8.42
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 29 (Month 108), n=13	0.5 Millimeters of mercury Standard Deviation 6.74
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 30 (Month 112), n=4	4.0 Millimeters of mercury Standard Deviation 7.30
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Visit 31 (Month 116), n=3	11.0 Millimeters of mercury Standard Deviation 7.55
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine DBP, Follow up, n=267	1.3 Millimeters of mercury Standard Deviation 10.08
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 1 (Month 1), n=357	0.6 Millimeters of mercury Standard Deviation 10.68
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 2 (Month 3), n=328	0.2 Millimeters of mercury Standard Deviation 10.62
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 3 (Month 6), n=287	-0.1 Millimeters of mercury Standard Deviation 10.21
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 4 (Month 9), n=251	0.2 Millimeters of mercury Standard Deviation 10.14
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 5 (Month 12), n=235	0.8 Millimeters of mercury Standard Deviation 10.17
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 6 (Month 16), n=202	0.3 Millimeters of mercury Standard Deviation 10.16
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 8 (Month 24), n=167	0.2 Millimeters of mercury Standard Deviation 9.83
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 9 (Month 28), n=147	0.3 Millimeters of mercury Standard Deviation 10.00
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 10 (Month 32), n=128	-0.6 Millimeters of mercury Standard Deviation 10.64
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 11 (Month 36), n=121	0.9 Millimeters of mercury Standard Deviation 10.94
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 12 (Month 40), n=111	1.4 Millimeters of mercury Standard Deviation 11.01
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 13 (Month 44), n=105	-0.2 Millimeters of mercury Standard Deviation 10.76
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 14 (Month 48), n=104	0.3 Millimeters of mercury Standard Deviation 10.35
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 15 (Month 52), n=91	-1.5 Millimeters of mercury Standard Deviation 11.00
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 16 (Month 56), n=77	-0.3 Millimeters of mercury Standard Deviation 10.40
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 17 (Month 60), n=92	-1.5 Millimeters of mercury Standard Deviation 9.70
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 18 (Month 64), n=58	0.5 Millimeters of mercury Standard Deviation 8.07
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 19 (Month 68), n=53	0.0 Millimeters of mercury Standard Deviation 7.20
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 20 (Month 72), n=61	0.3 Millimeters of mercury Standard Deviation 8.31
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 21 (Month 76), n=43	1.4 Millimeters of mercury Standard Deviation 8.93
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 22 (Month 80), n=37	0.3 Millimeters of mercury Standard Deviation 8.03
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 23 (Month 84), n=32	-0.4 Millimeters of mercury Standard Deviation 7.98
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 24 (Month 88), n=29	1.6 Millimeters of mercury Standard Deviation 8.38
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 25 (Month 92), n=25	1.0 Millimeters of mercury Standard Deviation 7.33
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 26 (Month 96), n=26	1.6 Millimeters of mercury Standard Deviation 9.20
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 27 (Month 100), n=20	0.2 Millimeters of mercury Standard Deviation 10.48
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 28 (Month 104), n=17	2.8 Millimeters of mercury Standard Deviation 11.65
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 29 (Month 108), n=13	-0.5 Millimeters of mercury Standard Deviation 9.42
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 30 (Month 112), n=4	1.3 Millimeters of mercury Standard Deviation 9.18
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Visit 32 (Month 120), n=1	-1.0 Millimeters of mercury Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing DBP, Follow up, n=267	2.0 Millimeters of mercury Standard Deviation 10.57
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 1 (Month 1), n=358	-0.2 Millimeters of mercury Standard Deviation 12.03
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 2 (Month 3), n=328	-0.4 Millimeters of mercury Standard Deviation 12.09
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 3 (Month 6), n=287	0.5 Millimeters of mercury Standard Deviation 13.53
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 4 (Month 9), n=251	0.0 Millimeters of mercury Standard Deviation 15.32
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 5 (Month 12), n=235	0.5 Millimeters of mercury Standard Deviation 12.99
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 6 (Month 16), n=202	0.7 Millimeters of mercury Standard Deviation 14.39
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 7 (Month 20), n=181	-0.5 Millimeters of mercury Standard Deviation 14.34
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 8 (Month 24), n=167	-0.4 Millimeters of mercury Standard Deviation 14.11
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 9 (Month 28), n=147	0.2 Millimeters of mercury Standard Deviation 13.78
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 10 (Month 32), n=128	0.3 Millimeters of mercury Standard Deviation 13.60
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 11 (Month 36), n=121	0.2 Millimeters of mercury Standard Deviation 14.90
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 12 (Month 40), n=112	1.3 Millimeters of mercury Standard Deviation 13.90
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 13 (Month 44), n=105	0.1 Millimeters of mercury Standard Deviation 11.28
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 14 (Month 48), n=104	-1.1 Millimeters of mercury Standard Deviation 13.03
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 15 (Month 52), n=91	-0.7 Millimeters of mercury Standard Deviation 14.05
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 16 (Month 56), n=77	2.6 Millimeters of mercury Standard Deviation 13.41
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 17 (Month 60), n=92	-0.2 Millimeters of mercury Standard Deviation 14.48
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 18 (Month 64), n=58	1.8 Millimeters of mercury Standard Deviation 12.11
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 19 (Month 68), n=53	1.1 Millimeters of mercury Standard Deviation 13.00
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 20 (Month 72), n=61	2.5 Millimeters of mercury Standard Deviation 10.26
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 21 (Month 76), n=43	4.4 Millimeters of mercury Standard Deviation 15.51
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 22 (Month 80), n=37	2.3 Millimeters of mercury Standard Deviation 15.13
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 23 (Month 84), n=32	1.1 Millimeters of mercury Standard Deviation 13.90
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 25 (Month 92), n=25	2.8 Millimeters of mercury Standard Deviation 10.44
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 26 (Month 96), n=26	2.9 Millimeters of mercury Standard Deviation 14.66
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 27 (Month 100), n=20	2.6 Millimeters of mercury Standard Deviation 10.61
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 28 (Month 104), n=17	5.8 Millimeters of mercury Standard Deviation 10.91
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 29 (Month 108), n=13	-2.2 Millimeters of mercury Standard Deviation 8.68
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 30 (Month 112), n=4	8.5 Millimeters of mercury Standard Deviation 6.95
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Visit 31 (Month 116), n=3	13.7 Millimeters of mercury Standard Deviation 4.93
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Supine SBP, Follow up, n=267	1.2 Millimeters of mercury Standard Deviation 14.15
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 1 (Month 1), n=357	-1.2 Millimeters of mercury Standard Deviation 12.20
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 2 (Month 3), n=328	-0.7 Millimeters of mercury Standard Deviation 13.30
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 3 (Month 6), n=287	-0.2 Millimeters of mercury Standard Deviation 13.89
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 4 (Month 9), n=251	-0.7 Millimeters of mercury Standard Deviation 15.10
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 5 (Month 12), n=235	-0.7 Millimeters of mercury Standard Deviation 14.56
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 6 (Month 16), n=202	-0.3 Millimeters of mercury Standard Deviation 14.09
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 7 (Month 20), n=181	-0.8 Millimeters of mercury Standard Deviation 15.19
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 8 (Month 24), n=167	-0.5 Millimeters of mercury Standard Deviation 15.35
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 9 (Month 28), n=147	-0.3 Millimeters of mercury Standard Deviation 16.30
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 10 (Month 32), n=128	-0.1 Millimeters of mercury Standard Deviation 15.06
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 11 (Month 36), n=121	0.7 Millimeters of mercury Standard Deviation 15.51
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 12 (Month 40), n=111	2.7 Millimeters of mercury Standard Deviation 14.21
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 13 (Month 44), n=105	-1.3 Millimeters of mercury Standard Deviation 12.57
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 14 (Month 48), n=104	-1.6 Millimeters of mercury Standard Deviation 14.67
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 15 (Month 52), n=91	-1.2 Millimeters of mercury Standard Deviation 14.35
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 16 (Month 56), n=77	0.9 Millimeters of mercury Standard Deviation 15.04
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 17 (Month 60), n=92	-0.7 Millimeters of mercury Standard Deviation 14.92
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 18 (Month 64), n= 58	0.6 Millimeters of mercury Standard Deviation 12.84
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 20 (Month 72), n=61	0.5 Millimeters of mercury Standard Deviation 12.43
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 21 (Month 76), n=43	3.5 Millimeters of mercury Standard Deviation 12.47
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 22 (Month 80), n=37	0.9 Millimeters of mercury Standard Deviation 14.31
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 23 (Month 84), n=32	-0.8 Millimeters of mercury Standard Deviation 14.85
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 24 (Month 88), n=29	-0.6 Millimeters of mercury Standard Deviation 13.28
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 25 (Month 92), n=25	-1.6 Millimeters of mercury Standard Deviation 10.49
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 26 (Month 96), n=26	-0.2 Millimeters of mercury Standard Deviation 14.68
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 27 (Month 100), n=20	0.0 Millimeters of mercury Standard Deviation 12.62
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 28 (Month 104), n=17	2.9 Millimeters of mercury Standard Deviation 11.70
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 29 (Month 108), n=13	-2.2 Millimeters of mercury Standard Deviation 10.58
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 31 (Month 116), n=3	9.0 Millimeters of mercury Standard Deviation 1.00
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Visit 32 (Month 120), n=1	10.0 Millimeters of mercury Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Measurements in the Supine and Standing Position Standing SBP, Follow up, n=267	1.4 Millimeters of mercury Standard Deviation 14.59

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

Vital sign measurement HR was obtained throughout the study at all visits during the Open-Label Treatment Phase of the study. Evaluations of HR was performed supine at each study visit, and again after the participant had been standing for approximately 2 minutes. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 7 (Month 20), n=181	1.4 Beats per minute Standard Deviation 12.71
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 1 (Month 1), n=358	-0.4 Beats per minute Standard Deviation 9.89
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 2 (Month 3), n=328	-0.5 Beats per minute Standard Deviation 9.93
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 3 (Month 6), n=287	0.1 Beats per minute Standard Deviation 9.62
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 4 (Month 9), n=252	0.7 Beats per minute Standard Deviation 9.69
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 5 (Month 12), n=235	0.0 Beats per minute Standard Deviation 9.83
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 6 (Month 16), n=202	1.8 Beats per minute Standard Deviation 10.56
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 7 (Month 20), n=181	2.3 Beats per minute Standard Deviation 11.87
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 8 (Month 24), n=167	1.9 Beats per minute Standard Deviation 10.28
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 9 (Month 28), n=147	2.7 Beats per minute Standard Deviation 10.86
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 10 (Month 32), n=128	3.0 Beats per minute Standard Deviation 10.50
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 11 (Month 36), n=121	0.8 Beats per minute Standard Deviation 10.33
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 12 (Month 40), n=112	3.3 Beats per minute Standard Deviation 11.20
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 13 (Month 44), n=105	1.8 Beats per minute Standard Deviation 10.59
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 14 (Month 48), n=104	1.0 Beats per minute Standard Deviation 10.78
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 15 (Month 52), n=91	2.0 Beats per minute Standard Deviation 12.20
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 16 (Month 56), n=77	2.5 Beats per minute Standard Deviation 10.70
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 17 (Month 60), n=92	0.9 Beats per minute Standard Deviation 12.25
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 18 (Month 64), n=58	5.5 Beats per minute Standard Deviation 10.44
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 19 (Month 68), n=53	2.4 Beats per minute Standard Deviation 10.19
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 20 (Month 72), n=61	2.1 Beats per minute Standard Deviation 12.23
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 21 (Month 76), n=43	2.8 Beats per minute Standard Deviation 9.30
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 22 (Month 80), n=37	5.1 Beats per minute Standard Deviation 10.13
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 23 (Month 84), n=32	3.5 Beats per minute Standard Deviation 11.98
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 24 (Month 88), n=29	3.2 Beats per minute Standard Deviation 13.66
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 25 (Month 92), n=25	3.9 Beats per minute Standard Deviation 9.89
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 26 (Month 96), n=26	2.1 Beats per minute Standard Deviation 10.37
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 27 (Month 100), n=20	3.1 Beats per minute Standard Deviation 9.82
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 28 (Month 104), n=17	3.3 Beats per minute Standard Deviation 8.62
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 29 (Month 108), n=13	0.5 Beats per minute Standard Deviation 8.93
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 30 (Month 112), n=4	3.8 Beats per minute Standard Deviation 12.84
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 31 (Month 116), n=3	7.7 Beats per minute Standard Deviation 13.43
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Visit 32 (Month 120), n=1	11.0 Beats per minute Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Supine HR, Follow up, n=267	2.1 Beats per minute Standard Deviation 10.44
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 1 (Month 1), n=357	-0.1 Beats per minute Standard Deviation 11.10
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 2 (Month 3), n=328	-0.2 Beats per minute Standard Deviation 11.01
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 3 (Month 6), n=287	0.3 Beats per minute Standard Deviation 10.39
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 4 (Month 9), n=252	1.7 Beats per minute Standard Deviation 11.53
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 5 (Month 12), n=235	0.1 Beats per minute Standard Deviation 11.06
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 6 (Month 16), n=202	1.6 Beats per minute Standard Deviation 12.35
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 8 (Month 24), n=167	1.9 Beats per minute Standard Deviation 10.93
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 9 (Month 28), n=147	1.6 Beats per minute Standard Deviation 11.25
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 10 (Month 32), n=128	2.2 Beats per minute Standard Deviation 11.92
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 11 (Month 36), n=121	-0.6 Beats per minute Standard Deviation 11.23
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 12 (Month 40), n=111	2.6 Beats per minute Standard Deviation 12.94
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 13 (Month 44), n=105	2.8 Beats per minute Standard Deviation 11.22
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 14 (Month 48), n=104	0.8 Beats per minute Standard Deviation 11.81
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 15 (Month 52), n=91	3.1 Beats per minute Standard Deviation 12.09
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 16 (Month 56), n=77	1.3 Beats per minute Standard Deviation 12.12
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 17 (Month 60), n=92	0.6 Beats per minute Standard Deviation 12.26
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 18 (Month 64), n=58	4.6 Beats per minute Standard Deviation 12.09
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 19 (Month 68), n=52	1.3 Beats per minute Standard Deviation 10.78
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 20 (Month 72), n=61	0.7 Beats per minute Standard Deviation 13.45
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 21 (Month 76), n=43	0.3 Beats per minute Standard Deviation 10.83
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 22 (Month 80), n=37	2.9 Beats per minute Standard Deviation 10.96
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 23 (Month 84), n=32	2.3 Beats per minute Standard Deviation 9.76
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 24 (Month 88), n=29	2.4 Beats per minute Standard Deviation 10.64
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 25 (Month 92), n=25	3.6 Beats per minute Standard Deviation 12.61
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 26 (Month 96), n=26	3.1 Beats per minute Standard Deviation 12.01
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 27 (Month 100), n=20	5.2 Beats per minute Standard Deviation 9.88
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Syanding HR, Visit 28 (Month 104), n=17	6.2 Beats per minute Standard Deviation 11.00
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 29 (Month 108), n=13	-0.2 Beats per minute Standard Deviation 8.94
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 30 (Month 112), n=4	2.3 Beats per minute Standard Deviation 12.84
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 31 (Month 116), n=3	7.3 Beats per minute Standard Deviation 12.10
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Visit 32 (Month 120), n=1	10.0 Beats per minute Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed
Change From Baseline in Heart Rate (HR) Measurements in the Supine and Standing Position Standing HR, Follow up, n=267	2.2 Beats per minute Standard Deviation 11.39

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

Vital sign measurement temperature was obtained throughout the study at all visits during the Open-Label Treatment Phase of the study. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Change From Baseline in Body Temperature Body temperature, Visit 14 (Month 48), n=100	0.05 Degree Celsius Standard Deviation 0.382
Change From Baseline in Body Temperature Body temperature, Visit 25 (Month 92), n=25	0.00 Degree Celsius Standard Deviation 0.289
Change From Baseline in Body Temperature Body temperature, Visit 26 (Month 96), n=26	-0.10 Degree Celsius Standard Deviation 0.299
Change From Baseline in Body Temperature Body temperature, Visit 27 (Month 100), n=20	-0.03 Degree Celsius Standard Deviation 0.285
Change From Baseline in Body Temperature Body temperature, Visit 28 (Month 104), n=17	-0.02 Degree Celsius Standard Deviation 0.326
Change From Baseline in Body Temperature Body temperature, Visit 29 (Month 108), n=13	0.04 Degree Celsius Standard Deviation 0.275
Change From Baseline in Body Temperature Body temperature, Visit 30 (Month 112), n=4	-0.02 Degree Celsius Standard Deviation 0.126
Change From Baseline in Body Temperature Body temperature, Visit 31 (Month 116), n=3	-0.20 Degree Celsius Standard Deviation 0.200
Change From Baseline in Body Temperature Body temperature, Visit 32 (Month 120), n=1	0.10 Degree Celsius Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed
Change From Baseline in Body Temperature Body temperature, Follow up, n=261	0.03 Degree Celsius Standard Deviation 0.397
Change From Baseline in Body Temperature Body temperature, Visit 7 (Month 20), n=176	0.04 Degree Celsius Standard Deviation 0.381
Change From Baseline in Body Temperature Body temperature, Visit 1 (Month 1), n=350	0.02 Degree Celsius Standard Deviation 0.386
Change From Baseline in Body Temperature Body temperature, Visit 2 (Month 3), n=318	0.02 Degree Celsius Standard Deviation 0.358
Change From Baseline in Body Temperature Body temperature, Visit 3 (Month 6), n=280	0.03 Degree Celsius Standard Deviation 0.384
Change From Baseline in Body Temperature Body temperature, Visit 4 (Month 9), n=244	0.00 Degree Celsius Standard Deviation 0.380
Change From Baseline in Body Temperature Body temperature, Visit 5 (Month 12), n=229	0.01 Degree Celsius Standard Deviation 0.392
Change From Baseline in Body Temperature Body temperature, Visit 6 (Month 16), n=197	0.02 Degree Celsius Standard Deviation 0.362
Change From Baseline in Body Temperature Body temperature, Visit 8 (Month 24), n=161	0.02 Degree Celsius Standard Deviation 0.387
Change From Baseline in Body Temperature Body temperature, Visit 9 (Month 28), n=143	0.01 Degree Celsius Standard Deviation 0.407
Change From Baseline in Body Temperature Body temperature, Visit 10 (Month 32), n=125	0.02 Degree Celsius Standard Deviation 0.362
Change From Baseline in Body Temperature Body temperature, Visit 11 (Month 36), n=118	0.02 Degree Celsius Standard Deviation 0.385
Change From Baseline in Body Temperature Body temperature, Visit 12 (Month 40), n=109	0.01 Degree Celsius Standard Deviation 0.404
Change From Baseline in Body Temperature Body temperature, Visit 13 (Month 44), n=101	0.04 Degree Celsius Standard Deviation 0.387
Change From Baseline in Body Temperature Body temperature, Visit 18 (Month 64), n=58	-0.01 Degree Celsius Standard Deviation 0.306
Change From Baseline in Body Temperature Body temperature, Visit 15 (Month 52), n=88	-0.02 Degree Celsius Standard Deviation 0.396
Change From Baseline in Body Temperature Body temperature, Visit 16 (Month 56), n=74	-0.01 Degree Celsius Standard Deviation 0.393
Change From Baseline in Body Temperature Body temperature, Visit 17 (Month 60), n=89	0.03 Degree Celsius Standard Deviation 0.391
Change From Baseline in Body Temperature Body temperature, Visit 19 (Month 68), n=53	0.05 Degree Celsius Standard Deviation 0.318
Change From Baseline in Body Temperature Body temperature, Visit 20 (Month 72), n=59	0.06 Degree Celsius Standard Deviation 0.373
Change From Baseline in Body Temperature Body temperature, Visit 21 (Month 76), n=42	0.06 Degree Celsius Standard Deviation 0.306
Change From Baseline in Body Temperature Body temperature, Visit 22 (Month 80), n=37	-0.04 Degree Celsius Standard Deviation 0.362
Change From Baseline in Body Temperature Body temperature, Visit 23 (Month 84), n=32	0.05 Degree Celsius Standard Deviation 0.324
Change From Baseline in Body Temperature Body temperature, Visit 24 (Month 88), n=29	-0.06 Degree Celsius Standard Deviation 0.313

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

Weight in pounds or kilograms was measured in ordinary indoor clothing (without shoes) and was recorded at all study visits during the Open-Label Treatment Phase of the study. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Change From Baseline in Body Weight Body weight, Visit 21 (Month 76), n=43	1.71 Kilograms Standard Deviation 9.355
Change From Baseline in Body Weight Body weight, Visit 26 (Month 96), n=26	0.12 Kilograms Standard Deviation 14.470
Change From Baseline in Body Weight Body weight, Visit 1 (Month 1), n=356	1.19 Kilograms Standard Deviation 3.125
Change From Baseline in Body Weight Body weight, Visit 2 (Month 3), n=325	1.37 Kilograms Standard Deviation 3.630
Change From Baseline in Body Weight Body weight, Visit 3 (Month 6), n=287	1.51 Kilograms Standard Deviation 4.528
Change From Baseline in Body Weight Body weight, Visit 4 (Month 9), n=252	1.08 Kilograms Standard Deviation 5.068
Change From Baseline in Body Weight Body weight, Visit 5 (Month 12), n=235	1.56 Kilograms Standard Deviation 4.764
Change From Baseline in Body Weight Body weight, Visit 6 (Month 16), n=202	1.98 Kilograms Standard Deviation 5.382
Change From Baseline in Body Weight Body weight, Visit 7 (Month 20), n=181	1.79 Kilograms Standard Deviation 5.762
Change From Baseline in Body Weight Body weight, Visit 8 (Month 24), n=167	1.20 Kilograms Standard Deviation 6.571
Change From Baseline in Body Weight Body weight, Visit 9 (Month 28), n=147	1.67 Kilograms Standard Deviation 6.101
Change From Baseline in Body Weight Body weight, Visit 10 (Month 32), n=128	1.75 Kilograms Standard Deviation 7.103
Change From Baseline in Body Weight Body weight, Visit 11 (Month 36), n=121	2.07 Kilograms Standard Deviation 7.151
Change From Baseline in Body Weight Body weight, Visit 12 (Month 40), 112	2.12 Kilograms Standard Deviation 7.077
Change From Baseline in Body Weight Body weight, Visit 13 (Month 44), n=105	1.09 Kilograms Standard Deviation 7.469
Change From Baseline in Body Weight Body weight, Visit 14 (Month 48), n=104	1.08 Kilograms Standard Deviation 8.007
Change From Baseline in Body Weight Body weight, Visit 15 (Month 52), n=91	0.66 Kilograms Standard Deviation 7.539
Change From Baseline in Body Weight Body weight, Visit 16 (Month 56), n=77	0.71 Kilograms Standard Deviation 7.248
Change From Baseline in Body Weight Body weight, Visit 17 (Month 60), n=91	1.31 Kilograms Standard Deviation 8.082
Change From Baseline in Body Weight Body weight, Visit 18 (Month 64), n=58	1.32 Kilograms Standard Deviation 7.541
Change From Baseline in Body Weight Body weight, Visit 19 (Month 68), n=53	1.49 Kilograms Standard Deviation 8.036
Change From Baseline in Body Weight Body weight, Visit 20 (Month 72), n=61	1.65 Kilograms Standard Deviation 8.774
Change From Baseline in Body Weight Body weight, Visit 22 (Month 80), n=37	2.30 Kilograms Standard Deviation 9.311
Change From Baseline in Body Weight Body weight, Visit 23 (Month 84), n=32	2.00 Kilograms Standard Deviation 9.522
Change From Baseline in Body Weight Body weight, Visit 24 (Month 88), n=29	1.12 Kilograms Standard Deviation 9.633
Change From Baseline in Body Weight Body weight, Visit 25 (Month 92), n=25	0.83 Kilograms Standard Deviation 10.845
Change From Baseline in Body Weight Body weight, Visit 27 (Month 100), n=20	1.57 Kilograms Standard Deviation 11.382
Change From Baseline in Body Weight Body weight, Visit 28 (Month 104), n=17	1.62 Kilograms Standard Deviation 10.715
Change From Baseline in Body Weight Body weight, Visit 29 (Month 108), n=13	2.32 Kilograms Standard Deviation 13.914
Change From Baseline in Body Weight Body weight, Visit 30 (Month 112), n=4	4.85 Kilograms Standard Deviation 17.693
Change From Baseline in Body Weight Body weight, Visit 31 (Month 116), n=3	9.73 Kilograms Standard Deviation 17.234
Change From Baseline in Body Weight Body weight, Visit 32 (Month 120), n=1	0.50 Kilograms Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Body Weight Body weight, Follow up, n=267	1.34 Kilograms Standard Deviation 5.870

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

A 12-lead ECG was performed at all study visits during the Open-Label Treatment Phase during the first year of the open-label extension study (Months 1, 3, 6, 9, 12) and at the end of each 12 month study cycle that the participant was enrolled (i.e., second year, third year, fourth year, etc.). The ECG parameters that were assessed were PR interval, QRS interval, QRS duration, QT interval, and QTc interval. QT intervals were corrected using both Bazett's and Friedericia's formulas. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Bazett interval, Visit 3 (Month 6), n=278	3.4 Milliseconds Standard Deviation 16.97
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia PR interval, Visit 2 (Month 3), n=324	-0.4 Milliseconds Standard Deviation 11.95
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QT interval, Visit 2 (Month 3), n=324	4.8 Milliseconds Standard Deviation 23.35
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia PR interval, Visit 1 (Month 1), n=355	0.1 Milliseconds Standard Deviation 13.47
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia PR interval, Visit 3 (Month 6), n=278	-1.0 Milliseconds Standard Deviation 13.18
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia PR interval, Visit 4 (Month 9), n=245	-1.7 Milliseconds Standard Deviation 12.74
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia PR interval, Visit 5 (Month 12), n=233	-1.7 Milliseconds Standard Deviation 13.01
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia PR interval, Visit 8 (Month 24), n=158	-2.1 Milliseconds Standard Deviation 15.23
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia PR interval, Visit 11 (Month 36), n=113	-1.6 Milliseconds Standard Deviation 14.20
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia PR interval, Visit 14 (Month 48), n=98	0.3 Milliseconds Standard Deviation 13.30
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia PR interval, Visit 17 (Month 60), n=87	0.7 Milliseconds Standard Deviation 13.70
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia PR interval, Visit 20 (Month 72), n=52	0.9 Milliseconds Standard Deviation 14.07
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia PR interval, Visit 23 (Month 84), n=30	-3.5 Milliseconds Standard Deviation 13.06
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia PR interval, Visit 26 (Month 96), n=22	-4.4 Milliseconds Standard Deviation 11.96
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia PR interval, Visit 29 (Month 108), n=13	-1.9 Milliseconds Standard Deviation 11.50
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia PR interval, Visit 32 (Month 120), n=1	-23.7 Milliseconds Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia PR interval, Follow up, n=252	-1.3 Milliseconds Standard Deviation 12.83
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QRS duration, Visit 1 (Month 1), n=357	-0.6 Milliseconds Standard Deviation 8.03
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QRS duration, Visit 2 (Month 3), n=327	-1.1 Milliseconds Standard Deviation 7.53
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QRS duration, Visit 3 (Month 6), n=282	-1.2 Milliseconds Standard Deviation 7.34
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QRS duration, Visit 4 (Month 9), n=249	-1.4 Milliseconds Standard Deviation 6.59
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QRS duration, Visit 5 (Month 12), n=235	-0.1 Milliseconds Standard Deviation 8.09
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QRS duration, Visit 8 (Month 24), n=160	-1.1 Milliseconds Standard Deviation 7.74
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QRS duration, Visit 11 (Month 36), n=116	1.5 Milliseconds Standard Deviation 7.66
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QRS duration, Visit 14 (Month 48), n=99	1.1 Milliseconds Standard Deviation 7.92
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QRS duration, Visit 17 (Month 60), n=89	3.3 Milliseconds Standard Deviation 12.89
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QRS duration, Visit 20 (Month 72), n=56	5.2 Milliseconds Standard Deviation 16.42
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QRS duration, Visit 23 (Month 84), n=32	3.4 Milliseconds Standard Deviation 18.65
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QRS duration Visit 26 (Month 96), n=23	3.5 Milliseconds Standard Deviation 24.77
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QRS duration, Visit 29 (Month 108), n=13	1.2 Milliseconds Standard Deviation 7.73
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QRS duration, Visit 32 (Month 120), n=1	10.7 Milliseconds Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QRS duration, Follow up, n=254	-0.1 Milliseconds Standard Deviation 8.74
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QT interval, Visit 1 (Month 1), n=357	5.5 Milliseconds Standard Deviation 23.66
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QT interval, Visit 3 (Month 6), n=278	5.3 Milliseconds Standard Deviation 23.10
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QT interval, Visit 4 (Month 9), n=246	3.9 Milliseconds Standard Deviation 23.47
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QT interval, Visit 5 (Month 12), n=232	5.0 Milliseconds Standard Deviation 24.37
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QT interval, Visit 8 (Month 24), n=157	3.4 Milliseconds Standard Deviation 25.09
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QT interval, Visit 11 (Month 36), n=112	8.8 Milliseconds Standard Deviation 24.66
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QT interval, Visit 14 (Month 48), n=96	7.0 Milliseconds Standard Deviation 22.57
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QT interval, Visit 17 (Month 60), n=89	7.9 Milliseconds Standard Deviation 23.55
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QT interval, Visit 20 (Month 72), n=56	12.4 Milliseconds Standard Deviation 28.30
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QT interval, Visit 23 (Month 84), n=32	8.4 Milliseconds Standard Deviation 30.17
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QT interval, Visit 26 (Month 96), n=23	4.0 Milliseconds Standard Deviation 31.01
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QT interval, Visit 29 (Month 108), n=13	0.8 Milliseconds Standard Deviation 29.90
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QT interval, Visit 32 (Month 120), n=1	64.0 Milliseconds Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QT interval, Follow up, n=254	1.2 Milliseconds Standard Deviation 24.95
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Bazett interval, Visit 1 (Month 1, n=357	1.2 Milliseconds Standard Deviation 18.07
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Bazett interval, Visit 2 (Month 3), n=324	1.6 Milliseconds Standard Deviation 18.09
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Bazett interval, Visit 4 (Month 9, n=246	4.4 Milliseconds Standard Deviation 17.33
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Bazett interval, Visit 5 (Month 12), n=232	2.3 Milliseconds Standard Deviation 16.61
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Bazett interval, Visit 8 (Month 24), n=157	6.6 Milliseconds Standard Deviation 18.27
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Bazett interval, Visit 11 (Month 36), n=112	4.5 Milliseconds Standard Deviation 18.10
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Bazett interval, Visit 14 (Month 48), n=96	5.6 Milliseconds Standard Deviation 18.18
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Bazett interval, Visit 17 (Month 60), n=89	12.4 Milliseconds Standard Deviation 25.68
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Bazett interval, Visit 20 (Month 72), n=56	15.6 Milliseconds Standard Deviation 24.79
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Bazett interval, Visit 23 (Month 84), n=32	18.7 Milliseconds Standard Deviation 23.90
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Bazett interval, Visit 26 (Month 96, n=23	19.7 Milliseconds Standard Deviation 28.67
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Bazett interval, Visit 29 (Month 108), n=13	17.6 Milliseconds Standard Deviation 21.09
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Bazett interval, Visit 32 (Month 120), n=1	0.7 Milliseconds Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Bazett interval, Follow up, n=254	4.9 Milliseconds Standard Deviation 18.39
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Friedericia interval, Visit 1 (Month 1),n=357	2.7 Milliseconds Standard Deviation 15.72
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Friedericia interval Visit 2 (Month 3),n=324	2.7 Milliseconds Standard Deviation 15.88
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Friedericia interval,Visit 3 (Month 6),n=278	4.0 Milliseconds Standard Deviation 15.59
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Friedericia interval, Visit 4 (Month 9),n=246	4.1 Milliseconds Standard Deviation 15.86
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Friedericia intervalVisit 5 (Month 12),n=232	3.2 Milliseconds Standard Deviation 15.62
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Friedericia interval,Visit 8 (Month 24),n=157	5.4 Milliseconds Standard Deviation 15.00
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Friedericia intervalVisit 11 (Month 36),n=112	5.9 Milliseconds Standard Deviation 15.69
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Friedericia interval,Visit 14 (Month 48),n=96	6.1 Milliseconds Standard Deviation 15.08
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Friedericia interval,Visit 17 (Month 60),n=89	10.8 Milliseconds Standard Deviation 18.93
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Friedericia intervalVisit 20 (Month 72),n=56	14.4 Milliseconds Standard Deviation 19.28
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Friedericia intervalVisit 23 (Month 84),n=32	15.0 Milliseconds Standard Deviation 20.97
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Friedericia interval,Visit 26 (Month 96),n=23	14.3 Milliseconds Standard Deviation 22.90
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTcFriedericia intervalVisit 29 (Month 108)n=13	11.6 Milliseconds Standard Deviation 17.76
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTc Friedericia interval,Visit 32 (Month 120),n=1	23.7 Milliseconds Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Electocardiogram (ECG) Parameters PR, QRS, QT, Corrected QT Interval (QTc) Bazett and QTc Friedericia QTcFriedericia interval, Follow up,n=254	3.5 Milliseconds Standard Deviation 16.58

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

Clinical chemistry parameters included Alk. Phos., ALT and AST. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 14 (Month 48), n=101	-7.2 International units per liter Standard Deviation 21.34
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 15 (Month 52), n=88	-2.5 International units per liter Standard Deviation 23.46
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 16 (Month 56), n=74	3.7 International units per liter Standard Deviation 8.77
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 17 (Month 60), n=89	3.6 International units per liter Standard Deviation 6.57
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 18 (Month 64), n=54	2.1 International units per liter Standard Deviation 8.24
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 19 (Month 68), n=50	2.3 International units per liter Standard Deviation 7.22
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 20 (Month 72), n=58	4.0 International units per liter Standard Deviation 10.35
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 21 (Month 76), n=39	3.9 International units per liter Standard Deviation 10.22
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 22 (Month 80), n=35	3.8 International units per liter Standard Deviation 11.96
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 23 (Month 84), n=32	1.9 International units per liter Standard Deviation 9.96
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 24 (Month 88), n=28	3.5 International units per liter Standard Deviation 11.21
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 25 (Month 92), n=25	1.3 International units per liter Standard Deviation 9.09
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 28 (Month 104), n=16	3.2 International units per liter Standard Deviation 10.71
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 30 (Month 112), n=4	-4.5 International units per liter Standard Deviation 10.60
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 32 (Month 120), n=1	7.0 International units per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 1 (Month 1), n=352	-0.9 International units per liter Standard Deviation 14.47
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 1a (Month 2), n=1	-18.0 International units per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 2 (Month 3), n=322	-1.5 International units per liter Standard Deviation 14.56
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 2a (Month 4), n=1	4.0 International units per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 3 (Month 6), n=279	-1.2 International units per liter Standard Deviation 14.91
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 4 (Month 9), n=248	-3.0 International units per liter Standard Deviation 14.25
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 5 (Month 12), n=228	-1.9 International units per liter Standard Deviation 15.06
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 6 (Month 16), n=200	-1.8 International units per liter Standard Deviation 15.96
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 7 (Month 20), n=176	-3.6 International units per liter Standard Deviation 17.32
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 8 (Month 24), n=163	-4.0 International units per liter Standard Deviation 17.68
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 9 (Month 28), n=142	-3.1 International units per liter Standard Deviation 17.88
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 10 (Month 32), n=126	-4.6 International units per liter Standard Deviation 18.94
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 11 (Month 36), n=116	-6.2 International units per liter Standard Deviation 22.36
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 12 (Month 40), n=108	-4.8 International units per liter Standard Deviation 21.05
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 32 (Month 120), n=1	1.0 International units per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 13 (Month 44), n=101	-5.8 International units per liter Standard Deviation 21.53
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 16 (Month 56), n=76	-0.1 International units per liter Standard Deviation 19.72
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 17 (Month 60), n=90	-5.1 International units per liter Standard Deviation 21.15
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 18 (Month 64), n=55	-2.0 International units per liter Standard Deviation 18.95
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 19 (Month 68), n=50	-0.6 International units per liter Standard Deviation 14.60
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 20 (Month 72), n=58	0.3 International units per liter Standard Deviation 23.56
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 21 (Month 76), n=40	0.8 International units per liter Standard Deviation 15.41
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 22 (Month 80), n=35	3.2 International units per liter Standard Deviation 19.97
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 23 (Month 84), n=32	0.2 International units per liter Standard Deviation 16.54
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 24 (Month 88), n=28	-0.1 International units per liter Standard Deviation 19.55
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 25 (Month 92), n=25	1.5 International units per liter Standard Deviation 21.27
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 26 (Month 96), n=26	4.8 International units per liter Standard Deviation 23.10
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 27 (Month 100), n=20	4.1 International units per liter Standard Deviation 14.67
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 28 (Month 104), n=16	8.6 International units per liter Standard Deviation 21.80
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 29 (Month 108), n=13	6.6 International units per liter Standard Deviation 17.94
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 30 (Month 112), n=4	1.8 International units per liter Standard Deviation 14.57
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 31 (Month 116), n=3	3.0 International units per liter Standard Deviation 3.61
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Visit 32 (Month 120), n=1	1.0 International units per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) Alk. Phos., Follow up, n=261	-0.4 International units per liter Standard Deviation 18.15
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 1 (Month 1), n=352	2.6 International units per liter Standard Deviation 20.05
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 1a (Month 2), n=1	-24.0 International units per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 2 (Month 3), n=322	1.5 International units per liter Standard Deviation 16.57
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 2a (Month 4), n=1	45.0 International units per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 3 (Month 6), n=278	1.3 International units per liter Standard Deviation 13.99
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 4 (Month 9), n=246	-0.2 International units per liter Standard Deviation 10.94
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 5 (Month 12), n=227	3.4 International units per liter Standard Deviation 28.91
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 6 (Month 16), n=200	1.3 International units per liter Standard Deviation 12.56
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 7 (Month 20), n=174	1.2 International units per liter Standard Deviation 17.23
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 8 (Month 24), n=163	0.5 International units per liter Standard Deviation 11.03
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 9 (Month 28), n=141	1.7 International units per liter Standard Deviation 16.40
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 10 (Month 32), n=126	1.0 International units per liter Standard Deviation 9.95
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 11 (Month 36), n=115	0.1 International units per liter Standard Deviation 8.11
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 12 (Month 40), n=107	0.9 International units per liter Standard Deviation 8.49
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 13 (Month 44), n=101	0.6 International units per liter Standard Deviation 8.39
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 14 (Month 48), n=99	0.5 International units per liter Standard Deviation 8.47
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 15 (Month 52), n=88	0.9 International units per liter Standard Deviation 9.83
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 16 (Month 56), n=75	1.3 International units per liter Standard Deviation 9.16
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 17 (Month 60), n=89	0.0 International units per liter Standard Deviation 8.06
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 18 (Month 64), n=54	-0.8 International units per liter Standard Deviation 7.12
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 19 (Month 68), n=50	-0.5 International units per liter Standard Deviation 7.57
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 20 (Month 72), n=58	0.6 International units per liter Standard Deviation 10.70
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 21 (Month 76), n=39	0.3 International units per liter Standard Deviation 10.65
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 22 (Month 80), n=35	0.1 International units per liter Standard Deviation 16.27
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 23 (Month 84), n=32	-2.3 International units per liter Standard Deviation 7.95
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 24 (Month 88), n=28	-4.1 International units per liter Standard Deviation 9.45
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 25 (Month 92), n=25	-4.2 International units per liter Standard Deviation 9.99
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 26 (Month 96), n=26	-1.6 International units per liter Standard Deviation 11.74
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 27 (Month 100), n=20	-3.2 International units per liter Standard Deviation 6.76
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 28 (Month 104), n=16	-3.1 International units per liter Standard Deviation 12.15
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 29 (Month 108), n=13	-3.6 International units per liter Standard Deviation 8.65
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 30 (Month 112), n=4	-5.3 International units per liter Standard Deviation 11.84
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Visit 31 (Month 116), n=3	2.3 International units per liter Standard Deviation 18.15
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) ALT, Follow up, n=259	5.5 International units per liter Standard Deviation 64.04
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 1 (Month 1), n=352	2.1 International units per liter Standard Deviation 13.00
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 1a (Month 2), n=1	-65.0 International units per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 2 (Month 3), n=322	1.8 International units per liter Standard Deviation 14.76
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 2a (Month 4), n=1	24.0 International units per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 3 (Month 6), n=278	1.0 International units per liter Standard Deviation 9.60
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 4 (Month 9), n=246	0.7 International units per liter Standard Deviation 8.90
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 5 (Month 12), n=227	3.0 International units per liter Standard Deviation 16.88
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 6 (Month 16), n=200	1.7 International units per liter Standard Deviation 7.95
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 7 (Month 20), n=174	2.7 International units per liter Standard Deviation 10.53
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 8 (Month 24), n=162	2.7 International units per liter Standard Deviation 8.42
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 9 (Month 28), n=141	3.3 International units per liter Standard Deviation 11.36
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 10 (Month 32), n=126	3.3 International units per liter Standard Deviation 7.36
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 11 (Month 36), n=115	3.2 International units per liter Standard Deviation 7.77
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 12 (Month 40), n=106	3.6 International units per liter Standard Deviation 8.78
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 13 (Month 44), n=101	3.7 International units per liter Standard Deviation 8.37
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 14 (Month 48), n=99	3.9 International units per liter Standard Deviation 7.67
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 15 (Month 52), n=87	2.7 International units per liter Standard Deviation 8.15
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 26 (Month 96), n=26	2.5 International units per liter Standard Deviation 9.78
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 27 (Month 100), n=20	1.6 International units per liter Standard Deviation 7.67
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 29 (Month 108), n=13	0.7 International units per liter Standard Deviation 8.70
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Visit 31 (Month 116), n=3	2.7 International units per liter Standard Deviation 23.03
Change From Baseline in Alkaline Phosphatase (Alk. Phos.), Alanine Amino Transferase (ALT) and Aspartate Amino Transferase (AST) AST, Follow up, n=257	3.4 International units per liter Standard Deviation 36.36

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

Clinical chemistry parameters included bicarbonate, calcium, chloride, cholesterol, Non-fasting Glucose, phosphorus, potassium, sodium and urea. Approximately 7-milliliter sample of blood was drawn for clinical chemistry assays. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 1a (Month 2), n=1	-2.0 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 2 (Month 3), n=316	-0.3 Millimoles per liter Standard Deviation 3.34
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 7 (Month 20), n=171	-0.2 Millimoles per liter Standard Deviation 3.22
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 8 (Month 24), n=159	-0.2 Millimoles per liter Standard Deviation 3.26
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 9 (Month 28), n=140	-0.1 Millimoles per liter Standard Deviation 3.44
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 10 (Month 32), n=126	-0.5 Millimoles per liter Standard Deviation 3.74
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 11 (Month 36), n=116	-0.4 Millimoles per liter Standard Deviation 3.54
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 12 (Month 40), n=107	0.0 Millimoles per liter Standard Deviation 3.52
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 13 (Month 44), n=100	0.4 Millimoles per liter Standard Deviation 3.41
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 14 (Month 48), n=101	-0.1 Millimoles per liter Standard Deviation 3.56
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 15 (Month 52), n=86	0.5 Millimoles per liter Standard Deviation 3.77
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 16 (Month 56), n=76	-0.1 Millimoles per liter Standard Deviation 3.07
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 17 (Month 60), n=90	-0.1 Millimoles per liter Standard Deviation 3.45
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 18 (Month 64), n=55	-0.7 Millimoles per liter Standard Deviation 3.93
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 19 (Month 68), n=49	-1.1 Millimoles per liter Standard Deviation 4.11
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 21 (Month 76), n=39	-0.2 Millimoles per liter Standard Deviation 3.58
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 24 (Month 88), n=28	-0.7 Millimoles per liter Standard Deviation 3.56
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 25 (Month 92), n=25	-1.8 Millimoles per liter Standard Deviation 3.15
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 26 (Month 96), n=25	-1.0 Millimoles per liter Standard Deviation 3.48
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 27 (Month 100), n=20	-1.3 Millimoles per liter Standard Deviation 3.91
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 28 (Month 104), n=15	-1.9 Millimoles per liter Standard Deviation 3.70
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 29 (Month 108), n=13	-1.8 Millimoles per liter Standard Deviation 2.35
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 30 (Month 112), n=4	-2.0 Millimoles per liter Standard Deviation 1.41
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 32 (Month 120), n=1	2.0 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 3 (Month 6), n=279	0.9 Millimoles per liter Standard Deviation 3.52
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 4 (Month 9), n=248	1.0 Millimoles per liter Standard Deviation 3.46
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 5 (Month 12), n=228	1.2 Millimoles per liter Standard Deviation 3.75
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 9 (Month 28), n=143	2.1 Millimoles per liter Standard Deviation 4.45
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 18 (Month 64), n=55	2.3 Millimoles per liter Standard Deviation 3.33
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 20 (Month 72), n=58	0.2 Millimoles per liter Standard Deviation 5.33
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 2 (Month 3), n=322	0.108 Millimoles per liter Standard Deviation 0.6368
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 7 (Month 20), n=176	0.001 Millimoles per liter Standard Deviation 0.7820
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 18 (Month 64), n=55	0.054 Millimoles per liter Standard Deviation 0.7474
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 20 (Month 72), n=58	-0.048 Millimoles per liter Standard Deviation 0.8221
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 2 (Month 3), n=321	0.17 Millimoles per liter Standard Deviation 1.002
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 10 (Month 32), n=126	0.03 Millimoles per liter Standard Deviation 0.976
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 18 (Month 64), n=55	0.14 Millimoles per liter Standard Deviation 1.125
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 21 (Month 76), n=40	0.03 Millimoles per liter Standard Deviation 0.895
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 22 (Month 80), n=35	0.29 Millimoles per liter Standard Deviation 1.116
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 24 (Month 88), n=28	0.14 Millimoles per liter Standard Deviation 1.017
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 25 (Month 92), n=25	0.28 Millimoles per liter Standard Deviation 1.105
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 31 (Month 116), n=3	0.70 Millimoles per liter Standard Deviation 1.127
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 9 (Month 28), n=142	-0.011 Millimoles per liter Standard Deviation 0.2146
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 17 (Month 60), n=89	-0.047 Millimoles per liter Standard Deviation 0.2419
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 18 (Month 64), n=55	-0.059 Millimoles per liter Standard Deviation 0.2540
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 22 (Month 80), n=35	-0.071 Millimoles per liter Standard Deviation 0.2930
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 29 (Month 108), n=13	-0.300 Millimoles per liter Standard Deviation 0.1534
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 15 (Month 52), n=89	-0.01 Millimoles per liter Standard Deviation 0.436
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 16 (Month 56), n=75	0.00 Millimoles per liter Standard Deviation 0.506
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 32 (Month 120), n=1	-0.30 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 19 (Month 68), n=51	2.2 Millimoles per liter Standard Deviation 3.63
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 25 (Month 92), n=25	1.4 Millimoles per liter Standard Deviation 5.45
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 29 (Month 108), n=13	0.5 Millimoles per liter Standard Deviation 4.58
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 1a (Month 2), n=1	2.860 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 5 (Month 12), n=228	0.599 Millimoles per liter Standard Deviation 1.3323
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Follow up, n=260	0.158 Millimoles per liter Standard Deviation 1.2473
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 1 (Month 1), n=344	-0.2 Millimoles per liter Standard Deviation 3.02
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 26 (Month 96), n=26	0.489 Millimoles per liter Standard Deviation 1.0353
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 27 (Month 100), n=20	0.370 Millimoles per liter Standard Deviation 0.6675
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 28 (Month 104), n=16	0.354 Millimoles per liter Standard Deviation 0.6488
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 29 (Month 108), n=13	0.141 Millimoles per liter Standard Deviation 1.0346
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 30 (Month 112), n=4	1.775 Millimoles per liter Standard Deviation 0.9858
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 31 (Month 116), n=3	1.123 Millimoles per liter Standard Deviation 0.8723
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 32 (Month 120), n=1	0.050 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Follow up, n=261	-0.070 Millimoles per liter Standard Deviation 0.7047
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 1 (Month 1), n=351	0.06 Millimoles per liter Standard Deviation 0.885
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 1a (Month 2), n=1	-0.30 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 2a (Month 4), n=1	0.40 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 3 (Month 6), n=278	0.12 Millimoles per liter Standard Deviation 0.804
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 4 (Month 9), n=247	0.16 Millimoles per liter Standard Deviation 1.066
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 5 (Month 12), n=227	0.16 Millimoles per liter Standard Deviation 0.906
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 6 (Month 16), n=199	0.10 Millimoles per liter Standard Deviation 0.851
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 7 (Month 20), n=176	0.02 Millimoles per liter Standard Deviation 0.843
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 8 (Month 24), n=161	0.12 Millimoles per liter Standard Deviation 0.858
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 9 (Month 28), n=142	0.04 Millimoles per liter Standard Deviation 0.842
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 11 (Month 36), n=115	0.08 Millimoles per liter Standard Deviation 0.951
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 12 (Month 40), n=108	0.06 Millimoles per liter Standard Deviation 0.938
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 13 (Month 44), n=100	0.07 Millimoles per liter Standard Deviation 0.912
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 14 (Month 48), n=101	-0.04 Millimoles per liter Standard Deviation 0.881
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 15 (Month 52), n=88	0.08 Millimoles per liter Standard Deviation 0.745
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 16 (Month 56), n=75	0.19 Millimoles per liter Standard Deviation 0.931
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 17 (Month 60), n=89	0.08 Millimoles per liter Standard Deviation 0.773
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 3 (Month 6), n=272	0.0 Millimoles per liter Standard Deviation 3.06
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 4 (Month 9), n=243	-0.3 Millimoles per liter Standard Deviation 3.22
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 19 (Month 68), n=49	0.05 Millimoles per liter Standard Deviation 0.816
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 20 (Month 72), n=58	0.16 Millimoles per liter Standard Deviation 0.878
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 5 (Month 12), n=221	-0.8 Millimoles per liter Standard Deviation 3.18
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 6 (Month 16), n=196	-0.2 Millimoles per liter Standard Deviation 3.11
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 20 (Month 72), n=56	-1.2 Millimoles per liter Standard Deviation 3.81
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 22 (Month 80), n=35	-1.0 Millimoles per liter Standard Deviation 3.24
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 23 (Month 84), n=32	-1.3 Millimoles per liter Standard Deviation 3.17
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Visit 31 (Month 116), n=3	3.3 Millimoles per liter Standard Deviation 6.11
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Bicarbonate, Follow up, n=256	-1.0 Millimoles per liter Standard Deviation 3.19
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 1 (Month 1), n=352	0.000 Millimoles per liter Standard Deviation 0.1187
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 1a (Month 2), n=1	-0.250 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 2 (Month 3), n=322	0.008 Millimoles per liter Standard Deviation 0.1146
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 2a (Month 4), n=1	-0.100 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 3 (Month 6), n=279	0.018 Millimoles per liter Standard Deviation 0.1169
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 4 (Month 9), n=248	0.022 Millimoles per liter Standard Deviation 0.1187
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 5 (Month 12), n=228	0.010 Millimoles per liter Standard Deviation 0.1269
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 6 (Month 16), n=200	0.005 Millimoles per liter Standard Deviation 0.1168
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 7 (Month 20), n=176	0.005 Millimoles per liter Standard Deviation 0.1118
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 8 (Month 24), n=163	0.014 Millimoles per liter Standard Deviation 0.1193
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 9 (Month 28), n=142	0.015 Millimoles per liter Standard Deviation 0.1154
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 10 (Month 32), n=126	0.023 Millimoles per liter Standard Deviation 0.1161
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 11 (Month 36), n=116	0.017 Millimoles per liter Standard Deviation 0.1274
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 12 (Month 40), n=108	0.035 Millimoles per liter Standard Deviation 0.1239
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 13 (Month 44), n=101	0.028 Millimoles per liter Standard Deviation 0.1168
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 14 (Month 48), n=101	0.025 Millimoles per liter Standard Deviation 0.1176
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 15 (Month 52), n=88	0.020 Millimoles per liter Standard Deviation 0.1225
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 16 (Month 56), n=76	0.016 Millimoles per liter Standard Deviation 0.1227
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 17 (Month 60), n=90	0.008 Millimoles per liter Standard Deviation 0.1172
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 18 (Month 64), n=55	-0.007 Millimoles per liter Standard Deviation 0.1270
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 19 (Month 68), n=51	0.019 Millimoles per liter Standard Deviation 0.1177
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 20 (Month 72), n=58	-0.012 Millimoles per liter Standard Deviation 0.1298
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 21 (Month 76), n=40	0.020 Millimoles per liter Standard Deviation 0.1257
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 22 (Month 80), n=35	0.079 Millimoles per liter Standard Deviation 0.1531
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 23 (Month 84), n=32	0.038 Millimoles per liter Standard Deviation 0.1113
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 24 (Month 88), n=28	0.034 Millimoles per liter Standard Deviation 0.1497
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 8 (Month 24), n=163	0.652 Millimoles per liter Standard Deviation 1.5332
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 25 (Month 92), n=25	0.089 Millimoles per liter Standard Deviation 0.1560
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 26 (Month 96), n=26	0.075 Millimoles per liter Standard Deviation 0.1636
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 27 (Month 100), n=20	0.121 Millimoles per liter Standard Deviation 0.1552
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 28 (Month 104), n=16	0.091 Millimoles per liter Standard Deviation 0.1653
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 29 (Month 108), n=13	0.080 Millimoles per liter Standard Deviation 0.1297
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 30 (Month 112), n=4	0.133 Millimoles per liter Standard Deviation 0.1063
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 31 (Month 116), n=3	0.053 Millimoles per liter Standard Deviation 0.1124
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Visit 32 (Month 120), n=1	-0.040 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Calcium, Follow up, n=261	0.031 Millimoles per liter Standard Deviation 0.1245
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 1 (Month 1), n=352	0.1 Millimoles per liter Standard Deviation 3.48
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 1a (Month 2), n=1	1.0 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 2 (Month 3), n=322	0.3 Millimoles per liter Standard Deviation 3.49
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 2a (Month 4), n=1	2.0 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 6 (Month 16), n=200	1.8 Millimoles per liter Standard Deviation 3.73
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 7 (Month 20), n=176	2.0 Millimoles per liter Standard Deviation 4.09
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 8 (Month 24), n=164	1.8 Millimoles per liter Standard Deviation 4.42
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 10 (Month 32), n=127	1.3 Millimoles per liter Standard Deviation 4.22
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 11 (Month 36), n=118	1.3 Millimoles per liter Standard Deviation 4.55
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 12 (Month 40), n=108	2.4 Millimoles per liter Standard Deviation 4.68
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 13 (Month 44), n=103	2.2 Millimoles per liter Standard Deviation 4.59
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 14 (Month 48), n=102	1.2 Millimoles per liter Standard Deviation 4.91
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 15 (Month 52), n=89	2.0 Millimoles per liter Standard Deviation 4.63
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 16 (Month 56), n=76	1.6 Millimoles per liter Standard Deviation 4.51
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 17 (Month 60), n=91	1.3 Millimoles per liter Standard Deviation 5.16
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 19 (Month 68), n=51	0.9 Millimoles per liter Standard Deviation 4.22
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 21 (Month 76), n=40	0.6 Millimoles per liter Standard Deviation 4.11
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 22 (Month 80), n=35	0.8 Millimoles per liter Standard Deviation 3.30
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 23 (Month 84), n=32	1.1 Millimoles per liter Standard Deviation 4.33
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 24 (Month 88), n=28	0.8 Millimoles per liter Standard Deviation 3.94
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 25 (Month 92), n=25	-0.4 Millimoles per liter Standard Deviation 5.97
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 26 (Month 96), n=26	-0.4 Millimoles per liter Standard Deviation 4.56
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 27 (Month 100), n=20	0.1 Millimoles per liter Standard Deviation 5.31
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 28 (Month 104), n=16	-1.1 Millimoles per liter Standard Deviation 4.86
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 29 (Month 108), n=13	-1.0 Millimoles per liter Standard Deviation 5.66
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride,Visit 30 (Month 112), n=4	-3.0 Millimoles per liter Standard Deviation 4.24
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride,Visit 31 (Month 116), n=3	-2.3 Millimoles per liter Standard Deviation 5.03
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Visit 32 (Month 120), n=1	-3.0 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Chloride, Follow up, n=261	0.3 Millimoles per liter Standard Deviation 4.03
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 1 (Month 1), n=352	0.066 Millimoles per liter Standard Deviation 0.6255
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 1a (Month 2), n=1	-0.360 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 9 (Month 28), n=142	0.578 Millimoles per liter Standard Deviation 1.3512
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 2a (Month 4), n=1	-0.470 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 3 (Month 6), n=279	0.062 Millimoles per liter Standard Deviation 0.6978
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 4 (Month 9), n=248	0.062 Millimoles per liter Standard Deviation 0.7238
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 5 (Month 12), n=228	0.075 Millimoles per liter Standard Deviation 0.7074
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 6 (Month 16), n=200	0.101 Millimoles per liter Standard Deviation 0.7601
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 8 (Month 24), n=163	0.087 Millimoles per liter Standard Deviation 0.8471
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 9 (Month 28), n=142	-0.001 Millimoles per liter Standard Deviation 0.7732
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 10 (Month 32), n=126	-0.028 Millimoles per liter Standard Deviation 0.8520
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 11 (Month 36), n=116	-0.087 Millimoles per liter Standard Deviation 0.7823
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 12 (Month 40), n=108	-0.001 Millimoles per liter Standard Deviation 0.7830
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 13 (Month 44), n=101	-0.043 Millimoles per liter Standard Deviation 0.8053
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 14 (Month 48), n=101	-0.128 Millimoles per liter Standard Deviation 0.7505
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 15 (Month 52), n=88	-0.057 Millimoles per liter Standard Deviation 0.7427
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 16 (Month 56), n=76	0.026 Millimoles per liter Standard Deviation 0.7354
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 17 (Month 60), n=90	0.016 Millimoles per liter Standard Deviation 0.8209
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 23 (Month 84), n=32	-0.01 Millimoles per liter Standard Deviation 0.903
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 19 (Month 68), n=50	0.074 Millimoles per liter Standard Deviation 0.8943
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 21 (Month 76), n=40	0.103 Millimoles per liter Standard Deviation 0.9056
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 26 (Month 96), n=26	0.50 Millimoles per liter Standard Deviation 1.381
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 27 (Month 100), n=20	0.18 Millimoles per liter Standard Deviation 1.022
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 28 (Month 104), n=16	0.74 Millimoles per liter Standard Deviation 0.916
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 29 (Month 108), n=13	0.25 Millimoles per liter Standard Deviation 0.989
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 30 (Month 112), n=4	0.65 Millimoles per liter Standard Deviation 0.839
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 22 (Month 80), n=35	0.096 Millimoles per liter Standard Deviation 0.8671
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Visit 32 (Month 120), n=1	-0.30 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Non-fasting Glucose, Follow up, n=259	0.18 Millimoles per liter Standard Deviation 1.068
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 23 (Month 84), n=32	0.077 Millimoles per liter Standard Deviation 0.9637
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 1 (Month 1), n=351	0.017 Millimoles per liter Standard Deviation 0.1991
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 24 (Month 88), n=28	0.310 Millimoles per liter Standard Deviation 0.8553
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 1a (Month 2), n=1	0.030 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 2 (Month 3), n=320	0.014 Millimoles per liter Standard Deviation 0.2011
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 2a (Month 4), n=1	0.160 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 3 (Month 6), n=278	-0.001 Millimoles per liter Standard Deviation 0.2125
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Cholesterol, Visit 25 (Month 92), n=25	0.327 Millimoles per liter Standard Deviation 0.8143
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 4 (Month 9), n=247	-0.009 Millimoles per liter Standard Deviation 0.1912
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 5 (Month 12), n=227	-0.016 Millimoles per liter Standard Deviation 0.2130
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 6 (Month 16), n=199	-0.023 Millimoles per liter Standard Deviation 0.1994
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 7 (Month 20), n=176	-0.022 Millimoles per liter Standard Deviation 0.2224
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 8 (Month 24), n=161	-0.012 Millimoles per liter Standard Deviation 0.2332
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 10 (Month 32), n=126	-0.005 Millimoles per liter Standard Deviation 0.2231
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 11 (Month 36), n=115	-0.026 Millimoles per liter Standard Deviation 0.2284
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 12 (Month 40), n=108	-0.030 Millimoles per liter Standard Deviation 0.2585
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 13 (Month 44), n=100	-0.026 Millimoles per liter Standard Deviation 0.2241
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 14 (Month 48), n=101	-0.050 Millimoles per liter Standard Deviation 0.2331
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 15 (Month 52), n=88	-0.054 Millimoles per liter Standard Deviation 0.2207
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 16 (Month 56), n=75	-0.052 Millimoles per liter Standard Deviation 0.2465
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 19 (Month 68), n=49	-0.047 Millimoles per liter Standard Deviation 0.2905
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 20 (Month 72), n=58	-0.076 Millimoles per liter Standard Deviation 0.2502
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 21 (Month 76), n=40	-0.074 Millimoles per liter Standard Deviation 0.2503
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 23 (Month 84), n=32	-0.068 Millimoles per liter Standard Deviation 0.3006
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 24 (Month 88), n=28	-0.115 Millimoles per liter Standard Deviation 0.3460
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 25 (Month 92), n=25	-0.130 Millimoles per liter Standard Deviation 0.3251
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 26 (Month 96), n=26	-0.098 Millimoles per liter Standard Deviation 0.2820
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 27 (Month 100), n=20	-0.197 Millimoles per liter Standard Deviation 0.3030
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 28 (Month 104), n=16	-0.261 Millimoles per liter Standard Deviation 0.2665
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 30 (Month 112), n=4	-0.065 Millimoles per liter Standard Deviation 0.0603
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 31 (Month 116), n=3	-0.260 Millimoles per liter Standard Deviation 0.0000
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Visit 32 (Month 120), n=1	-0.320 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Phosphorus, Follow up, n=260	-0.038 Millimoles per liter Standard Deviation 0.2237
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 1 (Month 1), n=351	-0.02 Millimoles per liter Standard Deviation 0.426
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 1a (Month 2), n=1	-0.40 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 2 (Month 3), n=322	-0.05 Millimoles per liter Standard Deviation 0.410
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 2a (Month 4), n=1	0.40 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 3 (Month 6), n=279	-0.04 Millimoles per liter Standard Deviation 0.424
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 4 (Month 9), n=247	-0.08 Millimoles per liter Standard Deviation 0.427
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 5 (Month 12), n=230	-0.07 Millimoles per liter Standard Deviation 0.440
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 6 (Month 16), n=199	0.00 Millimoles per liter Standard Deviation 0.436
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 7 (Month 20), n=174	-0.02 Millimoles per liter Standard Deviation 0.434
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 8 (Month 24), n=162	-0.03 Millimoles per liter Standard Deviation 0.430
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 9 (Month 28), n=143	-0.01 Millimoles per liter Standard Deviation 0.434
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 10 (Month 32), n=127	-0.01 Millimoles per liter Standard Deviation 0.451
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 11 (Month 36), n=116	-0.01 Millimoles per liter Standard Deviation 0.457
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 12 (Month 40), n=108	-0.05 Millimoles per liter Standard Deviation 0.475
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 13 (Month 44), n=102	-0.06 Millimoles per liter Standard Deviation 0.466
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 14 (Month 48), n=101	-0.01 Millimoles per liter Standard Deviation 0.443
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 17 (Month 60), n=89	-0.05 Millimoles per liter Standard Deviation 0.477
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 18 (Month 64), n=55	-0.12 Millimoles per liter Standard Deviation 0.468
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 19 (Month 68), n=50	-0.03 Millimoles per liter Standard Deviation 0.484
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 20 (Month 72), n=58	-0.10 Millimoles per liter Standard Deviation 0.485
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 21 (Month 76), n=39	-0.11 Millimoles per liter Standard Deviation 0.469
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 22 (Month 80), n=35	-0.08 Millimoles per liter Standard Deviation 0.461
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 23 (Month 84), n=32	0.01 Millimoles per liter Standard Deviation 0.523
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 24 (Month 88), n=28	-0.05 Millimoles per liter Standard Deviation 0.517
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 25 (Month 92), n=25	-0.01 Millimoles per liter Standard Deviation 0.488
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 26 (Month 96), n=26	-0.02 Millimoles per liter Standard Deviation 0.603
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 27 (Month 100), n=20	-0.09 Millimoles per liter Standard Deviation 0.609
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 28 (Month 104), n=16	-0.18 Millimoles per liter Standard Deviation 0.481
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 29 (Month 108), n=13	-0.09 Millimoles per liter Standard Deviation 0.647
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 30 (Month 112), n=4	-0.38 Millimoles per liter Standard Deviation 0.574
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Visit 31 (Month 116), n=3	-0.83 Millimoles per liter Standard Deviation 0.611
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Potassium, Follow up, n=258	-0.02 Millimoles per liter Standard Deviation 0.456
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 1 (Month 1), n=352	-0.3 Millimoles per liter Standard Deviation 3.60
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 1a (Month 2), n=1	0.0 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 2 (Month 3), n=324	-0.1 Millimoles per liter Standard Deviation 3.52
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 2a (Month 4), n=1	1.0 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 3 (Month 6), n=280	0.8 Millimoles per liter Standard Deviation 3.49
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 4 (Month 9), n=248	0.5 Millimoles per liter Standard Deviation 3.50
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 5 (Month 12), n=231	0.6 Millimoles per liter Standard Deviation 3.84
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 6 (Month 16), n=200	0.9 Millimoles per liter Standard Deviation 3.81
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 7 (Month 20), n=176	1.1 Millimoles per liter Standard Deviation 3.88
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 8 (Month 24), n=164	1.0 Millimoles per liter Standard Deviation 4.38
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 9 (Month 28), n=143	1.6 Millimoles per liter Standard Deviation 4.36
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 10 (Month 32), n=127	1.2 Millimoles per liter Standard Deviation 4.08
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 11 (Month 36), n=118	1.3 Millimoles per liter Standard Deviation 5.15
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 12 (Month 40), n=108	1.9 Millimoles per liter Standard Deviation 4.25
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 13 (Month 44), n=103	1.7 Millimoles per liter Standard Deviation 4.06
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 14 (Month 48), n=102	1.1 Millimoles per liter Standard Deviation 4.44
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 15 (Month 52), n=89	1.8 Millimoles per liter Standard Deviation 4.29
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 16 (Month 56), n=76	1.7 Millimoles per liter Standard Deviation 3.75
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 17 (Month 60), n=91	1.8 Millimoles per liter Standard Deviation 4.62
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 18 (Month 64), n=55	2.7 Millimoles per liter Standard Deviation 3.32
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 20 (Month 72), n=58	1.0 Millimoles per liter Standard Deviation 4.46
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 21 (Month 76), n=40	2.2 Millimoles per liter Standard Deviation 3.82
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 22 (Month 80), n=35	2.0 Millimoles per liter Standard Deviation 3.11
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 23 (Month 84), n=32	2.4 Millimoles per liter Standard Deviation 3.72
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 24 (Month 88), n=28	1.9 Millimoles per liter Standard Deviation 3.85
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 26 (Month 96), n=26	1.8 Millimoles per liter Standard Deviation 4.48
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 27 (Month 100), n=20	1.8 Millimoles per liter Standard Deviation 4.76
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 28 (Month 104), n=16	0.9 Millimoles per liter Standard Deviation 3.14
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 30 (Month 112), n=4	-0.3 Millimoles per liter Standard Deviation 5.85
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 31 (Month 116), n=3	0.7 Millimoles per liter Standard Deviation 3.79
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Visit 32 (Month 120), n=1	-5.0 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Sodium, Follow up, n=261	0.3 Millimoles per liter Standard Deviation 3.91
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 1 (Month 1), n=351	0.583 Millimoles per liter Standard Deviation 1.2933
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 2 (Month 3), n=322	0.606 Millimoles per liter Standard Deviation 1.2846
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 2a (Month 4), n=1	1.780 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 3 (Month 6), n=279	0.623 Millimoles per liter Standard Deviation 1.3294
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 4 (Month 9), n=248	0.642 Millimoles per liter Standard Deviation 1.3781
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 6 (Month 16), n=200	0.656 Millimoles per liter Standard Deviation 1.3598
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 7 (Month 20), n=176	0.750 Millimoles per liter Standard Deviation 1.3893
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 10 (Month 32), n=126	0.748 Millimoles per liter Standard Deviation 1.5680
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 11 (Month 36), n=117	0.552 Millimoles per liter Standard Deviation 1.6650
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 12 (Month 40), n=108	0.794 Millimoles per liter Standard Deviation 1.5456
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 13 (Month 44), n=102	0.697 Millimoles per liter Standard Deviation 1.5664
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 14 (Month 48), n=101	0.792 Millimoles per liter Standard Deviation 1.7321
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 15 (Month 52), n=88	0.828 Millimoles per liter Standard Deviation 1.4226
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 16 (Month 56), n=76	0.742 Millimoles per liter Standard Deviation 1.3964
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 17 (Month 60), n=90	0.778 Millimoles per liter Standard Deviation 1.5392
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 18 (Month 64), n=55	0.766 Millimoles per liter Standard Deviation 1.5980
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 19 (Month 68), n=51	0.791 Millimoles per liter Standard Deviation 1.3485
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 20 (Month 72), n=58	0.794 Millimoles per liter Standard Deviation 1.5895
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 21 (Month 76), n=40	1.152 Millimoles per liter Standard Deviation 1.3824
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 22 (Month 80), n=35	0.939 Millimoles per liter Standard Deviation 1.2432
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 23 (Month 84), n=32	0.781 Millimoles per liter Standard Deviation 1.3376
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 24 (Month 88), n=28	0.791 Millimoles per liter Standard Deviation 1.0485
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 25 (Month 92), n=25	0.529 Millimoles per liter Standard Deviation 1.6380
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 26 (Month 96), n=26	0.811 Millimoles per liter Standard Deviation 1.4025
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 27 (Month 100), n=20	0.501 Millimoles per liter Standard Deviation 1.1668
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 28 (Month 104), n=16	0.536 Millimoles per liter Standard Deviation 0.9589
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 29 (Month 108), n=13	0.523 Millimoles per liter Standard Deviation 1.2418
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 30 (Month 112), n=4	0.983 Millimoles per liter Standard Deviation 1.0297
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 31 (Month 116), n=3	0.837 Millimoles per liter Standard Deviation 1.6082
Change From Baseline in Bicarbonate, Calcium, Chloride, Cholesterol, Non-fasting Glucose, Phosphorus, Potassium, Sodium and Urea Urea, Visit 32 (Month 120), n=1	-1.070 Millimoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

Clinical chemistry parameters included creatinine, total bilirubin and uric acid. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 2a (Month 4), n=1	9.0 Micromoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 4 (Month 9), n=247	0.1 Micromoles per liter Standard Deviation 9.04
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 5 (Month 12), n=227	0.0 Micromoles per liter Standard Deviation 9.33
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 10 (Month 32), n=126	1.3 Micromoles per liter Standard Deviation 10.98
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 11 (Month 36), n=115	-0.3 Micromoles per liter Standard Deviation 10.13
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 17 (Month 60), n=89	-1.6 Micromoles per liter Standard Deviation 10.31
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 2 (Month 3), n=322	3.5 Micromoles per liter Standard Deviation 3.57
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 11 (Month 36), n=116	4.0 Micromoles per liter Standard Deviation 3.82
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 12 (Month 40), n=107	3.7 Micromoles per liter Standard Deviation 3.44
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 13 (Month 44), n=101	3.9 Micromoles per liter Standard Deviation 3.46
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 22 (Month 80), n=35	3.2 Micromoles per liter Standard Deviation 4.22
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 27 (Month 100), n=20	5.2 Micromoles per liter Standard Deviation 6.29
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 29 (Month 108), n=13	5.5 Micromoles per liter Standard Deviation 8.32
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 30 (Month 112), n=4	5.0 Micromoles per liter Standard Deviation 3.65
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 31 (Month 116), n=3	2.7 Micromoles per liter Standard Deviation 6.03
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 1a (Month 2), n=1	41.0 Micromoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 7 (Month 20), n=176	8.8 Micromoles per liter Standard Deviation 50.55
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 9 (Month 28), n=142	7.7 Micromoles per liter Standard Deviation 59.32
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 14 (Month 48), n=101	6.8 Micromoles per liter Standard Deviation 61.69
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 17 (Month 60), n=90	14.7 Micromoles per liter Standard Deviation 61.14
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 1 (Month 1), n=351	1.8 Micromoles per liter Standard Deviation 12.85
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 1a (Month 2), n=1	0.0 Micromoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 2 (Month 3), n=320	0.9 Micromoles per liter Standard Deviation 8.49
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 3 (Month 6), n=278	0.7 Micromoles per liter Standard Deviation 8.89
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 6 (Month 16), n=199	0.8 Micromoles per liter Standard Deviation 10.14
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 7 (Month 20), n=176	0.6 Micromoles per liter Standard Deviation 9.84
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 8 (Month 24), n=161	0.0 Micromoles per liter Standard Deviation 8.81
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 9 (Month 28), n=142	-0.2 Micromoles per liter Standard Deviation 9.98
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 12 (Month 40), n=108	0.8 Micromoles per liter Standard Deviation 10.30
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 13 (Month 44), n=101	0.5 Micromoles per liter Standard Deviation 10.70
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 14 (Month 48), n=101	-0.3 Micromoles per liter Standard Deviation 10.49
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 15 (Month 52), n=88	0.8 Micromoles per liter Standard Deviation 9.55
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 16 (Month 56), n=75	1.1 Micromoles per liter Standard Deviation 22.92
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 18 (Month 64), n=55	-0.7 Micromoles per liter Standard Deviation 11.09
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 19 (Month 68), n=50	-0.9 Micromoles per liter Standard Deviation 13.22
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 20 (Month 72), n=58	-3.6 Micromoles per liter Standard Deviation 11.31
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 21 (Month 76), n=40	-0.7 Micromoles per liter Standard Deviation 13.10
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 22 (Month 80), n=35	-2.2 Micromoles per liter Standard Deviation 11.98
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 23 (Month 84), n=32	-1.4 Micromoles per liter Standard Deviation 12.50
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 24 (Month 88), n=28	-4.1 Micromoles per liter Standard Deviation 12.03
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 25 (Month 92), n=25	-3.2 Micromoles per liter Standard Deviation 10.84
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 26 (Month 96), n=26	-2.6 Micromoles per liter Standard Deviation 13.67
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 27 (Month 100), n=20	-3.9 Micromoles per liter Standard Deviation 11.05
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 28 (Month 104), n=16	-4.2 Micromoles per liter Standard Deviation 10.63
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 29 (Month 108), n=13	-7.7 Micromoles per liter Standard Deviation 13.98
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 30 (Month 112), n=4	-6.3 Micromoles per liter Standard Deviation 6.85
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 31 (Month 116), n=3	-18.7 Micromoles per liter Standard Deviation 8.50
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Visit 32 (Month 120), n=1	-19.0 Micromoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Creatinine, Follow up, n=260	0.6 Micromoles per liter Standard Deviation 9.99
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 1 (Month 1), n=351	3.5 Micromoles per liter Standard Deviation 3.41
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 1a (Month 2), n=1	0.0 Micromoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 2a (Month 4), n=1	6.0 Micromoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 3 (Month 6), n=278	3.6 Micromoles per liter Standard Deviation 3.62
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 4 (Month 9), n=245	3.5 Micromoles per liter Standard Deviation 3.63
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 5 (Month 12), n=227	3.4 Micromoles per liter Standard Deviation 3.56
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 6 (Month 16), n=200	3.6 Micromoles per liter Standard Deviation 3.69
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 7 (Month 20), n=176	3.7 Micromoles per liter Standard Deviation 3.60
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 8 (Month 24), n=162	3.8 Micromoles per liter Standard Deviation 3.70
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 9 (Month 28), n=141	3.7 Micromoles per liter Standard Deviation 3.57
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 10 (Month 32), n=126	4.1 Micromoles per liter Standard Deviation 3.68
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 14 (Month 48), n=100	3.7 Micromoles per liter Standard Deviation 3.67
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 15 (Month 52), n=88	3.7 Micromoles per liter Standard Deviation 3.37
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 16 (Month 56), n=76	3.6 Micromoles per liter Standard Deviation 3.47
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 17 (Month 60), n=90	3.8 Micromoles per liter Standard Deviation 3.36
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 18 (Month 64), n=55	3.7 Micromoles per liter Standard Deviation 3.68
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 19 (Month 68), n=51	3.1 Micromoles per liter Standard Deviation 4.12
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 20 (Month 72), n=58	3.3 Micromoles per liter Standard Deviation 3.69
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 21 (Month 76), n=40	3.7 Micromoles per liter Standard Deviation 4.02
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 23 (Month 84), n=32	3.4 Micromoles per liter Standard Deviation 4.01
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 24 (Month 88), n=28	3.6 Micromoles per liter Standard Deviation 5.04
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 25 (Month 92), n=25	5.5 Micromoles per liter Standard Deviation 4.57
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 26 (Month 96), n=26	5.5 Micromoles per liter Standard Deviation 6.59
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 28 (Month 104), n=16	5.8 Micromoles per liter Standard Deviation 5.01
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Visit 32 (Month 120), n=1	11.0 Micromoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Total Bilirubin, Follow up, n=258	0.0 Micromoles per liter Standard Deviation 2.92
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 1 (Month 1), n=352	2.1 Micromoles per liter Standard Deviation 38.02
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 2 (Month 3), n=322	5.5 Micromoles per liter Standard Deviation 42.30
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 2a (Month 4), n=1	107.0 Micromoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 3 (Month 6), n=279	4.3 Micromoles per liter Standard Deviation 44.39
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 4 (Month 9), n=248	7.8 Micromoles per liter Standard Deviation 41.60
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 5 (Month 12), n=228	5.3 Micromoles per liter Standard Deviation 45.90
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 6 (Month 16), n=200	7.9 Micromoles per liter Standard Deviation 49.61
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 8 (Month 24), n=163	10.1 Micromoles per liter Standard Deviation 54.77
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 10 (Month 32), n=126	8.7 Micromoles per liter Standard Deviation 55.37
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 11 (Month 36), n=116	9.8 Micromoles per liter Standard Deviation 55.78
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 12 (Month 40), n=108	13.8 Micromoles per liter Standard Deviation 64.68
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 13 (Month 44), n=101	13.4 Micromoles per liter Standard Deviation 61.73
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 15 (Month 52), n=88	14.2 Micromoles per liter Standard Deviation 69.08
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 16 (Month 56), n=76	12.0 Micromoles per liter Standard Deviation 60.26
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 18 (Month 64), n=55	14.8 Micromoles per liter Standard Deviation 58.21
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 19 (Month 68), n=50	25.2 Micromoles per liter Standard Deviation 62.64
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 20 (Month 72), n=58	14.4 Micromoles per liter Standard Deviation 62.38
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 21 (Month 76), n=40	25.5 Micromoles per liter Standard Deviation 67.33
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 22 (Month 80), n=35	18.3 Micromoles per liter Standard Deviation 63.64
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 23 (Month 84), n=32	21.4 Micromoles per liter Standard Deviation 60.20
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 24 (Month 88), n=28	14.0 Micromoles per liter Standard Deviation 72.96
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 25 (Month 92), n=25	29.6 Micromoles per liter Standard Deviation 79.56
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 26 (Month 96), n=26	14.3 Micromoles per liter Standard Deviation 69.23
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 27 (Month 100), n=20	14.2 Micromoles per liter Standard Deviation 71.63
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 28 (Month 104), n=16	-1.8 Micromoles per liter Standard Deviation 59.67
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 29 (Month 108), n=13	9.2 Micromoles per liter Standard Deviation 74.02
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 30 (Month 112), n=4	46.3 Micromoles per liter Standard Deviation 87.78
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 31 (Month 116), n=3	-8.0 Micromoles per liter Standard Deviation 37.24
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Visit 32 (Month 120), n=1	-23.0 Micromoles per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed
Change From Baseline in Creatinine, Total Bilirubin and Uric Acid Uric acid, Follow up, n=261	11.7 Micromoles per liter Standard Deviation 45.09

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

Clinical chemistry parameter included total protein. The clinical laboratory evaluation were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Change From Baseline in Total Protein Total Protein, Visit 2 (Month 3), n=322	-0.8 Grams per liter Standard Deviation 4.34
Change From Baseline in Total Protein Total Protein, Visit 5 (Month 12), n=228	-1.6 Grams per liter Standard Deviation 4.34
Change From Baseline in Total Protein Total Protein, Visit 6 (Month 16), n=200	-1.3 Grams per liter Standard Deviation 4.24
Change From Baseline in Total Protein Total Protein, Visit 7 (Month 20), n=176	-1.8 Grams per liter Standard Deviation 4.19
Change From Baseline in Total Protein Total Protein, Visit 9 (Month 28), n=142	-1.5 Grams per liter Standard Deviation 4.22
Change From Baseline in Total Protein Total Protein, Visit 10 (Month 32), n=126	-1.3 Grams per liter Standard Deviation 4.62
Change From Baseline in Total Protein Total Protein, Visit 11 (Month 36), n=116	-2.1 Grams per liter Standard Deviation 4.35
Change From Baseline in Total Protein Total Protein, Visit 12 (Month 40), n=108	-1.9 Grams per liter Standard Deviation 4.36
Change From Baseline in Total Protein Total Protein, Visit 13 (Month 44), n=101	-1.8 Grams per liter Standard Deviation 4.10
Change From Baseline in Total Protein Total Protein, Visit 14 (Month 48), n=101	-2.0 Grams per liter Standard Deviation 4.37
Change From Baseline in Total Protein Total Protein, Visit 15 (Month 52), n=88	-1.9 Grams per liter Standard Deviation 4.81
Change From Baseline in Total Protein Total Protein, Visit 16 (Month 56), n=76	-2.1 Grams per liter Standard Deviation 4.18
Change From Baseline in Total Protein Total Protein, Visit 17 (Month 60), n=90	-2.4 Grams per liter Standard Deviation 4.29
Change From Baseline in Total Protein Total Protein, Visit 18 (Month 64), n=55	-2.2 Grams per liter Standard Deviation 4.12
Change From Baseline in Total Protein Total Protein, Visit 20 (Month 72), n=58	-3.0 Grams per liter Standard Deviation 4.85
Change From Baseline in Total Protein Total Protein, Visit 21 (Month 76), n=40	-1.8 Grams per liter Standard Deviation 4.01
Change From Baseline in Total Protein Total Protein, Visit 22 (Month 80), n=35	-0.6 Grams per liter Standard Deviation 5.09
Change From Baseline in Total Protein Total Protein, Visit 23 (Month 84), n=32	-2.2 Grams per liter Standard Deviation 4.38
Change From Baseline in Total Protein Total Protein, Visit 24 (Month 88), n=28	-1.9 Grams per liter Standard Deviation 4.63
Change From Baseline in Total Protein Total Protein, Visit 25 (Month 92), n=25	-1.2 Grams per liter Standard Deviation 4.82
Change From Baseline in Total Protein Total Protein, Visit 26 (Month 96), n=26	-1.1 Grams per liter Standard Deviation 5.32
Change From Baseline in Total Protein Total Protein, Visit 27 (Month 100), n=20	-0.9 Grams per liter Standard Deviation 4.08
Change From Baseline in Total Protein Total Protein, Visit 28 (Month 104), n=16	-0.2 Grams per liter Standard Deviation 4.68
Change From Baseline in Total Protein Total Protein, Visit 29 (Month 108), n=13	-2.1 Grams per liter Standard Deviation 4.57
Change From Baseline in Total Protein Total Protein, Visit 30 (Month 112), n=4	0.8 Grams per liter Standard Deviation 2.36
Change From Baseline in Total Protein Total Protein, Visit 31 (Month 116), n=3	-4.7 Grams per liter Standard Deviation 0.58
Change From Baseline in Total Protein Total Protein, Visit 32 (Month 120), n=1	-4.0 Grams per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Total Protein Total Protein, Follow up, n=261	-1.1 Grams per liter Standard Deviation 4.75
Change From Baseline in Total Protein Total Protein, Visit 1 (Month 1), n=352	-1.1 Grams per liter Standard Deviation 4.32
Change From Baseline in Total Protein Total Protein, Visit 1a (Month 2), n=1	-12.0 Grams per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Total Protein Total Protein, Visit 2a (Month 4), n=1	-3.0 Grams per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Total Protein Total Protein, Visit 3 (Month 6), n=279	-1.1 Grams per liter Standard Deviation 4.18
Change From Baseline in Total Protein Total Protein, Visit 4 (Month 9), n=248	-1.8 Grams per liter Standard Deviation 5.42
Change From Baseline in Total Protein Total Protein, Visit 8 (Month 24), n=163	-1.5 Grams per liter Standard Deviation 4.25
Change From Baseline in Total Protein Total Protein, Visit 19 (Month 68), n=50	-2.2 Grams per liter Standard Deviation 3.95

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

Hematology parameters included eosinophils, basophils lymphocytes, monocytes, neutrophils, platelet count , and WBC. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 4a (Month 10), n=111	0.003 10^9 cells per Liter Standard Deviation 0.0276
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 5 (Month 12), n=225	0.002 10^9 cells per Liter Standard Deviation 0.0188
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 6 (Month 16), n=198	0.002 10^9 cells per Liter Standard Deviation 0.0215
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 1 (Month 1), n=345	0.003 10^9 cells per Liter Standard Deviation 0.0261
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 1a (Month 2), n=64	0.013 10^9 cells per Liter Standard Deviation 0.0340
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 2 (Month 3), n=309	0.001 10^9 cells per Liter Standard Deviation 0.0251
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 3 (Month 6), n=273	0.003 10^9 cells per Liter Standard Deviation 0.0340
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 3a (Month 8), n=97	0.005 10^9 cells per Liter Standard Deviation 0.0300
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 7 (Month 20), n=173	0.003 10^9 cells per Liter Standard Deviation 0.0230
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 8 (Month 24), n=159	0.001 10^9 cells per Liter Standard Deviation 0.0205
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 9 (Month 28), n=139	0.005 10^9 cells per Liter Standard Deviation 0.0200
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 10 (Month 32), n=125	0.008 10^9 cells per Liter Standard Deviation 0.0229
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 11 (Month 36), n=112	0.005 10^9 cells per Liter Standard Deviation 0.0200
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 12 (Month 40), n=108	0.007 10^9 cells per Liter Standard Deviation 0.0253
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 13 (Month 44), n=98	0.002 10^9 cells per Liter Standard Deviation 0.0157
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 14 (Month 48), n=100	0.002 10^9 cells per Liter Standard Deviation 0.0201
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 15 (Month 52), n=88	0.005 10^9 cells per Liter Standard Deviation 0.0249
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 16 (Month 56), n=75	0.006 10^9 cells per Liter Standard Deviation 0.0245
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 19 (Month 68), n=50	0.006 10^9 cells per Liter Standard Deviation 0.0184
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 21 (Month 76), n=39	0.009 10^9 cells per Liter Standard Deviation 0.0226
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 22 (Month 80), n=35	0.004 10^9 cells per Liter Standard Deviation 0.0140
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 23 (Month 84), n=32	0.009 10^9 cells per Liter Standard Deviation 0.0178
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 24 (Month 88), n=27	0.004 10^9 cells per Liter Standard Deviation 0.0189
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 25 (Month 92), n=25	0.013 10^9 cells per Liter Standard Deviation 0.0281
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 26 (Month 96), n=24	0.010 10^9 cells per Liter Standard Deviation 0.0254
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 27 (Month 100), n=20	0.010 10^9 cells per Liter Standard Deviation 0.0192
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 28 (Month 104), n=16	0.008 10^9 cells per Liter Standard Deviation 0.0118
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 29 (Month 108), n=13	0.005 10^9 cells per Liter Standard Deviation 0.0156
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 30 (Month 112), n=4	0.003 10^9 cells per Liter Standard Deviation 0.0171
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 31 (Month 116), n=3	-0.003 10^9 cells per Liter Standard Deviation 0.0153
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 32 (Month 120), n=1	-0.020 10^9 cells per Liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Follow up, n=252	0.001 10^9 cells per Liter Standard Deviation 0.0236
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 1 (Month 1), n=345	-0.006 10^9 cells per Liter Standard Deviation 0.1045
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 2 (Month 3), n=309	-0.006 10^9 cells per Liter Standard Deviation 0.1061
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 2a (Month 4), n=82	-0.002 10^9 cells per Liter Standard Deviation 0.1274
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 3 (Month 6), n=273	-0.009 10^9 cells per Liter Standard Deviation 0.0941
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 4 (Month 9), n=239	0.001 10^9 cells per Liter Standard Deviation 0.1148
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 4a (Month 10), n=111	-0.003 10^9 cells per Liter Standard Deviation 0.1126
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 5 (Month 12), n=225	-0.005 10^9 cells per Liter Standard Deviation 0.1160
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 6 (Month 16), n=198	-0.012 10^9 cells per Liter Standard Deviation 0.1015
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 7 (Month 20), n=173	-0.008 10^9 cells per Liter Standard Deviation 0.1070
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 8 (Month 24), n=159	-0.007 10^9 cells per Liter Standard Deviation 0.0989
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 9 (Month 28), n=139	-0.013 10^9 cells per Liter Standard Deviation 0.0972
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 10 (Month 32), n=125	-0.007 10^9 cells per Liter Standard Deviation 0.0997
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 12 (Month 40), n=108	-0.006 10^9 cells per Liter Standard Deviation 0.1044
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 13 (Month 44), n=98	-0.007 10^9 cells per Liter Standard Deviation 0.0962
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 14 (Month 48), n=100	-0.018 10^9 cells per Liter Standard Deviation 0.0973
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 15 (Month 52), n=88	-0.008 10^9 cells per Liter Standard Deviation 0.1115
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 16 (Month 56), n=75	-0.008 10^9 cells per Liter Standard Deviation 0.1051
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 17 (Month 60), n=88	0.009 10^9 cells per Liter Standard Deviation 0.1214
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 18 (Month 64), n=51	-0.001 10^9 cells per Liter Standard Deviation 0.1298
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 19 (Month 68), n=50	-0.008 10^9 cells per Liter Standard Deviation 0.1335
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 20 (Month 72), n=54	-0.002 10^9 cells per Liter Standard Deviation 0.1235
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 22 (Month 80), n=35	0.000 10^9 cells per Liter Standard Deviation 0.1352
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 23 (Month 84), n=32	0.015 10^9 cells per Liter Standard Deviation 0.1251
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 26 (Month 96), n=24	-0.007 10^9 cells per Liter Standard Deviation 0.1082
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 27 (Month 100), n=20	0.032 10^9 cells per Liter Standard Deviation 0.1637
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 28 (Month 104), n=16	0.041 10^9 cells per Liter Standard Deviation 0.1509
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 30 (Month 112), n=4	0.185 10^9 cells per Liter Standard Deviation 0.1933
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Follow up, n=252	-0.010 10^9 cells per Liter Standard Deviation 0.1082
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 1 (Month 1), n=345	-0.127 10^9 cells per Liter Standard Deviation 0.4854
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 1a (Month 2), n=64	-0.029 10^9 cells per Liter Standard Deviation 0.5459
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 2a (Month 4), n=82	-0.089 10^9 cells per Liter Standard Deviation 0.5561
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 4 (Month 9), n=239	-0.137 10^9 cells per Liter Standard Deviation 0.4833
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 4a (Month 10), n=111	0.007 10^9 cells per Liter Standard Deviation 0.4505
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 5 (Month 12), n=225	-0.118 10^9 cells per Liter Standard Deviation 0.4839
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 6 (Month 16), n=198	-0.130 10^9 cells per Liter Standard Deviation 0.4605
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 7 (Month 20), n=173	-0.103 10^9 cells per Liter Standard Deviation 0.4656
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 8 (Month 24), n=159	-0.091 10^9 cells per Liter Standard Deviation 0.4387
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 9 (Month 28), n=139	-0.099 10^9 cells per Liter Standard Deviation 0.4582
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 10 (Month 32), n=125	-0.103 10^9 cells per Liter Standard Deviation 0.4502
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 12 (Month 40), n=108	-0.114 10^9 cells per Liter Standard Deviation 0.5521
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 14 (Month 48), n=100	-0.117 10^9 cells per Liter Standard Deviation 0.4672
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 15 (Month 52), n=88	-0.055 10^9 cells per Liter Standard Deviation 0.4918
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 16 (Month 56), n=75	-0.049 10^9 cells per Liter Standard Deviation 0.5077
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 18 (Month 64), n=51	0.004 10^9 cells per Liter Standard Deviation 0.5778
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 19 (Month 68), n=50	0.077 10^9 cells per Liter Standard Deviation 0.5280
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 20 (Month 72), n=54	0.000 10^9 cells per Liter Standard Deviation 0.5129
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 22 (Month 80), n=35	0.110 10^9 cells per Liter Standard Deviation 0.5896
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 23 (Month 84), n=32	0.166 10^9 cells per Liter Standard Deviation 0.4766
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 24 (Month 88), n=27	0.133 10^9 cells per Liter Standard Deviation 0.5958
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 25 (Month 92), n=25	0.144 10^9 cells per Liter Standard Deviation 0.3940
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 26 (Month 96), n=24	-0.001 10^9 cells per Liter Standard Deviation 0.6195
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 27 (Month 100), n=20	0.172 10^9 cells per Liter Standard Deviation 0.5272
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 28 (Month 104), n=16	0.141 10^9 cells per Liter Standard Deviation 0.5226
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 29 (Month 108), n=13	0.193 10^9 cells per Liter Standard Deviation 0.5144
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 30 (Month 112), n=4	0.278 10^9 cells per Liter Standard Deviation 0.8945
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 31 (Month 116), n=3	0.367 10^9 cells per Liter Standard Deviation 0.4038
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 32 (Month 120), n=1	-0.130 10^9 cells per Liter Standard Deviation NA : Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Follow up, n=252	0.022 10^9 cells per Liter Standard Deviation 0.5031
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 1 (Month 1), n=345	0.024 10^9 cells per Liter Standard Deviation 0.1425
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 2 (Month 3), n=309	0.017 10^9 cells per Liter Standard Deviation 0.1580
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 4 (Month 9), n=239	0.022 10^9 cells per Liter Standard Deviation 0.1518
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 4a (Month 10), n=111	0.080 10^9 cells per Liter Standard Deviation 0.1653
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 5 (Month 12), n=225	0.028 10^9 cells per Liter Standard Deviation 0.1563
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 7 (Month 20), n=173	0.019 10^9 cells per Liter Standard Deviation 0.1661
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 8 (Month 24), n=159	0.038 10^9 cells per Liter Standard Deviation 0.1840
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 9 (Month 28), n=139	0.056 10^9 cells per Liter Standard Deviation 0.1646
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 11 (Month 36), n=112	0.049 10^9 cells per Liter Standard Deviation 0.1649
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 12 (Month 40), n=108	0.040 10^9 cells per Liter Standard Deviation 0.1750
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 13 (Month 44), n=98	0.037 10^9 cells per Liter Standard Deviation 0.1780
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 14 (Month 48), n=100	0.033 10^9 cells per Liter Standard Deviation 0.1442
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 16 (Month 56), n=75	0.043 10^9 cells per Liter Standard Deviation 0.1632
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 17 (Month 60), n=88	0.044 10^9 cells per Liter Standard Deviation 0.1736
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 18 (Month 64), n=51	0.028 10^9 cells per Liter Standard Deviation 0.1644
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 19 (Month 68), n=50	0.027 10^9 cells per Liter Standard Deviation 0.1253
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 21 (Month 76), n=39	0.078 10^9 cells per Liter Standard Deviation 0.2002
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 22 (Month 80), n=35	0.046 10^9 cells per Liter Standard Deviation 0.1629
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 23 (Month 84), n=32	0.064 10^9 cells per Liter Standard Deviation 0.1596
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 24 (Month 88), n=27	0.065 10^9 cells per Liter Standard Deviation 0.2083
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 25 (Month 92), n=25	0.057 10^9 cells per Liter Standard Deviation 0.1956
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 26 (Month 96), n=24	0.035 10^9 cells per Liter Standard Deviation 0.1405
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 27 (Month 100), n=20	0.119 10^9 cells per Liter Standard Deviation 0.1604
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 28 (Month 104), n=16	0.039 10^9 cells per Liter Standard Deviation 0.1903
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 29 (Month 108), n=13	0.068 10^9 cells per Liter Standard Deviation 0.2342
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 30 (Month 112), n=4	0.030 10^9 cells per Liter Standard Deviation 0.1985
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 31 (Month 116), n=3	-0.007 10^9 cells per Liter Standard Deviation 0.0850
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Follow up, n=252	0.022 10^9 cells per Liter Standard Deviation 0.1754
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 1 (Month 1), n=345	-0.143 10^9 cells per Liter Standard Deviation 1.3093
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 1a (Month 2), n=64	-0.142 10^9 cells per Liter Standard Deviation 1.3123
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 2 (Month 3), n=309	-0.045 10^9 cells per Liter Standard Deviation 1.1768
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 3 (Month 6), n=273	-0.087 10^9 cells per Liter Standard Deviation 1.3700
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 4 (Month 9), n=239	0.032 10^9 cells per Liter Standard Deviation 1.1933
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 4a (Month 10), n=111	0.203 10^9 cells per Liter Standard Deviation 1.3922
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 6 (Month 16), n=198	0.086 10^9 cells per Liter Standard Deviation 1.3107
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 7 (Month 20), n=173	0.121 10^9 cells per Liter Standard Deviation 1.2780
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 8 (Month 24), n=159	0.368 10^9 cells per Liter Standard Deviation 1.4584
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 10 (Month 32), n=125	0.118 10^9 cells per Liter Standard Deviation 1.1824
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 11 (Month 36), n=112	0.057 10^9 cells per Liter Standard Deviation 1.2868
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 12 (Month 40), n=108	0.196 10^9 cells per Liter Standard Deviation 1.1770
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 13 (Month 44), n=98	0.243 10^9 cells per Liter Standard Deviation 1.4180
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 14 (Month 48), n=100	0.095 10^9 cells per Liter Standard Deviation 1.2410
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 15 (Month 52), n=88	0.432 10^9 cells per Liter Standard Deviation 1.4504
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 16 (Month 56), n=75	0.412 10^9 cells per Liter Standard Deviation 1.4045
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 17 (Month 60), n=88	0.416 10^9 cells per Liter Standard Deviation 1.3905
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 18 (Month 64), n=51	0.296 10^9 cells per Liter Standard Deviation 1.2674
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 20 (Month 72), n=54	0.552 10^9 cells per Liter Standard Deviation 1.3322
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 27 (Month 100), n=20	0.247 10^9 cells per Liter Standard Deviation 1.6045
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 28 (Month 104), n=16	0.458 10^9 cells per Liter Standard Deviation 1.1406
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 29 (Month 108), n=13	-0.027 10^9 cells per Liter Standard Deviation 1.4607
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 30 (Month 112), n=4	0.658 10^9 cells per Liter Standard Deviation 1.2219
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 32 (Month 120), n=1	0.470 10^9 cells per Liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Follow up, n=252	-0.010 10^9 cells per Liter Standard Deviation 1.5258
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet Count, Visit 1 (Month 1), n=345	0.9 10^9 cells per Liter Standard Deviation 40.69
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 1a (Month 2), n=65	6.4 10^9 cells per Liter Standard Deviation 41.67
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 2 (Month 3), n=311	0.7 10^9 cells per Liter Standard Deviation 37.59
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 3 (Month 6), n=273	-1.7 10^9 cells per Liter Standard Deviation 41.28
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 3a (Month 8), n=99	-5.3 10^9 cells per Liter Standard Deviation 31.49
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 4 (Month 9), n=241	-7.1 10^9 cells per Liter Standard Deviation 37.88
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 4a (Month 10), n=108	-2.8 10^9 cells per Liter Standard Deviation 38.71
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 5 (Month 12), n=225	-8.6 10^9 cells per Liter Standard Deviation 35.57
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 6 (Month 16), n=196	-9.0 10^9 cells per Liter Standard Deviation 43.09
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 7 (Month 20), n=171	-15.8 10^9 cells per Liter Standard Deviation 41.13
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 8 (Month 24), n=162	-17.3 10^9 cells per Liter Standard Deviation 44.99
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 9 (Month 28), n=137	-18.0 10^9 cells per Liter Standard Deviation 44.47
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 10 (Month 32), n=124	-20.8 10^9 cells per Liter Standard Deviation 38.96
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 11 (Month 36), n=114	-25.8 10^9 cells per Liter Standard Deviation 42.66
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 12 (Month 40), n=108	-24.3 10^9 cells per Liter Standard Deviation 39.96
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 14 (Month 48), n=98	-25.2 10^9 cells per Liter Standard Deviation 37.88
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 16 (Month 56), n=75	-17.1 10^9 cells per Liter Standard Deviation 50.19
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 17 (Month 60), n=88	-18.6 10^9 cells per Liter Standard Deviation 46.11
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 18 (Month 64), n=54	-23.1 10^9 cells per Liter Standard Deviation 38.78
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 19 (Month 68), n=50	-17.7 10^9 cells per Liter Standard Deviation 42.66
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 21 (Month 76), n=40	-11.1 10^9 cells per Liter Standard Deviation 55.97
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 22 (Month 80), n=34	-10.0 10^9 cells per Liter Standard Deviation 57.22
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 23 (Month 84), n=31	-7.0 10^9 cells per Liter Standard Deviation 50.20
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 24 (Month 88), n=25	-22.1 10^9 cells per Liter Standard Deviation 29.77
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 25 (Month 92), n=25	-16.8 10^9 cells per Liter Standard Deviation 40.54
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 26 (Month 96), n=24	-4.9 10^9 cells per Liter Standard Deviation 43.76
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 27 (Month 100), n=20	1.9 10^9 cells per Liter Standard Deviation 45.98
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 28 (Month 104), n=16	-6.3 10^9 cells per Liter Standard Deviation 44.81
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 29 (Month 108), n=13	-9.5 10^9 cells per Liter Standard Deviation 41.54
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 30 (Month 112), n=4	10.0 10^9 cells per Liter Standard Deviation 32.44
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 31 (Month 116), n=3	-5.7 10^9 cells per Liter Standard Deviation 30.09
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 32 (Month 120), n=1	25.0 10^9 cells per Liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Follow up, n=249	-9.4 10^9 cells per Liter Standard Deviation 49.63
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 1 (Month 1), n=349	-0.25 10^9 cells per Liter Standard Deviation 1.403
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 1a (Month 2), n=65	-0.11 10^9 cells per Liter Standard Deviation 1.478
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 2 (Month 3), n=315	-0.22 10^9 cells per Liter Standard Deviation 1.371
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 3a (Month 8), n=99	-0.15 10^9 cells per Liter Standard Deviation 1.537
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 4 (Month 9), n=244	-0.08 10^9 cells per Liter Standard Deviation 1.356
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 5 (Month 12), n=226	-0.09 10^9 cells per Liter Standard Deviation 1.690
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 6 (Month 16), n=199	-0.06 10^9 cells per Liter Standard Deviation 1.385
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 7 (Month 20), n=174	0.01 10^9 cells per Liter Standard Deviation 1.468
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 8 (Month 24), n=164	0.25 10^9 cells per Liter Standard Deviation 1.655
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 9 (Month 28), n=142	0.10 10^9 cells per Liter Standard Deviation 1.367
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 10 (Month 32), n=126	0.09 10^9 cells per Liter Standard Deviation 1.374
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 13 (Month 44), n=98	0.21 10^9 cells per Liter Standard Deviation 1.687
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 14 (Month 48), n=101	-0.01 10^9 cells per Liter Standard Deviation 1.381
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 16 (Month 56), n=76	0.37 10^9 cells per Liter Standard Deviation 1.603
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 17 (Month 60), n=89	0.41 10^9 cells per Liter Standard Deviation 1.663
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 18 (Month 64), n=54	0.33 10^9 cells per Liter Standard Deviation 1.613
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 19 (Month 68), n=50	0.54 10^9 cells per Liter Standard Deviation 1.376
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 21 (Month 76), n=40	0.81 10^9 cells per Liter Standard Deviation 1.940
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 22 (Month 80), n=35	0.52 10^9 cells per Liter Standard Deviation 1.622
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 23 (Month 84), n=32	0.83 10^9 cells per Liter Standard Deviation 1.599
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 24 (Month 88), n=27	0.57 10^9 cells per Liter Standard Deviation 1.964
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 25 (Month 92), n=25	0.34 10^9 cells per Liter Standard Deviation 2.114
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 26 (Month 96), n=24	0.75 10^9 cells per Liter Standard Deviation 1.670
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 27 (Month 100), n=20	0.59 10^9 cells per Liter Standard Deviation 1.809
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 28 (Month 104), n=16	0.70 10^9 cells per Liter Standard Deviation 1.372
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 29 (Month 108), n=13	0.30 10^9 cells per Liter Standard Deviation 1.614
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 30 (Month 112), n=4	1.18 10^9 cells per Liter Standard Deviation 1.864
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 31 (Month 116), n=3	0.70 10^9 cells per Liter Standard Deviation 0.800
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 32 (Month 120), n=1	0.40 10^9 cells per Liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Follow up, n=255	0.02 10^9 cells per Liter Standard Deviation 1.738
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 20 (Month 72), n=54	0.039 10^9 cells per Liter Standard Deviation 0.1201
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 32 (Month 120), n=1	0.080 10^9 cells per Liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 2a (Month 4), n=82	0.075 10^9 cells per Liter Standard Deviation 1.4826
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 3a (Month 8), n=97	-0.098 10^9 cells per Liter Standard Deviation 1.3412
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 5 (Month 12), n=225	0.015 10^9 cells per Liter Standard Deviation 1.6014
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 9 (Month 28), n=139	0.188 10^9 cells per Liter Standard Deviation 1.2575
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 19 (Month 68), n=50	0.436 10^9 cells per Liter Standard Deviation 1.0379
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 21 (Month 76), n=39	0.639 10^9 cells per Liter Standard Deviation 1.5548
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 22 (Month 80), n=35	0.346 10^9 cells per Liter Standard Deviation 1.3809
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 23 (Month 84), n=32	0.560 10^9 cells per Liter Standard Deviation 1.4536
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 24 (Month 88), n=27	0.366 10^9 cells per Liter Standard Deviation 1.8672
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 25 (Month 92), n=25	0.130 10^9 cells per Liter Standard Deviation 1.9387
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 26 (Month 96), n=24	0.707 10^9 cells per Liter Standard Deviation 1.7085
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 2a (Month 4), n=82	0.021 10^9 cells per Liter Standard Deviation 0.0488
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Neutrophils, Visit 31 (Month 116), n=3	0.297 10^9 cells per Liter Standard Deviation 0.5320
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 4 (Month 9), n=239	0.000 10^9 cells per Liter Standard Deviation 0.0222
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 2a (Month 4), n=82	12.7 10^9 cells per Liter Standard Deviation 37.26
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 13 (Month 44), n=98	-22.4 10^9 cells per Liter Standard Deviation 37.92
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 17 (Month 60), n=89	0.006 10^9 cells per Liter Standard Deviation 0.0186
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 15 (Month 52), n=84	-22.3 10^9 cells per Liter Standard Deviation 40.93
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 18 (Month 64), n=51	0.005 10^9 cells per Liter Standard Deviation 0.0334
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Platelet count, Visit 20 (Month 72), n=53	-20.4 10^9 cells per Liter Standard Deviation 51.90
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Basophils, Visit 20 (Month 72), n=54	0.005 10^9 cells per Liter Standard Deviation 0.0173
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 1a (Month 2), n=64	-0.018 10^9 cells per Liter Standard Deviation 0.0982
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 3a (Month 8), n=97	-0.010 10^9 cells per Liter Standard Deviation 0.1142
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 11 (Month 36), n=112	-0.004 10^9 cells per Liter Standard Deviation 0.1042
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 21 (Month 76), n=39	0.000 10^9 cells per Liter Standard Deviation 0.1365
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 24 (Month 88), n=27	-0.022 10^9 cells per Liter Standard Deviation 0.1272
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 25 (Month 92), n=25	-0.004 10^9 cells per Liter Standard Deviation 0.1064
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 29 (Month 108), n=13	0.062 10^9 cells per Liter Standard Deviation 0.1678
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 31 (Month 116), n=3	0.043 10^9 cells per Liter Standard Deviation 0.0603
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Eosinophils, Visit 32 (Month 120), n=1	-0.020 10^9 cells per Liter Standard Deviation NA : Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 2a (Month 4), n=82	0.07 10^9 cells per Liter Standard Deviation 1.648
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 3 (Month 6), n=278	-0.20 10^9 cells per Liter Standard Deviation 1.531
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 4a (Month 10), n=113	0.28 10^9 cells per Liter Standard Deviation 1.608
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 11 (Month 36), n=115	-0.05 10^9 cells per Liter Standard Deviation 1.387
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 12 (Month 40), n=109	0.10 10^9 cells per Liter Standard Deviation 1.514
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 15 (Month 52), n=88	0.43 10^9 cells per Liter Standard Deviation 1.648
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) WBC, Visit 20 (Month 72), n=55	0.57 10^9 cells per Liter Standard Deviation 1.532
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 2 (Month 3), n=309	-0.147 10^9 cells per Liter Standard Deviation 0.4446
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 3 (Month 6), n=273	-0.124 10^9 cells per Liter Standard Deviation 0.4476
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 3a (Month 8), n=97	-0.104 10^9 cells per Liter Standard Deviation 0.4733
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 11 (Month 36), n=112	-0.135 10^9 cells per Liter Standard Deviation 0.4232
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 13 (Month 44), n=98	-0.057 10^9 cells per Liter Standard Deviation 0.4896
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 17 (Month 60), n=88	-0.034 10^9 cells per Liter Standard Deviation 0.5568
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Lymphocytes, Visit 21 (Month 76), n=39	0.113 10^9 cells per Liter Standard Deviation 0.5493
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 1a (Month 2), n=64	0.085 10^9 cells per Liter Standard Deviation 0.1846
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 2a (Month 4), n=82	0.071 10^9 cells per Liter Standard Deviation 0.1850
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 3 (Month 6), n=273	0.022 10^9 cells per Liter Standard Deviation 0.1610
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 3a (Month 8), n=97	0.073 10^9 cells per Liter Standard Deviation 0.1581
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 6 (Month 16), n=198	0.023 10^9 cells per Liter Standard Deviation 0.1598
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 10 (Month 32), n=125	0.047 10^9 cells per Liter Standard Deviation 0.1597
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, White Blood Cells (WBC) Monocytes, Visit 15 (Month 52), n=88	0.065 10^9 cells per Liter Standard Deviation 0.1720

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

Blood samples for the assessment of clinical laboratory parameter hematocrit were collected at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Change From Baseline in Hematocrit Hematocrit, Visit 1 (Month 1), n=340	-0.009 Percentage of red blood cells in blood Standard Deviation 0.0215
Change From Baseline in Hematocrit Hematocrit, Visit 1a (Month 2), n=63	-0.005 Percentage of red blood cells in blood Standard Deviation 0.0227
Change From Baseline in Hematocrit Hematocrit, Visit 2 (Month 3), n=308	-0.004 Percentage of red blood cells in blood Standard Deviation 0.0229
Change From Baseline in Hematocrit Hematocrit, Visit 2a (Month 4), n=79	-0.012 Percentage of red blood cells in blood Standard Deviation 0.0230
Change From Baseline in Hematocrit Hematocrit, Visit 3 (Month 6), n=274	-0.005 Percentage of red blood cells in blood Standard Deviation 0.0244
Change From Baseline in Hematocrit Hematocrit, Visit 3a (Month 8), n=95	-0.009 Percentage of red blood cells in blood Standard Deviation 0.0264
Change From Baseline in Hematocrit Hematocrit, Visit 4 (Month 9), n=231	-0.002 Percentage of red blood cells in blood Standard Deviation 0.0263
Change From Baseline in Hematocrit Hematocrit, Visit 6 (Month 16), n=196	-0.003 Percentage of red blood cells in blood Standard Deviation 0.0270
Change From Baseline in Hematocrit Hematocrit, Visit 7 (Month 20), n=166	-0.001 Percentage of red blood cells in blood Standard Deviation 0.0255
Change From Baseline in Hematocrit Hematocrit, Visit 8 (Month 24), n=160	0.000 Percentage of red blood cells in blood Standard Deviation 0.0275
Change From Baseline in Hematocrit Hematocrit, Visit 9 (Month 28), n=141	0.005 Percentage of red blood cells in blood Standard Deviation 0.0260
Change From Baseline in Hematocrit Hematocrit, Visit 10 (Month 32), n=122	0.004 Percentage of red blood cells in blood Standard Deviation 0.0285
Change From Baseline in Hematocrit Hematocrit, Visit 11 (Month 36), n=113	-0.001 Percentage of red blood cells in blood Standard Deviation 0.0301
Change From Baseline in Hematocrit Haematocrit, Visit 12 (Month 40), n=106	0.006 Percentage of red blood cells in blood Standard Deviation 0.0301
Change From Baseline in Hematocrit Hematocrit, Visit 13 (Month 44), n=95	0.003 Percentage of red blood cells in blood Standard Deviation 0.0274
Change From Baseline in Hematocrit Hematocrit, Visit 14 (Month 48), n=100	-0.003 Percentage of red blood cells in blood Standard Deviation 0.0286
Change From Baseline in Hematocrit Hematocrit, Visit 15 (Month 52), n=88	-0.001 Percentage of red blood cells in blood Standard Deviation 0.0289
Change From Baseline in Hematocrit Hematocrit, Visit 16 (Month 56), n=74	-0.001 Percentage of red blood cells in blood Standard Deviation 0.0230
Change From Baseline in Hematocrit Haematocrit, Visit 17 (Month 60), n=88	0.000 Percentage of red blood cells in blood Standard Deviation 0.0314
Change From Baseline in Hematocrit Hematocrit, Visit 18 (Month 64), n=51	0.009 Percentage of red blood cells in blood Standard Deviation 0.0270
Change From Baseline in Hematocrit Hematocrit, Visit 19 (Month 68), n=50	0.008 Percentage of red blood cells in blood Standard Deviation 0.0278
Change From Baseline in Hematocrit Hematocrit, Visit 20 (Month 72), n=55	0.004 Percentage of red blood cells in blood Standard Deviation 0.0287
Change From Baseline in Hematocrit Hematocrit, Visit 21 (Month 76), n=39	0.010 Percentage of red blood cells in blood Standard Deviation 0.0377
Change From Baseline in Hematocrit Hematocrit, Visit 22 (Month 80), n=34	0.015 Percentage of red blood cells in blood Standard Deviation 0.0303
Change From Baseline in Hematocrit Hematocrit, Visit 23 (Month 84), n=30	0.000 Percentage of red blood cells in blood Standard Deviation 0.0344
Change From Baseline in Hematocrit Hematocrit, Visit 24 (Month 88), n=26	0.005 Percentage of red blood cells in blood Standard Deviation 0.0294
Change From Baseline in Hematocrit Hematocrit, Visit 25 (Month 92), n=24	0.016 Percentage of red blood cells in blood Standard Deviation 0.0264
Change From Baseline in Hematocrit Hematocrit, Visit 26 (Month 96), n=24	0.013 Percentage of red blood cells in blood Standard Deviation 0.0258
Change From Baseline in Hematocrit Hematocrit, Visit 27 (Month 100), n=20	0.016 Percentage of red blood cells in blood Standard Deviation 0.0201
Change From Baseline in Hematocrit Hematocrit, Visit 28 (Month 104), n=16	0.016 Percentage of red blood cells in blood Standard Deviation 0.0203
Change From Baseline in Hematocrit Hematocrit, Visit 31 (Month 116), n=3	0.033 Percentage of red blood cells in blood Standard Deviation 0.0666
Change From Baseline in Hematocrit Hematocrit, Visit 32 (Month 120), n=1	0.080 Percentage of red blood cells in blood Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Hematocrit Hematocrit,Follow up, n=253	0.003 Percentage of red blood cells in blood Standard Deviation 0.0262
Change From Baseline in Hematocrit Hematocrit, Visit 4a (Month 10), n=111	-0.004 Percentage of red blood cells in blood Standard Deviation 0.0254
Change From Baseline in Hematocrit Hematocrit, Visit 5 (Month 12), n=223	-0.004 Percentage of red blood cells in blood Standard Deviation 0.0256
Change From Baseline in Hematocrit Hematocrit, Visit 29 (Month 108), n=13	-0.002 Percentage of red blood cells in blood Standard Deviation 0.0268
Change From Baseline in Hematocrit Hematocrit, Visit 30 (Month 112), n=4	0.000 Percentage of red blood cells in blood Standard Deviation 0.0365

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

The hematology parameters included hemoglobin. The clinical laboratory evaluations were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Change From Baseline in Hemoglobin Hemoglobin, Visit 1 (Month 1), n=349	-2.6 Grams per liter Standard Deviation 6.96
Change From Baseline in Hemoglobin Hemoglobin, Visit 1a (Month 2), n=65	-1.8 Grams per liter Standard Deviation 7.30
Change From Baseline in Hemoglobin Hemoglobin, Visit 2a (Month 4), n=82	-3.3 Grams per liter Standard Deviation 8.11
Change From Baseline in Hemoglobin Hemoglobin, Visit 5 (Month 12), n=226	-1.4 Grams per liter Standard Deviation 8.64
Change From Baseline in Hemoglobin Hemoglobin, Visit 6 (Month 16), n=199	-0.4 Grams per liter Standard Deviation 8.83
Change From Baseline in Hemoglobin Hemoglobin, Visit 7 (Month 20), n=174	-0.6 Grams per liter Standard Deviation 9.01
Change From Baseline in Hemoglobin Hemoglobin, Visit 8 (Month 24), n=164	-0.3 Grams per liter Standard Deviation 8.58
Change From Baseline in Hemoglobin Hemoglobin, Visit 9 (Month 28), n=142	1.2 Grams per liter Standard Deviation 8.99
Change From Baseline in Hemoglobin Hemoglobin, Visit 10 (Month 32), n=126	0.3 Grams per liter Standard Deviation 9.58
Change From Baseline in Hemoglobin Hemoglobin, Visit 11 (Month 36), n=115	-1.0 Grams per liter Standard Deviation 10.12
Change From Baseline in Hemoglobin Hemoglobin, Visit 12 (Month 40), n=109	0.4 Grams per liter Standard Deviation 9.78
Change From Baseline in Hemoglobin Hemoglobin, Visit 13 (Month 44), n=98	-0.1 Grams per liter Standard Deviation 9.44
Change From Baseline in Hemoglobin Hemoglobin, Visit 14 (Month 48), n=101	-1.6 Grams per liter Standard Deviation 9.57
Change From Baseline in Hemoglobin Hemoglobin, Visit 15 (Month 52), n=88	-1.6 Grams per liter Standard Deviation 9.75
Change From Baseline in Hemoglobin Hemoglobin, Visit 16 (Month 56), n=76	-2.3 Grams per liter Standard Deviation 7.47
Change From Baseline in Hemoglobin Hemoglobin, Visit 17 (Month 60), n=89	-2.4 Grams per liter Standard Deviation 10.14
Change From Baseline in Hemoglobin Hemoglobin, Visit 18 (Month 64), n=54	-1.1 Grams per liter Standard Deviation 8.76
Change From Baseline in Hemoglobin Hemoglobin, Visit 19 (Month 68), n=50	-0.4 Grams per liter Standard Deviation 9.42
Change From Baseline in Hemoglobin Hemoglobin, Visit 20 (Month 72), n=55	-2.5 Grams per liter Standard Deviation 10.78
Change From Baseline in Hemoglobin Hemoglobin, Visit 21 (Month 76), n=40	-1.5 Grams per liter Standard Deviation 11.67
Change From Baseline in Hemoglobin Hemoglobin, Visit 22 (Month 80), n=35	-0.8 Grams per liter Standard Deviation 9.66
Change From Baseline in Hemoglobin Hemoglobin, Visit 23 (Month 84), n=32	-3.6 Grams per liter Standard Deviation 11.61
Change From Baseline in Hemoglobin Hemoglobin, Visit 24 (Month 88), n=27	-3.0 Grams per liter Standard Deviation 9.46
Change From Baseline in Hemoglobin Hemoglobin, Visit 25 (Month 92), n=25	-2.3 Grams per liter Standard Deviation 8.09
Change From Baseline in Hemoglobin Hemoglobin, Visit 26 (Month 96), n=24	-4.0 Grams per liter Standard Deviation 8.26
Change From Baseline in Hemoglobin Hemoglobin, Visit 27 (Month 100), n=20	-2.8 Grams per liter Standard Deviation 5.82
Change From Baseline in Hemoglobin Hemoglobin, Visit 28 (Month 104), n=16	-2.9 Grams per liter Standard Deviation 9.54
Change From Baseline in Hemoglobin Hemoglobin, Visit 29 (Month 108), n=13	-8.1 Grams per liter Standard Deviation 8.56
Change From Baseline in Hemoglobin Hemoglobin, Visit 30 (Month 112), n=4	-12.5 Grams per liter Standard Deviation 6.14
Change From Baseline in Hemoglobin Hemoglobin, Visit 31 (Month 116), n=3	3.0 Grams per liter Standard Deviation 22.52
Change From Baseline in Hemoglobin Hemoglobin, Visit 32 (Month 120), n=1	25.0 Grams per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Hemoglobin Hemoglobin, Follow up, n=256	-0.1 Grams per liter Standard Deviation 8.89
Change From Baseline in Hemoglobin Hemoglobin, Visit 2 (Month 3), n=316	-0.8 Grams per liter Standard Deviation 7.89
Change From Baseline in Hemoglobin Hemoglobin, Visit 3 (Month 6), n=279	-1.3 Grams per liter Standard Deviation 8.21
Change From Baseline in Hemoglobin Hemoglobin, Visit 3a (Month 8), n=99	-3.0 Grams per liter Standard Deviation 8.70
Change From Baseline in Hemoglobin Hemoglobin, Visit 4 (Month 9), n=244	-0.7 Grams per liter Standard Deviation 8.87
Change From Baseline in Hemoglobin Hemoglobin, Visit 4a (Month 10), n=113	-2.0 Grams per liter Standard Deviation 8.41

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

The hematology parameters included RBC. The clinical laboratory evaluation were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 1 (Month 1), n=349	-0.07 10^12 cells per liter Standard Deviation 0.226
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 2a (Month 4), n=82	-0.06 10^12 cells per liter Standard Deviation 0.233
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 3 (Month 6), n=279	-0.04 10^12 cells per liter Standard Deviation 0.243
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 4a (Month 10), n=113	-0.02 10^12 cells per liter Standard Deviation 0.235
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 5 (Month 12), n=226	-0.04 10^12 cells per liter Standard Deviation 0.255
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 6 (Month 16), n=199	-0.01 10^12 cells per liter Standard Deviation 0.264
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 7 (Month 20), n=174	-0.02 10^12 cells per liter Standard Deviation 0.243
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 8 (Month 24), n=164	-0.03 10^12 cells per liter Standard Deviation 0.281
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 9 (Month 28), n=142	0.00 10^12 cells per liter Standard Deviation 0.271
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 10 (Month 32), n=126	-0.05 10^12 cells per liter Standard Deviation 0.286
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 11 (Month 36), n=115	-0.09 10^12 cells per liter Standard Deviation 0.283
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 12 (Month 40), n=109	-0.02 10^12 cells per liter Standard Deviation 0.275
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 13 (Month 44), n=98	-0.06 10^12 cells per liter Standard Deviation 0.287
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 14 (Month 48), n=101	-0.10 10^12 cells per liter Standard Deviation 0.280
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 15 (Month 52), n=88	-0.08 10^12 cells per liter Standard Deviation 0.285
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 16 (Month 56), n=76	-0.08 10^12 cells per liter Standard Deviation 0.252
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 17 (Month 60), n=89	-0.07 10^12 cells per liter Standard Deviation 0.323
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 18 (Month 64), n=54	-0.01 10^12 cells per liter Standard Deviation 0.263
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 19 (Month 68), n=50	0.01 10^12 cells per liter Standard Deviation 0.255
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 20 (Month 72), n=55	-0.03 10^12 cells per liter Standard Deviation 0.239
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 21 (Month 76), n=40	0.02 10^12 cells per liter Standard Deviation 0.346
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 22 (Month 80), n=35	0.09 10^12 cells per liter Standard Deviation 0.338
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 23 (Month 84), n=32	0.00 10^12 cells per liter Standard Deviation 0.290
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 24 (Month 88), n=27	0.00 10^12 cells per liter Standard Deviation 0.314
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 25 (Month 92), n=25	0.05 10^12 cells per liter Standard Deviation 0.337
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 26 (Month 96), n=24	0.06 10^12 cells per liter Standard Deviation 0.317
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 27 (Month 100), n=20	0.13 10^12 cells per liter Standard Deviation 0.251
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 28 (Month 104), n=16	0.14 10^12 cells per liter Standard Deviation 0.365
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 29 (Month 108), n=13	-0.04 10^12 cells per liter Standard Deviation 0.328
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 30 (Month 112), n=4	0.08 10^12 cells per liter Standard Deviation 0.386
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 31 (Month 116), n=3	0.10 10^12 cells per liter Standard Deviation 0.346
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 32 (Month 120), n=1	0.00 10^12 cells per liter Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Follow up, n=256	-0.01 10^12 cells per liter Standard Deviation 0.263
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 1a (Month 2), n=65	0.00 10^12 cells per liter Standard Deviation 0.236
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 2 (Month 3), n=316	-0.02 10^12 cells per liter Standard Deviation 0.237
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 3a (Month 8), n=99	-0.05 10^12 cells per liter Standard Deviation 0.269
Change From Baseline in Hematology Parameter Red Blood Cells (RBC) RBC, Visit 4 (Month 9), n=244	-0.03 10^12 cells per liter Standard Deviation 0.256

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

Urine specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. Urinalysis assessments were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 1a (Month 2), n=1	0.0000 Ratio Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 2 (Month 3), n=312	-0.0011 Ratio Standard Deviation 0.00918
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 3 (Month 6), n=270	0.0003 Ratio Standard Deviation 0.00896
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 4 (Month 9), n=243	0.0002 Ratio Standard Deviation 0.00984
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 5 (Month 12), n=221	-0.0010 Ratio Standard Deviation 0.01014
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 7 (Month 20), n=170	0.0015 Ratio Standard Deviation 0.00901
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 9 (Month 28), n=137	0.0007 Ratio Standard Deviation 0.00922
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 11 (Month 36), n=111	-0.0016 Ratio Standard Deviation 0.01058
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 12 (Month 40), n=106	0.0004 Ratio Standard Deviation 0.01007
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 14 (Month 48), n=99	0.0000 Ratio Standard Deviation 0.01019
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 15 (Month 52), n=83	-0.0100 Ratio Standard Deviation 0.10022
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 16 (Month 56), n=71	0.0003 Ratio Standard Deviation 0.01089
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 17 (Month 60), n=84	-0.0008 Ratio Standard Deviation 0.01022
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 18 (Month 64), n=53	0.0006 Ratio Standard Deviation 0.00894
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 19 (Month 68), n=50	0.0014 Ratio Standard Deviation 0.01052
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 20 (Month 72), n=55	-0.0021 Ratio Standard Deviation 0.00882
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 21 (Month 76), n=39	0.0030 Ratio Standard Deviation 0.00837
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 22 (Month 80), n=35	0.0015 Ratio Standard Deviation 0.00939
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 23 (Month 84), n=31	0.0024 Ratio Standard Deviation 0.00917
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 24 (Month 88), n=28	0.0043 Ratio Standard Deviation 0.00994
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 25 (Month 92), n=25	0.0046 Ratio Standard Deviation 0.00861
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 28 (Month 104), n=16	0.0026 Ratio Standard Deviation 0.00713
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 30 (Month 112), n=4	0.0020 Ratio Standard Deviation 0.00673
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 31 (Month 116), n=3	0.0030 Ratio Standard Deviation 0.01082
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 32 (Month 120), n=1	-0.0010 Ratio Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Urine Specific Gravity Specific gravity, Follow up, n=247	0.0008 Ratio Standard Deviation 0.00889
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 1 (Month 1), n=348	-0.0011 Ratio Standard Deviation 0.00936
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 6 (Month 16), n=196	0.0006 Ratio Standard Deviation 0.01016
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 8 (Month 24), n=157	0.0002 Ratio Standard Deviation 0.01015
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 10 (Month 32), n=124	0.0001 Ratio Standard Deviation 0.00986
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 13 (Month 44), n=97	0.0004 Ratio Standard Deviation 0.00944
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 26 (Month 96), n=26	0.0035 Ratio Standard Deviation 0.00857
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 27 (Month 100), n=20	0.0029 Ratio Standard Deviation 0.00718
Change From Baseline in Urine Specific Gravity Specific gravity, Visit 29 (Month 108), n=13	0.0020 Ratio Standard Deviation 0.00709

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. Urinalysis assessments were performed at all study visits during the Open-Label Treatment Phase. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 1 (Month 1), n=349	-0.13 Points on a scale Standard Deviation 0.685
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 2 (Month 3), n=313	-0.09 Points on a scale Standard Deviation 0.699
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 4 (Month 9), n=245	0.02 Points on a scale Standard Deviation 0.633
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 5 (Month 12), n=222	-0.02 Points on a scale Standard Deviation 0.616
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 6 (Month 16), n=196	0.07 Points on a scale Standard Deviation 0.651
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 7 (Month 20), n=170	0.04 Points on a scale Standard Deviation 0.686
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 8 (Month 24), n=158	0.09 Points on a scale Standard Deviation 0.672
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 9 (Month 28), n=138	0.17 Points on a scale Standard Deviation 0.787
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 10 (Month 32), n=124	0.17 Points on a scale Standard Deviation 0.715
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 11 (Month 36), n=111	0.26 Points on a scale Standard Deviation 0.663
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 12 (Month 40), n=107	0.30 Points on a scale Standard Deviation 0.700
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 14 (Month 48), n=99	0.38 Points on a scale Standard Deviation 0.722
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 15 (Month 52), n=83	0.27 Points on a scale Standard Deviation 0.621
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 17 (Month 60), n=84	0.32 Points on a scale Standard Deviation 0.662
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 18 (Month 64), n=53	0.33 Points on a scale Standard Deviation 0.627
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 19 (Month 68), n=50	0.42 Points on a scale Standard Deviation 0.785
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 20 (Month 72), n=55	0.27 Points on a scale Standard Deviation 0.686
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 21 (Month 76), n=39	0.36 Points on a scale Standard Deviation 0.688
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 22 (Month 80), n=35	0.23 Points on a scale Standard Deviation 0.657
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 23 (Month 84), n=31	0.35 Points on a scale Standard Deviation 0.661
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 24 (Month 88), n=28	0.29 Points on a scale Standard Deviation 0.517
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 25 (Month 92), n=25	0.36 Points on a scale Standard Deviation 0.621
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 26 (Month 96), n=26	0.21 Points on a scale Standard Deviation 0.551
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 27 (Month 100), n=20	0.45 Points on a scale Standard Deviation 0.724
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 28 (Month 104), n=16	0.13 Points on a scale Standard Deviation 0.342
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 29 (Month 108), n=13	0.77 Points on a scale Standard Deviation 0.753
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 30 (Month 112), n=4	0.50 Points on a scale Standard Deviation 0.577
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 31 (Month 116), n=3	-0.17 Points on a scale Standard Deviation 0.764
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 32 (Month 120), n=1	0.00 Points on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Follow up, n=248	0.22 Points on a scale Standard Deviation 0.746
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 1a (Month 2), n=1	0.50 Points on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 3 (Month 6), n=270	-0.07 Points on a scale Standard Deviation 0.634
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 13 (Month 44), n=97	0.36 Points on a scale Standard Deviation 0.736
Change From Baseline in Urine Potential of Hydrogen (pH) pH, Visit 16 (Month 56), n=71	0.34 Points on a scale Standard Deviation 0.840

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

The post-void residual urine volume in the bladder was evaluated by transabdominal ultrasound. The urine bladder was sonicated from two directions perpendicular to one another, and the volume calculated automatically. A PVR bladder ultrasound to assess urinary retention was performed during the first year at Months 1, 3 and 12 and at the end of each 12 month study cycle that the participant was enrolled (i.e., second year, third year, fourth year, etc.) in the Open-Label Treatment Phase of the study. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume PVR urine volume, Visit 5 (Month 12), n=223	4.1 Milliliters Standard Deviation 52.38
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume PVR urine volume, Visit 14 (Month 48), n=96	-2.3 Milliliters Standard Deviation 39.69
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume PVR urine volume, Visit 1 (Month 1), n=337	4.6 Milliliters Standard Deviation 52.10
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume PVR urine volume, Visit 2 (Month 3), n=307	4.1 Milliliters Standard Deviation 40.88
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume PVR urine volume, Visit 8 (Month 24), n=111	5.5 Milliliters Standard Deviation 67.28
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume PVR urine volume, Visit 11 (Month 36), n=106	5.0 Milliliters Standard Deviation 46.29
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume PVR urine volume, Visit 17 (Month 60), n=77	22.2 Milliliters Standard Deviation 87.43
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume PVR urine volume, Visit 20 (Month 72), n=53	7.1 Milliliters Standard Deviation 49.87
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume PVR urine volume, Visit 23 (Month 84), n=29	15.7 Milliliters Standard Deviation 74.06
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume PVR urine volume, Visit 26 (Month 96), n=24	2.0 Milliliters Standard Deviation 38.54
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume PVR urine volume, Visit 29 (Month 108), n=10	21.9 Milliliters Standard Deviation 63.58
Change From Baseline in Post-Void Residual (PVR) Bladder Ultrasound Volume PVR urine volume, Follow up, n=186	-4.0 Milliliters Standard Deviation 47.11

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

AUA Symptom Index was completed during the first year at Months 1, 3, 12 and at the end of each 12 month study cycle that the participant was enrolled in the Open-Label Treatment Phase (second, third, fourth year) to assess the participant UVF. The questions were scored on a scale of 0 to 5, with 0 (not at all) to 5 (almost always). A Symptom Index is determined by adding the scores. The lowest possible score is 0 and the highest possible score is 35, which would represent the highest level of pain and discomfort. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed represented by (n=x).

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) AUA Overall Score, Visit 2 (Month 3), n=325	-0.5 Scores on a scale Standard Deviation 3.80
Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) AUA Overall Score, Visit 5 (Month 12), n=228	-0.5 Scores on a scale Standard Deviation 3.58
Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) AUA Overall Score, Visit 8 (Month 24), n=114	-0.5 Scores on a scale Standard Deviation 3.84
Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) AUA Overall Score, Visit 11 (Month 36), n=115	-0.3 Scores on a scale Standard Deviation 5.22
Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) AUA Overall Score, Visit 14 (Month 48), n=102	-0.6 Scores on a scale Standard Deviation 4.89
Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) AUA Overall Score, Visit 17 (Month 60), n=87	-0.4 Scores on a scale Standard Deviation 5.02
Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) AUA Overall Score, Visit 23 (Month 84), n=32	0.8 Scores on a scale Standard Deviation 6.61
Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) AUA Overall Score, Visit 1 (Month 1), n=348	-0.4 Scores on a scale Standard Deviation 3.82
Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) AUA Overall Score, Visit 20 (Month 72), n=56	-0.1 Scores on a scale Standard Deviation 5.52
Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) AUA Overall Score, Visit 26 (Month 96), n=26	0.5 Scores on a scale Standard Deviation 5.58
Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) AUA Overall Score, Visit 29 (Month 108), n=13	0.0 Scores on a scale Standard Deviation 1.68
Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) AUA Overall Score, Visit 32 (Month 120), n=1	0.0 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.
Change From Baseline in the Urinary Voiding Function [UVF] (Assessed Using the American Urological Association [AUA] Symptom Index) AUA Overall Score, Follow up, n=217	0.0 Scores on a scale Standard Deviation 4.43

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

The QOLIE-31-P questionnaire contained 30 items. The subscale scores (seizure worry, overall QOL, emotional well-being, energy-fatigue, cognitive, medication effects, social functioning), the final QOLIE-31-P score and the weighted total score (overall assessment) were calculated according to the scoring algorithm defined by the author. Scores range from 0 to 100 with higher scores indicating better function. Baseline was defined as the last assessment of that endpoint in VRX-RET-E22-302 taken prior to the first active treatment with retigabine. Change from Baseline was calculated by subtracting the Baseline value from the post Baseline values. NA indicates standard deviation could not be calculated as only 1 participant was analyzed. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire Final QOLIE-31-P Score, Visit 3 (Month 6), n=262	0.87 Scores on a scale Standard Deviation 14.618
Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire Final QOLIE-31-P Score, Visit 4 (Month 9), n=229	0.27 Scores on a scale Standard Deviation 14.365
Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire Final QOLIE-31-P Score, Follow up, n=224	-0.83 Scores on a scale Standard Deviation 14.256
Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire Final QOLIE-31-P Score, Visit 2 (Month 3), n=296	1.33 Scores on a scale Standard Deviation 14.409
Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire Final QOLIE-31-P Score, Visit 5 (Month 12), n=214	1.24 Scores on a scale Standard Deviation 14.498
Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire Final QOLIE-31-P Score, Visit 8 (Month 24), n=142	3.76 Scores on a scale Standard Deviation 12.406
Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire Final QOLIE-31-P Score, Visit 11 (Month 36), n=97	2.77 Scores on a scale Standard Deviation 13.784
Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire Final QOLIE-31-P Score, Visit 14 (Month 48), n=83	0.78 Scores on a scale Standard Deviation 13.976
Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire Final QOLIE-31-P Score Visit 17 (Month 60), n=68	2.37 Scores on a scale Standard Deviation 15.197
Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire Final QOLIE-31-P Score Visit 20 (Month 72), n=47	3.07 Scores on a scale Standard Deviation 16.172
Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire Final QOLIE-31-P Score Visit 23 (Month 84), n=26	4.31 Scores on a scale Standard Deviation 13.849
Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire Final QOLIE-31-P Score Visit 26 (Month 96), n=24	4.07 Scores on a scale Standard Deviation 11.745
Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire Final QOLIE-31-P Score Visit 29 (Month 108), n=12	6.35 Scores on a scale Standard Deviation 14.783
Change From Baseline in Quality of Life in Epilepsy-31-Problems (QOLIE-31-P) Questionnaire Final QOLIE-31-P Score Visit 32 (Month 120), n=1	14.36 Scores on a scale Standard Deviation NA Standard deviation could not be calculated as only 1 participant was analyzed.

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

A complete physical examination was performed at the end of each 12 month study cycle (i.e., first year, second year, third year, etc.) during the Open-Label Treatment Phase. The investigator assessed the skin at every clinic visit. If abnormal skin discoloration was confirmed, the participant continued to be followed by the dermatologist. If the abnormal skin discoloration was not confirmed, the investigator resumed assessing the participants skin at all scheduled clinic visits. Only data for abnormal values on physical examination have been presented. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Percentage of Participants With Abnormal Results of Physical Examination Visit 5 (Month 12), n=234	18 Percentage of participants
Percentage of Participants With Abnormal Results of Physical Examination Visit 8 (Month 24), n=166	17 Percentage of participants
Percentage of Participants With Abnormal Results of Physical Examination Visit 11 (Month 36), n=121	21 Percentage of participants
Percentage of Participants With Abnormal Results of Physical Examination Visit 14 (Month 48), n=104	19 Percentage of participants
Percentage of Participants With Abnormal Results of Physical Examination Visit 17 (Month 60), n=88	19 Percentage of participants
Percentage of Participants With Abnormal Results of Physical Examination Visit 20 (Month 72), n=58	24 Percentage of participants
Percentage of Participants With Abnormal Results of Physical Examination Visit 23 (Month 84), n=32	34 Percentage of participants
Percentage of Participants With Abnormal Results of Physical Examination Visit 26 (Month 96), n=26	35 Percentage of participants
Percentage of Participants With Abnormal Results of Physical Examination Visit 29 (Month 108), n=13	38 Percentage of participants
Percentage of Participants With Abnormal Results of Physical Examination Follow up visit, n=260	27 Percentage of participants

PRIMARY outcome

Timeframe: Baseline and up to 122 months

Population: Safety Population

A complete neurological examination was performed at the end of each 12 month study cycle (i.e., first year, second year, third year, etc.) during the Open-Label Treatment Phase. Abnormal results were categorized as Abnormal-Not Clinically Significant (A-NCS) and Abnormal and Clinically Significant (A-CS). Only data for abnormal values on neurological examination have been presented. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Retigabine n=376 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Percentage of Participants With Abnormal Results of Neurological Examination Visit 1 (Month 1), A-NCS, n=356	23 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 1 (Month 1), A-CS, n=356	10 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 2 (Month 3), A-NCS, n=328	23 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 2 (Month 3), A-CS, n=328	9 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 3 (Month 6), A-NCS, n=287	22 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 3 (Month 6), A-CS, n=287	10 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 4 (Month 9), A-NCS, n=252	23 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 9 (Month 28), A-CS, n=146	8 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 10 (Month 32), A-NCS, n=127	32 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 11 (Month 36), A-NCS, n=121	35 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 11 (Month 36), A-CS, n=121	8 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 12 (Month 40), A-NCS, n=112	28 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 12 (Month 40), A-CS, n=112	10 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 13 (Month 44), A-NCS, n=105	31 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 13 (Month 44), A-CS, n=105	9 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 14 (Month 48), A-NCS, n=104	28 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 14 (Month 48), A-CS, n=104	11 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 15 (Month 52), A-NCS, n=91	31 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 15 (Month 52), A-CS, n=91	9 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 16 (Month 56), A-NCS, n=77	32 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 16 (Month 56), A-CS, n=77	9 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 17 (Month 60), A-NCS, n=89	29 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 20 (Month 72), A-NCS, n=59	41 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 23 (Month 84), A-CS, n=32	3 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 24 (Month 88), A-CS, n=29	7 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 26 (Month 96), A-CS, n=26	15 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 28 (Month 104), A-CS, n=17	24 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 29 (Month 108), A-NCS, n=13	31 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 29 (Month 108), A-CS, n=13	8 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Follow up visit, A-NCS, n=263	22 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Follow up visit, A-CS, n=263	8 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 4 (Month 9), A-CS, n=252	11 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 5 (Month 12), A-NCS, n=234	27 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 5 (Month 12), A-CS, n=234	12 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 6 (Month 16), A-NCS, n=202	24 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 6 (Month 16), A-CS, n=202	9 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 7 (Month 20), A-NCS, n=179	25 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 7 (Month 20), A-CS, n=179	9 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 8 (Month 24), A-NCS, n=166	34 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 8 (Month 24), A-CS, n=166	10 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 9 (Month 28), A-NCS, n=146	32 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 10 (Month 32), A-CS, n=127	8 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 17 (Month 60), A-CS, n=89	9 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 18 (Month 64), A-NCS, n=58	29 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 18 (Month 64), A-CS, n=58	10 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 19 (Month 68), A-NCS, n=53	36 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 19 (Month 68), A-CS, n=53	9 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 20 (Month 72), A-CS, n=59	7 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 21 (Month 76), A-NCS, n=43	40 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 21 (Month 76), A-CS, n=43	7 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 22 (Month 80), A-NCS, n=37	41 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 22 (Month 80), A-CS, n=37	5 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 23 (Month 84), A-NCS, n=32	47 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 24 (Month 88), A-NCS, n=29	45 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 25 (Month 92), A-NCS, n=25	40 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 25 (Month 92), A-CS, n=25	8 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 26 (Month 96), A-NCS, n=26	42 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 27 (Month 100), A-NCS, n=19	21 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 27 (Month 100), A-CS, n=19	16 Percentage of participants
Percentage of Participants With Abnormal Results of Neurological Examination Visit 28 (Month 104), A-NCS, n=17	24 Percentage of participants

SECONDARY outcome

Timeframe: Up to 121 months

Population: Safety Population

RPA was determined by either an ophthalmologist or retina specialist. RPA is the composite endpoint assessed by its components: pigmentary abnormalities (PA) in the macula, PA in the peripheral retina (PR), PA in both macula and PR and PA at location unspecified. Only those participants with \>=1 ophthalmology exam on or before last dose of retigabine are presented..

Outcome measures

Outcome measures
Measure	Retigabine n=54 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Percentage of Participants With Retinal Pigmentary Abnormalities (RPA) RPA	31 Percentage of participants
Percentage of Participants With Retinal Pigmentary Abnormalities (RPA) PA in the macula	22 Percentage of participants
Percentage of Participants With Retinal Pigmentary Abnormalities (RPA) PA of the PR	22 Percentage of participants
Percentage of Participants With Retinal Pigmentary Abnormalities (RPA) PA in both the macula and PR	13 Percentage of participants
Percentage of Participants With Retinal Pigmentary Abnormalities (RPA) PA: location unspecified	2 Percentage of participants

SECONDARY outcome

Timeframe: Up to 121 months

Population: Safety Population

Non-retinal ocular tissue abnormalities were determined by either an ophthalmologist or retina specialist. Non-ret. Pig. Abn is a composite endpoint assessed by its components: abnormal pigmentation (ABP) of the sclera and/or conjunctiva, ABP of the cornea, ABP of the iris and ABP of the lens. Only those participants with \>=1 ophthalmology exam on or before last dose of retigabine are presented.

Outcome measures

Outcome measures
Measure	Retigabine n=54 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Percentage of Participants With Pigmentation of Non-retinal Ocular Tissue (Non-ret. Pig. Abn) Non-ret. Pig. Abn	28 Percentage of participants
Percentage of Participants With Pigmentation of Non-retinal Ocular Tissue (Non-ret. Pig. Abn) ABP of sclera and/or conjunctiva	13 Percentage of participants
Percentage of Participants With Pigmentation of Non-retinal Ocular Tissue (Non-ret. Pig. Abn) ABP of the cornea	4 Percentage of participants
Percentage of Participants With Pigmentation of Non-retinal Ocular Tissue (Non-ret. Pig. Abn) ABP of the iris	17 Percentage of participants
Percentage of Participants With Pigmentation of Non-retinal Ocular Tissue (Non-ret. Pig. Abn) ABP of the lens	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 121 months

Population: Safety Population

Abnormal discoloration of the skin was determined by a dermatologist. The parameters assessed were abnormal discoloration of the skin, abnormal discoloration of the lips, abnormal discoloration of the nails, abnormal discoloration of the mucosa, abnormal discoloration of sun-exposed tissue, abnormal discoloration of non sun-exposed tissue. Only those participants with at least one skin exam by the investigator or dermatologist on or before the last dose of retigabine or dermatologist-confirmed discoloration with start date on or before the date of last dose of retigabine are presented.

Outcome measures

Outcome measures
Measure	Retigabine n=46 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa Any abnormal dermatologic discoloration	50 Percentage of participants
Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa Abnormal discoloration of skin	37 Percentage of participants
Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa Abnormal discoloration of lips	26 Percentage of participants
Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa Abnormal discoloration of nails	41 Percentage of participants
Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa Abnormal discoloration of mucosa	30 Percentage of participants
Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa Abnormal discoloration of sun-exposed tissue	48 Percentage of participants
Percentage of Participants With Abnormal Pigmentation of Skin, Including the Skin Around the Eyes and the Eyelids, Lips, Nails, or Mucosa Abnormal discoloration of non sun-exposed tissue	37 Percentage of participants

SECONDARY outcome

Timeframe: Up to 121 months

Population: Safety Population

VA refers to the clarity of vision. The parameters assessed were CSD in VA from initial examination which can be explained and CSD in VA from initial examination which cannot be explained. Only those participants with both initial and at least 1 follow-up exam while on retigabine are presented.

Outcome measures

Outcome measures
Measure	Retigabine n=38 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Percentage of Participants With a Clinically Significant Decrease (CSD) in Visual Acuity (VA) From Initial Examination CSD in VA from initial examination, n=38	13 Percentage of participants
Percentage of Participants With a Clinically Significant Decrease (CSD) in Visual Acuity (VA) From Initial Examination CSD which can be explained (Form 2), n=34	12 Percentage of participants
Percentage of Participants With a Clinically Significant Decrease (CSD) in Visual Acuity (VA) From Initial Examination CSD which can not be explained (Form 2), n=34	0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 121 months

Population: Safety Population

The parameter assessed was decrease in confrontation visual field from initial examination. Only those participants with data available at the indicated time point were analyzed. Only those participants with both initial and at least 1 follow-up exam while on retigabine are presented.

Outcome measures

Outcome measures
Measure	Retigabine n=38 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Percentage of Participants With Decrease in Confrontation Visual Field From Initial Examination	13 Percentage of participants

SECONDARY outcome

Timeframe: 3 years and 10 months

Population: All SFUCP Subjects Population included participants with one or more finding(s) of abnormal pigmentation of the retina or unexplained vision loss, pigmentation of non-retinal ocular tissue or discoloration of skin, lips, nails or mucosa at the treatment phase withdrawal/follow-up visit and who enter the SFUCP phase.

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. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Retigabine n=26 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine Non-retinal ocular pigmentary abnormality	8 Participants
Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine Retinal pigmentary abnormality	0 Participants
Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine Pigmentary abnormality of macula	1 Participants
Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of Retigabine Pigmentary abnormality of peripheral retina	2 Participants

SECONDARY outcome

Timeframe: 3 years and 10 months

Population: All SFUCP Subjects Population

An assessment of the participant's nails, lips, skin and mucosa was completed by the investigator at the 6 monthly SFUCP study visits. 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 n=26 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Number of Participants With Resolution of Dermatologist Confirmed Abnormal Discoloration After Discontinuation of Retigabine	7 Participants

SECONDARY outcome

Timeframe: 3 years and 10 months

Population: All SFUCP Subjects Population

Retinal pigmentary abnormality was determined by either an ophthalmologist or retina specialist. Retinal pigmentary abnormality included pigmentary abnormality of macula, pigmentary abnormality of the peripheral retina and non-retinal ocular pigmentary abnormality. 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 location (conjunctiva, sclera, cornea, iris or lens), all should be resolved for non-retinal pigmentary abnormality to be considered resolved. Only participants with resolution of the specified pigmentation are included in this analysis.

Outcome measures

Outcome measures
Measure	Retigabine n=26 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation Pigmentary Abnormality of Macula, n=1	233.0 Days Interval 233.0 to 233.0
Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation Pigmentary Abnormality of Peripheral Retina, n=2	307.0 Days Interval 245.0 to 369.0
Time From Discontinuation of Retigabine to Resolution of Abnormal Eye Pigmentation Non-Retinal Ocular Pigmentary Abnormality, n=8	312.0 Days Interval 9.0 to 538.0

SECONDARY outcome

Timeframe: 3 years and 10 months

Population: All SFUCP Subjects Population

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 n=26 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration Lips, n=5	379.0 Days Interval 197.0 to 672.0
Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration Nails,n=7	379.0 Days Interval 197.0 to 462.0
Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration All, n=7	380.0 Days Interval 197.0 to 672.0
Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration Skin, n=6	382.5 Days Interval 162.0 to 425.0
Time From Discontinuation of Retigabine to Resolution of All Dermatologist-Confirmed Abnormal Discoloration Mucosa, n=8	201.0 Days Interval 175.0 to 425.0

SECONDARY outcome

Timeframe: Baseline and up to 121 months

Population: Safety Population

28-day partial seizure rate observed during the OLE period was compared to the 28-day partial seizure rate observed during the Baseline phase of the double-blind parent study VRX-R ET-E22-302. Percent change from Baseline in 28-day total partial seizure rate was calculated as (\[28-day partial seizure frequency for the period of interest - Baseline 28-day partial seizure frequency\] / Baseline 28-day partial seizure frequency) × 100 percent. A negative percent change indicated a reduction (improvement) from Baseline, so the best possible outcome was -100 percent. Only those participants with data available at the indicated time point were analyzed.

Outcome measures

Outcome measures
Measure	Retigabine n=371 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Percentage Change in the 28-day Partial Seizure Rate From the Baseline Phase (Obtained During the 8-week Baseline Period of Study VRX-RET-E22-302) to Open-label Treatment.	-36.1 Percent change Standard Deviation 95.77

SECONDARY outcome

Timeframe: Baseline and up to 121 months

Population: Safety Population

A Responder was defined as a participant with \>=50 percent decrease from Baseline in the 28-day partial seizure frequency, i.e., a percent change from Baseline less than or equal to -50 percent. The percentage of responders from Baseline phase of the parent study (VRX-RET-E22-302) to open label treatment have been presented.

Outcome measures

Outcome measures
Measure	Retigabine n=371 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Percentage of Participants With 50% Reduction in Seizure Frequency From Baseline Phase of the Parent Study (VRX-RET-E22-302) to Open Label Treatment	52 Percentage of participants

SECONDARY outcome

Timeframe: Up to 6 continuous months within the 121 months period

Population: Safety Population

Seizure free for any continuous 6 months is defined as no seizures occuring during any consecutive 180 days between the first date (Baseline) and the last date (before tapering of dose). The number of participants who were seizure free for 6 continuous months within the 121 month OLE period have been presented.

Outcome measures

Outcome measures
Measure	Retigabine n=279 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Number of Participants Who Were Seizure Free for Any 6 Continuous Months	36 Participants

SECONDARY outcome

Timeframe: Up to 12 continuous months within the 121 months period

Population: Safety Population

Seizure free for any continuous 12 months is defined as no seizures occurring during any consecutive 360 days. Number of participants who were seizure free for 12 continuous months within the 121 month OLE period have been presented.

Outcome measures

Outcome measures
Measure	Retigabine n=222 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Number of Participants Who Were Seizure Free for Any 12 Continuous Months	22 Participants

SECONDARY outcome

Timeframe: Up to 121 months

Population: Safety Population

A seizure free day is defined as the number of applicable days without any seizures (partial, generalized or unclassified). Only the days in which a subject had non-missing seizure data were considered as applicable days. Percentage of seizure free days is calculated as Number of seizure free days / number of applicable days × 100 percent. Only those participants with data available at the indicated time point were analyzed.

Outcome measures

Outcome measures
Measure	Retigabine n=371 Participants Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Percentage of Seizure Free Days	76.8 Percentage of days Standard Deviation 26.11

Adverse Events

Retigabine

Serious events: 78 serious events

Other events: 239 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Retigabine n=376 participants at risk Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Nervous system disorders Seizure	4.3% 16/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Epilepsy	1.6% 6/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Generalised tonic-clonic seizure	1.3% 5/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Status epilepticus	1.3% 5/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Dizziness	0.80% 3/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Focal dyscognitive seizures	0.80% 3/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Coma	0.53% 2/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Arachnoid cyst	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Ataxia	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Cerebrovascular accident	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Depressed level of consciousness	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Dysarthria	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Facial paralysis	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Incoherent	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Partial seizures	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Partial seizures with secondary generalisation	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Seizure cluster	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Psychiatric disorders Psychotic disorder	1.1% 4/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Psychiatric disorders Confusional state	0.80% 3/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Psychiatric disorders Psychogenic seizure	0.53% 2/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Psychiatric disorders Aggression	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Psychiatric disorders Agitation	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Psychiatric disorders Anxiety	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Psychiatric disorders Disorientation	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Psychiatric disorders Epileptic psychosis	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Psychiatric disorders Hallucination	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Psychiatric disorders Hallucination, auditory	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Psychiatric disorders Hallucinations, mixed	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Psychiatric disorders Obsessive-compulsive personality disorder	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Psychiatric disorders Postictal psychosis	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Psychiatric disorders Suicidal ideation	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Psychiatric disorders Suicide attempt	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Injury, poisoning and procedural complications Accidental overdose	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Injury, poisoning and procedural complications Burns second degree	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Injury, poisoning and procedural complications Burns third degree	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Injury, poisoning and procedural complications Fall	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Injury, poisoning and procedural complications Femoral neck fracture	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Injury, poisoning and procedural complications Foot fracture	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Injury, poisoning and procedural complications Head injury	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Injury, poisoning and procedural complications Hip fracture	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Injury, poisoning and procedural complications Humerus fracture	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Injury, poisoning and procedural complications Intentional overdose	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Injury, poisoning and procedural complications Jaw fracture	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Injury, poisoning and procedural complications Near drowning	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Injury, poisoning and procedural complications Radius fracture	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Injury, poisoning and procedural complications Rib fracture	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Injury, poisoning and procedural complications Road traffic accident	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Injury, poisoning and procedural complications Skull fractured base	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Infections and infestations Appendicitis	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Infections and infestations Bronchitis	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Infections and infestations Cellulitis	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Infections and infestations Gastroenteritis	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Infections and infestations Pneumonia	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Infections and infestations Pneumonia mycoplasmal	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Infections and infestations Pneumonia streptococcal	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Infections and infestations Septic shock	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Infections and infestations Typhoid fever	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Eye disorders Retinal pigmentation	0.80% 3/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Eye disorders Diplopia	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Eye disorders Vision blurred	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
General disorders Sudden unexplained death in epilepsy	0.80% 3/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
General disorders Chest pain	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
General disorders Non-cardiac chest pain	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Vascular disorders Deep vein thrombosis	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Vascular disorders Hypertensive crisis	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Vascular disorders Peripheral arterial occlusive disease	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Vascular disorders Peripheral ischaemia	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Cardiac disorders Angina pectoris	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Cardiac disorders Atrial fibrillation	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Cardiac disorders Cardiac arrest	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Gastrointestinal disorders Acute abdomen	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Gastrointestinal disorders Intestinal obstruction	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Gastrointestinal disorders Nausea	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Gastrointestinal disorders Vomiting	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Hepatobiliary disorders Cholecystitis	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Hepatobiliary disorders Cholelithiasis	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Hepatobiliary disorders Drug-induced liver injury	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Metabolism and nutrition disorders Hyponatraemia	0.53% 2/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Musculoskeletal and connective tissue disorders Pain in extremity	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Renal and urinary disorders Hydronephrosis	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Renal and urinary disorders Nephropathy toxic	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.53% 2/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Ear and labyrinth disorders Vertigo	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Endocrine disorders Adrenal insufficiency	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Skin and subcutaneous tissue disorders Pigmentation disorder	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Social circumstances Treatment noncompliance	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Surgical and medical procedures Tracheostomy	0.27% 1/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.

Other adverse events

Other adverse events
Measure	Retigabine n=376 participants at risk Eligible participants entered a 4-week transition phase of the double-blind parent study (study VRX-RET-E22-302), in which their dose of retigabine was titrated to or maintained at 300 mg three times daily (900 mg per day). Upon completion of the Transition phase of the parent study, participants enrolled into the extension study (RTG115097). Once enrolled in the OLE, doses were adjusted within the range of 600 mg to 1200 mg per day as an adjunct therapy to their ongoing AEDs with or without VNS up to 121 months.
Nervous system disorders Dizziness	22.1% 83/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Somnolence	20.7% 78/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Headache	16.2% 61/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Tremor	9.0% 34/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Memory impairment	6.9% 26/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Seizure	5.9% 22/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Aphasia	5.3% 20/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Nervous system disorders Amnesia	5.1% 19/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Infections and infestations Viral upper respirator tract infection	8.0% 30/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Infections and infestations Influenza	6.4% 24/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Infections and infestations Urinary tract infection	5.6% 21/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
General disorders Fatigue	11.4% 43/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Musculoskeletal and connective tissue disorders Back pain	5.9% 22/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Gastrointestinal disorders Oral mucosal discolouration	5.3% 20/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.
Ear and labyrinth disorders Vertigo	5.1% 19/376 • Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study treatment up to 122 months. Safety population was used to assess AEs and SAEs.

Additional Information

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GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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

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