Trial Outcomes & Findings for A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy (NCT NCT04836559)

Last Updated: 2025-07-03

Results Overview

Time (in days) to baseline monthly seizure count was defined as the number of days until the participants cumulative seizure count during the DB period was equal to their baseline monthly seizure count. The baseline monthly seizure count was defined as the number of observable focal onset seizures occurred during the 8-week baseline period (Day -56 to -1), multiplied by 28/XBL, where XBL was the number of days comprising the participants baseline period. Observable focal onset seizures included focal aware seizures with motor signs, focal impaired awareness seizures and focal to bilateral tonic-clonic seizures. Focal aware seizures without motor signs, myoclonic, or other generalized seizures was not counted towards baseline monthly seizure count. Cluster seizures were counted as a single seizure. Kaplan-Meier method was used for the analysis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

110 participants

Primary outcome timeframe

From DB period Day 1 up to Day 85

Results posted on

2025-07-03

Participant Flow

Participants with diagnosis of focal onset seizures and receiving levetiracetam or brivaracetam and up to 3 other anti-epileptic drugs (AEDs) were enrolled in study. Study consisted of cohort 1 and 2. In each cohort, participants were stratified into two groups: participants treated with a CYP3A4 enzyme inducing anti-epileptic drugs (EIAED \[induced participants\]) and those not treated with a CYP3A4 EIAED (non-induced participants).

PK sets: randomized participants who received at least (\>=)1 dose of JNJ-40411813 and had \>=1 valid blood sample drawn for PK analysis and excluded samples with below lower limit of quantification or with inconsistent date/time or with previous dose date/time incomplete or samples with concentration \<10 nanograms per milliliter. Safety set: randomized participants who received \>=1 dose of JNJ-40411813/placebo. Due to inclusion/exclusion criteria difference, PK set count differed from safety set.

Participant milestones

Participant milestones
Measure	DB: Cohort 1: Placebo During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	OLE: Cohort 1: Placebo Followed by JNJ-40411813 During OLE period, cohort 1 participants who had received placebo during the DB period received JNJ-40411813 100 mg or 50 mg BID along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) from Day 1 of OLE up to 2 years. Induced participants (with EIAEDs) received JNJ-40411813 100 mg, and non-induced participants (without EIAEDs) received JNJ-40411813 50 mg. The dose could be increased at the second visit (Month 1) to 200 mg of JNJ-40411813 BID for induced participants (with EIAEDs) and 100 mg of JNJ-40411813 BID for non-induced participants (without EIAEDs).	OLE: Cohort 1: JNJ-40411813 Followed by JNJ-40411813 During OLE period, cohort 1 participants who had received JNJ-40411813 during the DB period continued to receive JNJ-40411813 100 mg or 50 mg BID along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) from Day 1 of OLE up to 2 years. Induced participants (with EIAEDs) received JNJ-40411813 100 mg, and non-induced participants (without EIAEDs) received JNJ-40411813 50 mg. The dose could be increased at the second visit (Month 1) to 200 mg of JNJ-40411813 BID for induced participants (with EIAEDs) and 100 mg of JNJ-40411813 BID for non-induced participants (without EIAEDs).	OLE: Cohort 2: Placebo Followed by JNJ-40411813 During the OLE period, cohort 2 participants who had received placebo during the DB period received JNJ-40411813 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) from Day 1 of OLE up to 2 years. Participants started with JNJ-40411813 100 mg BID. Induced participants (with EIAEDs) had their dose increased to JNJ-40411813 200 mg BID on Day 8 of the OLE. Non-induced participants (without EIAEDs) continued with JNJ-40411813 100 mg BID.	OLE: Cohort 2: JNJ-40411813 Followed by JNJ-40411813 During OLE period, cohort 2 participants who had received JNJ-40411813 during the DB period continued to receive JNJ-40411813 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) from Day 1 of OLE up to 2 years. Participants started with JNJ-40411813 100 mg BID. Induced participants (with EIAEDs) had their dose increased to JNJ-40411813 200 mg BID on Day 8 of the OLE. Non-induced participants (without EIAEDs) continued with JNJ-40411813 100 mg BID.
Double Blind Period (Day 1 to Day 85) STARTED	20	40	9	41	0	0	0	0
Double Blind Period (Day 1 to Day 85) Full Analysis Set	20	40	9	40	0	0	0	0
Double Blind Period (Day 1 to Day 85) Subjects Treated With EIAED	11	22	6	24	0	0	0	0
Double Blind Period (Day 1 to Day 85) Subjects Not Treated With EIAED	9	18	3	17	0	0	0	0
Double Blind Period (Day 1 to Day 85) COMPLETED	18	35	7	36	0	0	0	0
Double Blind Period (Day 1 to Day 85) NOT COMPLETED	2	5	2	5	0	0	0	0
OLE Period (Day 1 of OLE up to 2 Years) STARTED	0	0	0	0	12	23	7	31
OLE Period (Day 1 of OLE up to 2 Years) Participants Treated With EIAED	0	0	0	0	6	15	4	19
OLE Period (Day 1 of OLE up to 2 Years) Participants Not Treated With EIAED	0	0	0	0	6	8	3	12
OLE Period (Day 1 of OLE up to 2 Years) COMPLETED	0	0	0	0	0	0	0	0
OLE Period (Day 1 of OLE up to 2 Years) NOT COMPLETED	0	0	0	0	12	23	7	31

Reasons for withdrawal

Reasons for withdrawal
Measure	DB: Cohort 1: Placebo During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	OLE: Cohort 1: Placebo Followed by JNJ-40411813 During OLE period, cohort 1 participants who had received placebo during the DB period received JNJ-40411813 100 mg or 50 mg BID along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) from Day 1 of OLE up to 2 years. Induced participants (with EIAEDs) received JNJ-40411813 100 mg, and non-induced participants (without EIAEDs) received JNJ-40411813 50 mg. The dose could be increased at the second visit (Month 1) to 200 mg of JNJ-40411813 BID for induced participants (with EIAEDs) and 100 mg of JNJ-40411813 BID for non-induced participants (without EIAEDs).	OLE: Cohort 1: JNJ-40411813 Followed by JNJ-40411813 During OLE period, cohort 1 participants who had received JNJ-40411813 during the DB period continued to receive JNJ-40411813 100 mg or 50 mg BID along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) from Day 1 of OLE up to 2 years. Induced participants (with EIAEDs) received JNJ-40411813 100 mg, and non-induced participants (without EIAEDs) received JNJ-40411813 50 mg. The dose could be increased at the second visit (Month 1) to 200 mg of JNJ-40411813 BID for induced participants (with EIAEDs) and 100 mg of JNJ-40411813 BID for non-induced participants (without EIAEDs).	OLE: Cohort 2: Placebo Followed by JNJ-40411813 During the OLE period, cohort 2 participants who had received placebo during the DB period received JNJ-40411813 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) from Day 1 of OLE up to 2 years. Participants started with JNJ-40411813 100 mg BID. Induced participants (with EIAEDs) had their dose increased to JNJ-40411813 200 mg BID on Day 8 of the OLE. Non-induced participants (without EIAEDs) continued with JNJ-40411813 100 mg BID.	OLE: Cohort 2: JNJ-40411813 Followed by JNJ-40411813 During OLE period, cohort 2 participants who had received JNJ-40411813 during the DB period continued to receive JNJ-40411813 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) from Day 1 of OLE up to 2 years. Participants started with JNJ-40411813 100 mg BID. Induced participants (with EIAEDs) had their dose increased to JNJ-40411813 200 mg BID on Day 8 of the OLE. Non-induced participants (without EIAEDs) continued with JNJ-40411813 100 mg BID.
Double Blind Period (Day 1 to Day 85) Adverse Event	0	4	1	1	0	0	0	0
Double Blind Period (Day 1 to Day 85) Withdrawal by Subject	0	1	1	3	0	0	0	0
Double Blind Period (Day 1 to Day 85) Protocol Violation	1	0	0	0	0	0	0	0
Double Blind Period (Day 1 to Day 85) Other	1	0	0	0	0	0	0	0
Double Blind Period (Day 1 to Day 85) Randomized by Mistake With Study Treatment	0	0	0	1	0	0	0	0
OLE Period (Day 1 of OLE up to 2 Years) Sponsor's Decision	0	0	0	0	7	14	4	24
OLE Period (Day 1 of OLE up to 2 Years) Lack of Efficacy	0	0	0	0	1	7	3	4
OLE Period (Day 1 of OLE up to 2 Years) Withdrawal by Subject	0	0	0	0	4	2	0	2
OLE Period (Day 1 of OLE up to 2 Years) No Longer Clinically Benefitting	0	0	0	0	0	0	0	1

Baseline Characteristics

A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DB: Cohort 1: Placebo n=20 Participants During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=40 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo n=9 Participants During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=41 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	Total n=110 Participants Total of all reporting groups
Race (NIH/OMB) Asian	5 Participants n=5 Participants	11 Participants n=7 Participants	0 Participants n=5 Participants	10 Participants n=4 Participants	26 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	41.3 Years STANDARD_DEVIATION 12.55 • n=5 Participants	37.5 Years STANDARD_DEVIATION 12.40 • n=7 Participants	39.7 Years STANDARD_DEVIATION 10.84 • n=5 Participants	41.3 Years STANDARD_DEVIATION 11.47 • n=4 Participants	39.8 Years STANDARD_DEVIATION 11.94 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	17 Participants n=7 Participants	5 Participants n=5 Participants	23 Participants n=4 Participants	50 Participants n=21 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	23 Participants n=7 Participants	4 Participants n=5 Participants	18 Participants n=4 Participants	60 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	12 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	37 Participants n=7 Participants	5 Participants n=5 Participants	36 Participants n=4 Participants	97 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	29 Participants n=7 Participants	8 Participants n=5 Participants	30 Participants n=4 Participants	82 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment Belgium	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment Germany	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	7 Participants n=21 Participants
Region of Enrollment Poland	7 Participants n=5 Participants	9 Participants n=7 Participants	3 Participants n=5 Participants	18 Participants n=4 Participants	37 Participants n=21 Participants
Region of Enrollment Russian Federation	2 Participants n=5 Participants	7 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	9 Participants n=21 Participants
Region of Enrollment Korea, South	5 Participants n=5 Participants	11 Participants n=7 Participants	0 Participants n=5 Participants	9 Participants n=4 Participants	25 Participants n=21 Participants
Region of Enrollment Spain	0 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	7 Participants n=4 Participants	14 Participants n=21 Participants
Region of Enrollment Ukraine	2 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	7 Participants n=21 Participants
Region of Enrollment United States	3 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants

PRIMARY outcome

Timeframe: From DB period Day 1 up to Day 85

Population: Full analysis set (FAS) included all randomized participants assigned to receive study intervention and had both baseline and postbaseline seizure data.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo n=20 Participants During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo n=9 Participants During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=40 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=40 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
Cohort 1 and 2: Time to Baseline Monthly Seizure Count up to the End of the 12-week Double-blind (DB) Treatment Period	32 Days Interval 28.0 to 37.0	29 Days Interval 22.0 to 69.0	34 Days Interval 27.0 to 48.0	38 Days Interval 28.0 to 48.0	—	—	—	—

SECONDARY outcome

Timeframe: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant)

Population: Full analysis set: open-label extension (FASOLE) analysis set included all FAS participants who received at least 1 dose of study intervention in the OLE period.

The percent reduction in the OLE monthly seizure rate was defined as 100\*(baseline monthly seizure count minus OLE monthly seizure count) divided by (baseline monthly seizure count). The OLE monthly seizure count was defined as the total number of observable focal onset seizures occurred during the OLE period, multiplied by 28/XOLE, where XOLE was the number of days comprising the OLE. A positive percentage change in the OLE monthly seizure count indicated improvement. Observable seizures included focal aware seizures with motor signs, focal impaired awareness seizures and focal to bilateral tonic-clonic seizures. Focal aware seizures without motor signs, myoclonic, or other generalized seizures was not counted towards baseline monthly seizure count. Cluster seizures were counted as a single seizure.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo n=12 Participants During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo n=7 Participants During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=23 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=31 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
Cohort 1 and 2: Percent Reduction in the Open Label Extension (OLE) Period Monthly Seizure Rate	39.9 Percent change (reduction) Interval 14.3 to 64.1	29.1 Percent change (reduction) Interval 22.6 to 76.6	49.1 Percent change (reduction) Interval -1.5 to 77.1	52.1 Percent change (reduction) Interval -3.7 to 85.0	—	—	—	—

SECONDARY outcome

Timeframe: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant)

Population: FASOLE analysis set included all FAS participants who received at least 1 dose of study intervention in the OLE period.

Number of participants with seizure freedom at the end of OLE period was reported. Seizure freedom was defined as having no seizures over the complete OLE study period.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo n=12 Participants During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo n=7 Participants During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=23 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=31 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
Cohort 1 and 2: Number of Participants With Seizure Freedom at the End of OLE Period	1 Participants Interval 14.3 to 64.1	0 Participants Interval 22.6 to 76.6	0 Participants Interval -1.5 to 77.1	3 Participants Interval -3.7 to 85.0	—	—	—	—

SECONDARY outcome

Timeframe: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant)

Population: FASOLE analysis set included all FAS participants who received at least 1 dose of study intervention in the OLE period.

Number of participants having at least a 50% reduction in the monthly seizure rate (response) during the OLE study period was reported.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo n=12 Participants During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo n=7 Participants During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=23 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=31 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
Cohort 1 and 2: Number of Participants With at Least 50 Percent (%) Reduction (Response) in the OLE Monthly Seizure Count	5 Participants	3 Participants	11 Participants	16 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From OLE baseline (Day 1 of OLE) up to 5 days after last dose of OLE period (5 days + 24 months after start of OLE) (the actual OLE starting time varied for each participant)

Population: Safety open label extension (SAFOLE) analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.

Number of participants with TEAEs and TESAEs were reported. An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A serious AE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, or was medically important. TEAE/TESAE was defined as any AE/SAE occurred at or after the initial administration of study intervention through the day of last dose plus 5 days. TEAEs included serious and non-serious events.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo n=12 Participants During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo n=7 Participants During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=23 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=31 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
OLE Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) TEAEs	6 Participants	6 Participants	16 Participants	17 Participants	—	—	—	—
OLE Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) TESAEs	0 Participants	0 Participants	5 Participants	1 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From OLE baseline (Day 1 of OLE) up to 24 months + 5 days after start of OLE (the actual OLE starting time varied for each participant)

Population: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period. Here 'N' (overall number of participants analyzed) refers to the number of participants with at least 1 postbaseline value for the specified vital sign parameter and 'n' (number analyzed) refers to number of participants evaluable at specified parameter. n=0 indicates that there was no evaluable participant for specified parameter.

TE clinically important changes in vital signs (VS) were pulse rate (PR) greater than (\>)100 beats per min \[bpm\] and with \>30bpm increase from baseline (BL), PR less than (\<)50 bpm and with \>20bpm decrease from BL, systolic blood pressure (SBP) \>140 millimeters of mercury (mmHg) and with \>40mm Hg increase from BL, SBP \<90mmHg and with \>30mmHg decrease from BL), diastolic blood pressure (DBP) \>90mmHg and with \>30mmHg increase from BL, DBP \<50mmHg and with \>20 mmHg decrease from BL, and temperature \>38 degree Celsius(C) and with greater than or equal to (\>=)1degree C increase from BL. TE: post BL value was above upper limit and BL value was below upper limit (example: Normal or Low). Same applied to post BL value being below lower limit with BL value being above lower limit (example: Normal or High). TEVS: VS which occurred as at or after initial administration of study intervention through last dose plus 5 days. Only categories in which at least 1 participant had data were reported.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=1 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=1 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
OLE Period: Cohort 1 and 2: Number of Participants With Treatment-emergent (TE) Clinically Important Changes in Vital Signs PR>100bpm with >30bpm increase from BL	—	—	1 Participants	1 Participants	—	—	—	—
OLE Period: Cohort 1 and 2: Number of Participants With Treatment-emergent (TE) Clinically Important Changes in Vital Signs SBP >140 mm Hg and with >40 mm Hg increase from BL	—	—	1 Participants	—	—	—	—	—
OLE Period: Cohort 1 and 2: Number of Participants With Treatment-emergent (TE) Clinically Important Changes in Vital Signs DBP >90 mm Hg, with >30 mm Hg increase from BL	—	—	1 Participants	—	—	—	—	—

SECONDARY outcome

Timeframe: From OLE baseline (Day 1 of OLE) up to 24 months + 5 days after start of OLE (the actual OLE starting time varied for each subject)

Population: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.

Number of participants with changes in laboratory assessments recorded as TEAE were reported. Laboratory assessments included clinical chemistry, hematology and urinalysis. Postbaseline abnormalities were compared with baseline values: if postbaseline value exceeding the upper limit (with baseline below upper limit) or falling below the lower limit (with baseline above lower limit) was considered treatment-emergent (TE); if baseline values were missing then any postbaseline abnormality was considered TE. TEAE was defined as any AE occurring at or after the initial administration of study intervention through the day of last dose plus 5 days.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo n=12 Participants During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo n=7 Participants During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=23 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=31 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
OLE Period: Cohort 1 and 2: Number of Participants With Changes in Laboratory Assessments Recorded as TEAE Hematology	0 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—
OLE Period: Cohort 1 and 2: Number of Participants With Changes in Laboratory Assessments Recorded as TEAE Chemistry	2 Participants	0 Participants	4 Participants	2 Participants	—	—	—	—
OLE Period: Cohort 1 and 2: Number of Participants With Changes in Laboratory Assessments Recorded as TEAE Urinalysis	0 Participants	0 Participants	2 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90)

Population: Safety analysis set (SAF) included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the double-blind period.

Number of participants with TEAEs and TESAEs were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. A serious AE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via a medicinal product, or was medically important. TEAE/TESAE was defined as any AE/SAE occurred at or after the initial administration of study intervention through the day of last dose plus 5 days. TEAEs included serious and non-serious events.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo n=20 Participants During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo n=9 Participants During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=40 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=41 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
DB Treatment Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) TEAEs	7 Participants	8 Participants	22 Participants	24 Participants	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) TESAEs	0 Participants	1 Participants	1 Participants	2 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90)

Population: Safety analysis set included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the double-blind period. Here 'N' (overall number of participants analyzed) refers to the number of participants with at least 1 postbaseline value for the specified vital sign parameter and 'n' (number analyzed) refers to number of participants evaluable at specified parameter. n=0 indicates that there was no evaluable participant for specified parameter.

Treatment-emergent clinically important changes in vital signs defined as PR \>100 bpm and with \>30 bpm increase from baseline, PR \<50 bpm and with \>20 bpm decrease from baseline, SBP \>140 mm Hg and with \>40 mm Hg increase from baseline, SBP \<90 mm Hg and with \>30 mm Hg decrease from baseline, DBP \>90 mm Hg and with \>30 mm Hg increase from baseline, DBP \<50 mm Hg and with \>20 mm Hg decrease from baseline, temperature \>38 degree C and with \>=1 degree C increase from baseline. TE clinically important changes: if postbaseline value was above upper limit and baseline value was below upper limit (example: Normal or Low). Same applied to postbaseline value being below lower limit with baseline value being above lower limit (example: Normal or High). Only those categories in which at least 1 participant had data were reported in this outcome measure. TE vital signs included vital signs which occurred as at or after initial administration of study intervention through last dose plus 5 days.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo n=1 Participants During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=1 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=2 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
DB Treatment Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Clinically Important Changes in Vital Signs PR >100 bpm, >30 bpm increase from BL	—	—	1 Participants	2 Participants	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Clinically Important Changes in Vital Signs SBP >140 mm Hg; with >40 mm Hg increase from BL	—	—	1 Participants	—	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Clinically Important Changes in Vital Signs DBP >90 mm Hg and with >30 mm Hg increase from BL	1 Participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90)

Population: Safety analysis set included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the double-blind period. Here 'n' (number analyzed) refers to number of participants with at least 1 postbaseline value for the specified parameter.

The ECG parameters analyzed: heart rate, PR interval, RR interval, QRS interval, QT interval, and corrected QT (QTc) interval using the correction methods: Bazett's formula (QTcB), Fridericia's formula (QTcF). TE clinically important changes ECG values (relative to baseline) were defined as heart rate (bpm): \<45 and \>100; PR interval (millisecond \[msec\]): \<120 and \>200; QRS interval (msec): \>120; QTc (msec): \>470 in women and \>450 in men. TE was concluded if the postbaseline value was above the upper limit and the baseline value was below the upper limit (example: Normal or Low). The same applied to the postbaseline value being below the lower limit with the baseline value being above the lower limit (example: Normal or High). TE ECGs: clinically important ECGs which occurred as at or after initial administration of study intervention through last dose plus 5 days. Only categories in which at least 1 participant had data were reported in this outcome measure.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo n=20 Participants During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo n=9 Participants During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=40 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=41 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
DB Treatment Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Clinically Important Changes in Electrocardiogram (ECG) PR Interval (<120 msec)	1 Participants	0 Participants	2 Participants	2 Participants	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Clinically Important Changes in Electrocardiogram (ECG) PR Interval (>200 msec)	0 Participants	1 Participants	2 Participants	2 Participants	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Clinically Important Changes in Electrocardiogram (ECG) QRS Duration (>120 msec)	0 Participants	0 Participants	2 Participants	1 Participants	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Clinically Important Changes in Electrocardiogram (ECG) QTcB Interval (Female) (>470 msec)	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Clinically Important Changes in Electrocardiogram (ECG) QTcB Interval (male) (>450 msec)	0 Participants	0 Participants	1 Participants	2 Participants	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Clinically Important Changes in Electrocardiogram (ECG) QTcF Interval (male) (>450 msec)	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Number of Participants With Treatment-emergent Clinically Important Changes in Electrocardiogram (ECG) Heart Rate >100 beats/min	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90)

Population: Safety analysis set included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the double-blind period.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo n=20 Participants During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo n=9 Participants During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=40 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=41 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
DB Treatment Period: Cohort 1 and 2: Number of Participants With Changes in Laboratory Assessments Recorded as TEAE Hematology	0 Participants	0 Participants	0 Participants	1 Participants	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Number of Participants With Changes in Laboratory Assessments Recorded as TEAE Chemistry	0 Participants	0 Participants	1 Participants	1 Participants	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Number of Participants With Changes in Laboratory Assessments Recorded as TEAE Urinalysis	0 Participants	1 Participants	0 Participants	0 Participants	—	—	—	—

SECONDARY outcome

Timeframe: From DB period Day 1 up to Day 85

Population: FAS included all randomized participants assigned to receive study intervention and had both baseline and postbaseline seizure data.

The percent reduction in the DB monthly seizure rate was defined as 100\*(baseline monthly seizure count minus DB monthly seizure count) divided by (baseline monthly seizure count). The DB monthly seizure count was defined as the total number of observable focal onset seizures occurring during the 12-week DB period, multiplied by 28/XDB, where XDB was the number of days comprising the DB period. A positive percentage change in the double-blind monthly seizure count indicates improvement. Observable focal onset seizures included focal aware seizures with motor signs, focal impaired awareness seizures and focal to bilateral tonic-clonic seizures. Focal aware seizures without motor signs, myoclonic, or other generalized seizures was not counted towards baseline monthly seizure count.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo n=20 Participants During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo n=9 Participants During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=40 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=40 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
Cohort 1 and 2: Percent Reduction in the Double-blind Period Monthly Seizure Rate	23.0 Percent change (reduction) Interval 7.7 to 37.7	10.1 Percent change (reduction) Interval -1.3 to 28.2	16.2 Percent change (reduction) Interval -4.9 to 62.3	30.1 Percent change (reduction) Interval -21.9 to 56.4	—	—	—	—

SECONDARY outcome

Timeframe: From DB period Day 1 up to Day 85

Population: FAS included all randomized participants assigned to receive study intervention and had both baseline and postbaseline seizure data.

Percentage of participants with seizure freedom during DB period was reported. Seizure freedom was defined as having no seizures over the complete DB period.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo n=20 Participants During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo n=9 Participants During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=40 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=40 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
Cohort 1 and 2: Percentage of Participants With Seizure Freedom During Double-blind Period	5.0 Percentage of participants	0.0 Percentage of participants	2.5 Percentage of participants	7.5 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: From DB period Day 1 up to Day 85

Population: FAS included all randomized participants assigned to receive study intervention and had both baseline and postbaseline seizure data.

Percentage of participants who achieved a \>50% reduction (response) in the DB monthly seizure count relative to baseline monthly seizure count during the DB period was reported. The baseline monthly seizure count was defined as the number of observable focal onset seizures occurred during the 8-week baseline period (Day -56 to -1), multiplied by 28/XBL, where XBL was the number of days comprising the participants baseline period. Observable focal onset seizures included focal aware seizures with motor signs, focal impaired awareness seizures and focal to bilateral tonic-clonic seizures. Focal aware seizures without motor signs, myoclonic, or other generalized seizures was not counted towards baseline monthly seizure count.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo n=20 Participants During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo n=9 Participants During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=40 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=40 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
Cohort 1 and 2: Percentage of Participants Who Achieved a More Than (>) 50 Percent (%) Reduction (Response) in Double-blind Monthly Seizure Count Relative to Baseline Monthly Seizure Count	15.0 Percentage of participants	22.2 Percentage of participants	32.5 Percentage of participants	30.0 Percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Day 1: 2 hours post-dose, Days 29: pre-dose and 1 hour post-dose, Day 57: pre-dose and Day 85: post-dose/Early withdrawal (EW)

Population: Pharmacokinetic (PK) set: all randomized participants who received at least 1 dose of JNJ-40411813 and had at least 1 valid blood sample drawn for PK analysis and excluded samples with below lower limit of quantification or samples with inconsistent date/time or samples with previous dose date/time incomplete or samples with concentration less than (\<) 10 nanograms per milliliter (ng/mL).

DB treatment period: Cohort 1 and 2: plasma concentration of JNJ-40411813 and its metabolites (M30, M45 and M47) were reported. The concentrations of JNJ-40411813 and its metabolites (M30, M45 and M47) were measured using a validated, specific, and sensitive liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1 and 2 placebo arms. Here, 'n' (number analyzed)=number of participants evaluable at each specified category.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo n=18 Participants During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo n=17 Participants During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=22 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=22 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 JNJ: Day 1: 2 hours post-dose	228 Nanograms per milliliter Standard Deviation 116	212 Nanograms per milliliter Standard Deviation 113	268 Nanograms per milliliter Standard Deviation 139	379 Nanograms per milliliter Standard Deviation 192	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 JNJ: Day 29: pre-dose	272 Nanograms per milliliter Standard Deviation 178	506 Nanograms per milliliter Standard Deviation 283	356 Nanograms per milliliter Standard Deviation 192	797 Nanograms per milliliter Standard Deviation 412	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 JNJ: Day 29: 1 hour post-dose	403 Nanograms per milliliter Standard Deviation 285	633 Nanograms per milliliter Standard Deviation 289	560 Nanograms per milliliter Standard Deviation 281	958 Nanograms per milliliter Standard Deviation 465	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 JNJ: Day 57: pre-dose	276 Nanograms per milliliter Standard Deviation 205	516 Nanograms per milliliter Standard Deviation 216	360 Nanograms per milliliter Standard Deviation 187	687 Nanograms per milliliter Standard Deviation 248	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 JNJ: Day 85:post-dose/EW	354 Nanograms per milliliter Standard Deviation 385	515 Nanograms per milliliter Standard Deviation 267	440 Nanograms per milliliter Standard Deviation 343	785 Nanograms per milliliter Standard Deviation 394	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M30: Day 1: 2 hours post-dose	20.8 Nanograms per milliliter Standard Deviation 11.7	12.6 Nanograms per milliliter Standard Deviation 8.85	21.5 Nanograms per milliliter Standard Deviation 15.5	24.8 Nanograms per milliliter Standard Deviation 20.4	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M30: Day 29: pre-dose	326 Nanograms per milliliter Standard Deviation 116	294 Nanograms per milliliter Standard Deviation 119	232 Nanograms per milliliter Standard Deviation 109	239 Nanograms per milliliter Standard Deviation 100	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M30: Day 29: 1 hour post-dose	295 Nanograms per milliliter Standard Deviation 108	275 Nanograms per milliliter Standard Deviation 119	211 Nanograms per milliliter Standard Deviation 105	220 Nanograms per milliliter Standard Deviation 116	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M30: Day 57: pre-dose	291 Nanograms per milliliter Standard Deviation 150	289 Nanograms per milliliter Standard Deviation 135	219 Nanograms per milliliter Standard Deviation 108	277 Nanograms per milliliter Standard Deviation 111	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M30: Day 85:post-dose/EW	299 Nanograms per milliliter Standard Deviation 123	248 Nanograms per milliliter Standard Deviation 121	191 Nanograms per milliliter Standard Deviation 122	274 Nanograms per milliliter Standard Deviation 93.7	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M45: Day 1: 2 hours post-dose	58.9 Nanograms per milliliter Standard Deviation 24.2	45.1 Nanograms per milliliter Standard Deviation 21.6	49.8 Nanograms per milliliter Standard Deviation 31.0	52.5 Nanograms per milliliter Standard Deviation 22.5	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M45: Day 29: pre-dose	107 Nanograms per milliliter Standard Deviation 60.1	122 Nanograms per milliliter Standard Deviation 64.9	65.4 Nanograms per milliliter Standard Deviation 45.7	76.3 Nanograms per milliliter Standard Deviation 35.2	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M45: Day 29: 1 hour post-dose	106 Nanograms per milliliter Standard Deviation 54.8	115 Nanograms per milliliter Standard Deviation 56.0	68.9 Nanograms per milliliter Standard Deviation 36.3	74.5 Nanograms per milliliter Standard Deviation 28.4	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M45: Day 57: pre-dose	103 Nanograms per milliliter Standard Deviation 55.7	113 Nanograms per milliliter Standard Deviation 56.8	63.6 Nanograms per milliliter Standard Deviation 42.9	76.0 Nanograms per milliliter Standard Deviation 32.1	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M45: Day 85: post-dose/EW	101 Nanograms per milliliter Standard Deviation 57.9	113 Nanograms per milliliter Standard Deviation 64.2	62.3 Nanograms per milliliter Standard Deviation 41.6	73.5 Nanograms per milliliter Standard Deviation 40.1	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M47: Day 1: 2 hours post-dose	25.8 Nanograms per milliliter Standard Deviation 14.0	19.4 Nanograms per milliliter Standard Deviation 10.5	34.7 Nanograms per milliliter Standard Deviation 19.7	36.8 Nanograms per milliliter Standard Deviation 20.3	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M47: Day 29: pre-dose	51.9 Nanograms per milliliter Standard Deviation 36.1	81.6 Nanograms per milliliter Standard Deviation 41.5	63.7 Nanograms per milliliter Standard Deviation 31.7	93.8 Nanograms per milliliter Standard Deviation 42.9	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M47: Day 29: 1 hour post-dose	53.5 Nanograms per milliliter Standard Deviation 30.5	77.3 Nanograms per milliliter Standard Deviation 36.4	69.7 Nanograms per milliliter Standard Deviation 29.2	90.1 Nanograms per milliliter Standard Deviation 45.3	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M47: Day 57: pre-dose	53.3 Nanograms per milliliter Standard Deviation 47.5	84.0 Nanograms per milliliter Standard Deviation 41.7	61.7 Nanograms per milliliter Standard Deviation 26.2	94.3 Nanograms per milliliter Standard Deviation 30.1	—	—	—	—
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M47: Day 85: post-dose/EW	52.9 Nanograms per milliliter Standard Deviation 58.8	97.4 Nanograms per milliliter Standard Deviation 27.8	60.2 Nanograms per milliliter Standard Deviation 37.8	100 Nanograms per milliliter Standard Deviation 39.9	—	—	—	—

SECONDARY outcome

Timeframe: Day 1: pre-dose and 2 hours post-dose, Day 29: pre-dose and 1 hour post-dose, Day 57: pre-dose and Day 85: post-dose/Early withdrawal

Population: PK set was used. Here, 'N' (overall number of participants analyzed)=number of participants evaluable for this OM; 'n' (number analyzed) = number of participants evaluable at each specified category.

DB treatment period: Cohort 1 and 2: plasma concentration of AED: levetiracetam were reported. The concentrations of levetiracetam were measured using a validated, specific, and sensitive LC-MS/MS method.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo n=9 Participants During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo n=18 Participants During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=11 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=22 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced n=2 Participants During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced n=5 Participants During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced n=15 Participants During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced n=13 Participants During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of AED: Levetiracetam Day 1: pre-dose	9443 Nanograms per milliliter Standard Deviation 7244	12719 Nanograms per milliliter Standard Deviation 8734	9664 Nanograms per milliliter Standard Deviation 4210	10836 Nanograms per milliliter Standard Deviation 7328	28950 Nanograms per milliliter Standard Deviation 17748	23190 Nanograms per milliliter Standard Deviation 26095	18844 Nanograms per milliliter Standard Deviation 16282	11648 Nanograms per milliliter Standard Deviation 11371
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of AED: Levetiracetam Day 1: 2 hours post-dose	28926 Nanograms per milliliter Standard Deviation 16762	29782 Nanograms per milliliter Standard Deviation 19304	28859 Nanograms per milliliter Standard Deviation 15629	21593 Nanograms per milliliter Standard Deviation 13973	35450 Nanograms per milliliter Standard Deviation 2475	27300 Nanograms per milliliter Standard Deviation 11876	24638 Nanograms per milliliter Standard Deviation 13687	22894 Nanograms per milliliter Standard Deviation 13656
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of AED: Levetiracetam Day 29: pre-dose	12420 Nanograms per milliliter Standard Deviation 9133	17583 Nanograms per milliliter Standard Deviation 11268	16546 Nanograms per milliliter Standard Deviation 13963	8926 Nanograms per milliliter Standard Deviation 6665	14400 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	7137 Nanograms per milliliter Standard Deviation 247	17369 Nanograms per milliliter Standard Deviation 11404	7651 Nanograms per milliliter Standard Deviation 5505
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of AED: Levetiracetam Day 29: 1 hour post-dose	27510 Nanograms per milliliter Standard Deviation 24608	28709 Nanograms per milliliter Standard Deviation 14885	30999 Nanograms per milliliter Standard Deviation 15392	24383 Nanograms per milliliter Standard Deviation 23858	28050 Nanograms per milliliter Standard Deviation 18031	27950 Nanograms per milliliter Standard Deviation 3041	22102 Nanograms per milliliter Standard Deviation 14695	30887 Nanograms per milliliter Standard Deviation 16987
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of AED: Levetiracetam Day 57: pre-dose	14066 Nanograms per milliliter Standard Deviation 11366	12927 Nanograms per milliliter Standard Deviation 6140	12992 Nanograms per milliliter Standard Deviation 8088	10403 Nanograms per milliliter Standard Deviation 8785	9680 Nanograms per milliliter Standard Deviation 10493	23900 Nanograms per milliliter Standard Deviation 18950	18090 Nanograms per milliliter Standard Deviation 11580	6786 Nanograms per milliliter Standard Deviation 8500
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of AED: Levetiracetam Day 85: post-dose/EW	19834 Nanograms per milliliter Standard Deviation 19271	23461 Nanograms per milliliter Standard Deviation 20193	19671 Nanograms per milliliter Standard Deviation 14617	15451 Nanograms per milliliter Standard Deviation 12004	40000 Nanograms per milliliter Standard Deviation 2970	22950 Nanograms per milliliter Standard Deviation 17466	20680 Nanograms per milliliter Standard Deviation 15826	16053 Nanograms per milliliter Standard Deviation 22950

SECONDARY outcome

Timeframe: Day 1: pre-dose and 2 hours post-dose, Days 29: pre-dose and 1 hour post-dose, Day 57: pre-dose and Day 85: post-dose/Early withdrawal

Population: PK set was used for the analysis. Here, 'N' (overall number of participants analyzed)=number of participants evaluable for this OM; 'n' (number analyzed) = number of participants evaluable at each specified category. Here, N=0 signifies that no participant received brivaracetam; n=0 in arm 'DB: Cohort 2: Placebo Non-induced' at timepoint 'Day 57: pre-dose' signifies that no participant was available at specific visit and thus, no data was collected and analyzed.

DB treatment period: Cohort 1 and 2: plasma concentration of AED: brivaracetam were reported. The concentrations of brivaracetam were measured using a validated, specific, and sensitive LC-MS/MS method.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced n=1 Participants During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced n=1 Participants During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced n=2 Participants During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced n=11 Participants During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of AED: Brivaracetam Day 1: pre-dose	—	—	—	—	556 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	1040 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	1604 Nanograms per milliliter Standard Deviation 1394	838 Nanograms per milliliter Standard Deviation 622
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of AED: Brivaracetam Day 1: 2 hours post-dose	—	—	—	—	2150 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	2970 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	2320 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	2540 Nanograms per milliliter Standard Deviation 1659
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of AED: Brivaracetam Day 29: pre-dose	—	—	—	—	750 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	991 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	2495 Nanograms per milliliter Standard Deviation 1619	734 Nanograms per milliliter Standard Deviation 658
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of AED: Brivaracetam Day 29: 1 hour post-dose	—	—	—	—	3230 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	2950 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	3930 Nanograms per milliliter Standard Deviation 85	2343 Nanograms per milliliter Standard Deviation 1149
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of AED: Brivaracetam Day 57: pre-dose	—	—	—	—	—	1020 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	950 Nanograms per milliliter Standard Deviation 284	709 Nanograms per milliliter Standard Deviation 719
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of AED: Brivaracetam Day 85: post-dose/EW	—	—	—	—	743 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	3330 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	2499 Nanograms per milliliter Standard Deviation 2547	1258 Nanograms per milliliter Standard Deviation 1444

SECONDARY outcome

Timeframe: Pre-dose: Day 1, Days 29, and Day 57

Population: PK set was used for the analysis. Here, 'N' (overall number of participants analyzed)=number of participants evaluable for this OM; 'n' (number analyzed) = number of participants evaluable at each specified category. Here, N=0 signifies that non-induced arms were not applicable to this outcome measure as carbamazepine itself is a CYP3A4-inducing AED.

DB treatment period: Cohort 1 and 2: plasma concentration of AED: carbamazepine were reported. The concentrations of carbamazepine were measured using a validated, specific, and sensitive LC-MS/MS method.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=5 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=12 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced n=2 Participants During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced n=12 Participants During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of AED: Carbamazepine Day 1: pre-dose	—	—	7618 Nanograms per milliliter Standard Deviation 3305	5071 Nanograms per milliliter Standard Deviation 3773	—	7450 Nanograms per milliliter Standard Deviation 1966	—	7431 Nanograms per milliliter Standard Deviation 1214
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of AED: Carbamazepine Day 29: pre-dose	—	—	8270 Nanograms per milliliter Standard Deviation 1481	4713 Nanograms per milliliter Standard Deviation 4198	—	6990 Nanograms per milliliter Standard Deviation 269	—	6476 Nanograms per milliliter Standard Deviation 1895
DB Treatment Period: Cohort 1 and 2: Plasma Concentration of AED: Carbamazepine Day 57: pre-dose	—	—	7943 Nanograms per milliliter Standard Deviation 1975	4526 Nanograms per milliliter Standard Deviation 2765	—	6390 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	—	5573 Nanograms per milliliter Standard Deviation 915

SECONDARY outcome

Timeframe: Cohort 1:OLE visit 2 (1 month post OLE baseline[BL]), OLE visit 3 (2 months post OLE BL), OLE visit 4 to 7 (up to 1year post OLE BL);Cohort 2:OLE visit 2 (1 month post OLE BL), OLE visit 3 (2 months post OLE BL), OLE visit 4 to 5 (up to 1year post OLE BL)

Population: PK set was used for the analysis. Here, n=0 signifies that none of the participants were evaluable for assessment in the specified arm for specified time point. Here, 'n' (number analyzed)=number of participants evaluable at each specified category.

OLE period: Cohort 1 and 2: plasma concentration of JNJ-40411813 and its metabolites (M30, M45 and M47) were reported. The concentrations of JNJ-40411813 and its metabolites (M30, M45 and M47) were measured using a validated, specific, and sensitive LC-MS/MS method. Data for this outcome measure was not planned to be collected and analyzed for Cohort 1 and 2 placebo arms. OLE baseline was Day 1 of OLE period.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo n=8 Participants During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo n=11 Participants During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=15 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=16 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 JNJ-40411813: OLE visit 4	311 Nanograms per milliliter Standard Deviation 207	539 Nanograms per milliliter Standard Deviation 147	392 Nanograms per milliliter Standard Deviation 288	921 Nanograms per milliliter Standard Deviation 464	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 JNJ-40411813: OLE visit 2	272 Nanograms per milliliter Standard Deviation 233	524 Nanograms per milliliter Standard Deviation 149	372 Nanograms per milliliter Standard Deviation 241	930 Nanograms per milliliter Standard Deviation 370	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 JNJ-40411813: OLE visit 3	280 Nanograms per milliliter Standard Deviation 217	515 Nanograms per milliliter Standard Deviation 172	333 Nanograms per milliliter Standard Deviation 157	993 Nanograms per milliliter Standard Deviation 361	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 JNJ-40411813: OLE visit 5	285 Nanograms per milliliter Standard Deviation 241	532 Nanograms per milliliter Standard Deviation 105	315 Nanograms per milliliter Standard Deviation 197	1610 Nanograms per milliliter Standard Deviation 255	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 JNJ-40411813: OLE visit 6	442 Nanograms per milliliter Standard Deviation 493	—	349 Nanograms per milliliter Standard Deviation 214	—	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 JNJ-40411813: OLE visit 7	330 Nanograms per milliliter Standard Deviation 252	—	385 Nanograms per milliliter Standard Deviation 269	—	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M30: OLE visit 2	298 Nanograms per milliliter Standard Deviation 91.3	316 Nanograms per milliliter Standard Deviation 129	225 Nanograms per milliliter Standard Deviation 136	249 Nanograms per milliliter Standard Deviation 94.9	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M30: OLE visit 3	293 Nanograms per milliliter Standard Deviation 135	356 Nanograms per milliliter Standard Deviation 113	224 Nanograms per milliliter Standard Deviation 172	234 Nanograms per milliliter Standard Deviation 73.7	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M30: OLE visit 4	265 Nanograms per milliliter Standard Deviation 120	333 Nanograms per milliliter Standard Deviation 125	263 Nanograms per milliliter Standard Deviation 161	251 Nanograms per milliliter Standard Deviation 54.6	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M30: OLE visit 5	301 Nanograms per milliliter Standard Deviation 154	349 Nanograms per milliliter Standard Deviation 223	259 Nanograms per milliliter Standard Deviation 169	274 Nanograms per milliliter Standard Deviation 65.1	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M30: OLE visit 6	286 Nanograms per milliliter Standard Deviation 91.8	—	236 Nanograms per milliliter Standard Deviation 141	—	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M30: OLE visit 7	364 Nanograms per milliliter Standard Deviation 64.7	—	265 Nanograms per milliliter Standard Deviation 115	—	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M45: OLE visit 2	85.3 Nanograms per milliliter Standard Deviation 37.8	101 Nanograms per milliliter Standard Deviation 34.9	57.7 Nanograms per milliliter Standard Deviation 29.2	87.4 Nanograms per milliliter Standard Deviation 27.8	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M45: OLE visit 3	93.8 Nanograms per milliliter Standard Deviation 41.2	101 Nanograms per milliliter Standard Deviation 54.5	56.0 Nanograms per milliliter Standard Deviation 28.0	85.5 Nanograms per milliliter Standard Deviation 29.0	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M45: OLE visit 4	81.1 Nanograms per milliliter Standard Deviation 40.9	112 Nanograms per milliliter Standard Deviation 77.0	64.0 Nanograms per milliliter Standard Deviation 32.4	84.0 Nanograms per milliliter Standard Deviation 30.7	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M45: OLE visit 5	75.7 Nanograms per milliliter Standard Deviation 45.2	89.2 Nanograms per milliliter Standard Deviation 9.69	65.7 Nanograms per milliliter Standard Deviation 38.0	91.7 Nanograms per milliliter Standard Deviation 6.22	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M45: OLE visit 6	72.1 Nanograms per milliliter Standard Deviation 49.8	—	61.6 Nanograms per milliliter Standard Deviation 41.9	—	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M45: OLE visit 7	71.8 Nanograms per milliliter Standard Deviation 51.9	—	59.3 Nanograms per milliliter Standard Deviation 28.4	—	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M47: OLE visit 2	59.3 Nanograms per milliliter Standard Deviation 71.0	98.9 Nanograms per milliliter Standard Deviation 34.6	58.0 Nanograms per milliliter Standard Deviation 31.4	107 Nanograms per milliliter Standard Deviation 30.8	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M47: OLE visit 3	52.8 Nanograms per milliliter Standard Deviation 58.2	81.7 Nanograms per milliliter Standard Deviation 28.6	58.7 Nanograms per milliliter Standard Deviation 24.5	122 Nanograms per milliliter Standard Deviation 45.4	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M47: OLE visit 4	59.1 Nanograms per milliliter Standard Deviation 66.0	80.3 Nanograms per milliliter Standard Deviation 12.4	65.6 Nanograms per milliliter Standard Deviation 34.1	118 Nanograms per milliliter Standard Deviation 47.1	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M47: OLE visit 5	62.8 Nanograms per milliliter Standard Deviation 79.1	78.0 Nanograms per milliliter Standard Deviation 13.9	57.6 Nanograms per milliliter Standard Deviation 25.1	157 Nanograms per milliliter Standard Deviation 58.0	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M47: OLE visit 6	70.1 Nanograms per milliliter Standard Deviation 90.8	—	66.9 Nanograms per milliliter Standard Deviation 44.9	—	—	—	—	—
OLE Period: Cohort 1 and 2: Plasma Concentration of JNJ-40411813 and Its Metabolites: M30, M45 and M47 M47: OLE visit 7	70.3 Nanograms per milliliter Standard Deviation 80.7	—	69.8 Nanograms per milliliter Standard Deviation 30.4	—	—	—	—	—

SECONDARY outcome

Timeframe: OLE visit 2: 1st month; OLE visit 3: 2nd month

OLE period: Cohort 1 and 2: plasma concentration of AED: levetiracetam were reported. The concentrations of levetiracetam were measured using a validated, specific, and sensitive LC-MS/MS method.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo n=2 Participants During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo n=8 Participants During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=4 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=14 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced n=2 Participants During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced n=1 Participants During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced n=9 Participants During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced n=7 Participants During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
OLE Period: Cohort 1 and 2: Plasma Concentration of AED: Levetiracetam OLE visit 2	12980 Nanograms per milliliter Standard Deviation 6817	15787 Nanograms per milliliter Standard Deviation 6029	9752 Nanograms per milliliter Standard Deviation 2937	11719 Nanograms per milliliter Standard Deviation 7661	15000 Nanograms per milliliter Standard Deviation 849	7410 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	15406 Nanograms per milliliter Standard Deviation 7870	11929 Nanograms per milliliter Standard Deviation 13102
OLE Period: Cohort 1 and 2: Plasma Concentration of AED: Levetiracetam OLE visit 3	10400 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	15734 Nanograms per milliliter Standard Deviation 7392	8310 Nanograms per milliliter Standard Deviation 3019	10643 Nanograms per milliliter Standard Deviation 7986	12100 Nanograms per milliliter Standard Deviation 1273	29100 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	13760 Nanograms per milliliter Standard Deviation 4972	5068 Nanograms per milliliter Standard Deviation 5040

SECONDARY outcome

Timeframe: OLE visit 2: 1st month; OLE visit 3: 2nd month

Population: PK set was used. 'N' (overall number of participants analyzed)=number of participants evaluable for this OM; 'n' (number analyzed)=number of participants evaluable at each specified category. Cohort (C) 1: N=0=no participant received brivaracetam; C 2: N=0=no participant was available and thus, no data was collected and analyzed; n=0 in arm 'OLE: C 2: JNJ-40411813 Non-induced' timepoint 'OLE visit 3'= no participant was available at specific visit and thus, no data was collected and analyzed.

OLE period: Cohort 1 and 2: plasma concentration of AED: brivaracetam were reported. The concentrations of brivaracetam were measured using a validated, specific, and sensitive LC-MS/MS method.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced n=1 Participants During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced n=1 Participants During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced n=8 Participants During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
OLE Period: Cohort 1 and 2: Plasma Concentration of AED: Brivaracetam OLE visit 2	—	—	—	—	—	1030 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	611 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	834 Nanograms per milliliter Standard Deviation 707
OLE Period: Cohort 1 and 2: Plasma Concentration of AED: Brivaracetam OLE visit 3	—	—	—	—	—	1010 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	—	694 Nanograms per milliliter Standard Deviation 746

SECONDARY outcome

Timeframe: OLE visit 2: 1st month; OLE visit 3: 2nd month

Population: PK set used. 'N' (overall number of participants analyzed)=number of participants evaluable for this OM; 'n' (number analyzed) = number of participants evaluable at each specified category. N=0 of all non-induced arms signifies that these arms were not applicable to this outcome measure as carbamazepine itself is a CYP3A4-inducing AED; For 'OLE: Cohort 2: Placebo Followed by JNJ-40411813 Induced' arm: N=0 signifies that no participant was available and thus, no data was collected and analyzed.

OLE period: Cohort 1 and 2: plasma concentration of AED: carbamazepine were reported. The concentrations of carbamazepine were measured using a validated, specific, and sensitive LC-MS/MS method.

Outcome measures

Outcome measures
Measure	DB: Cohort 1: Placebo During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=1 Participants During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=5 Participants During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study drug due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Non-induced During DB period, participants not treated with EIAEDs (non-induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo Induced During DB period, participants treated with EIAEDs (induced) received placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Non-induced During DB period, participants not treated with EIAEDs (non-induced) received 100 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 Induced n=5 Participants During DB period, participants treated with EIAEDs (induced) received 200 mg JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform the end-of-study for DB period visit (last visit for last participant; Day 85) or enter the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were follow-up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).
OLE Period: Plasma Concentration of AED: Carbamazepine OLE visit 2	—	—	5970 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	3780 Nanograms per milliliter Standard Deviation 2604	—	—	—	6266 Nanograms per milliliter Standard Deviation 1370
OLE Period: Plasma Concentration of AED: Carbamazepine OLE visit 3	—	—	5780 Nanograms per milliliter Standard Deviation NA Here, 'NA' signifies that standard deviation could not be estimated as only 1 participant was analyzed.	5814 Nanograms per milliliter Standard Deviation 4617	—	—	—	6638 Nanograms per milliliter Standard Deviation 1868

Adverse Events

DB: Cohort 1: Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

DB: Cohort 2: JNJ-40411813

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

DB: Cohort 1: JNJ-40411813

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

DB: Cohort 2: Placebo

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

OLE: Cohort 1: Placebo Followed by JNJ-40411813

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

OLE: Cohort 1: JNJ-40411813 Followed by JNJ-40411813

Serious events: 5 serious events

Other events: 12 other events

Deaths: 0 deaths

OLE: Cohort 2: Placebo Followed by JNJ-40411813

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

OLE: Cohort 2: JNJ-40411813 Followed by JNJ-40411813

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DB: Cohort 1: Placebo n=20 participants at risk During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=41 participants at risk During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=40 participants at risk During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo n=9 participants at risk During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	OLE: Cohort 1: Placebo Followed by JNJ-40411813 n=12 participants at risk During OLE period, cohort 1 participants who had received placebo during the DB period received JNJ-40411813 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) from Day 1 of OLE up to 2 years. Induced participants (with EIAEDs) received JNJ-40411813 100 mg BID, and non-induced participants (without EIAEDs) received JNJ-40411813 50 mg BID. The dose could be increased at the second visit (Month 1) to 200 mg JNJ-40411813 BID for induced participants (with EIAEDs) and 100 mg JNJ-40411813 BID for non-induced participants (without EIAEDs).	OLE: Cohort 1: JNJ-40411813 Followed by JNJ-40411813 n=23 participants at risk During OLE period, cohort 1 participants who had received JNJ-40411813 during the DB period continued to receive JNJ-40411813 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) from Day 1 of OLE up to 2 years. Induced participants (with EIAEDs) received JNJ-40411813 100 mg BID, and non-induced participants (without EIAEDs) received JNJ-40411813 50 mg BID. The dose could be increased at the second visit (Month1) to 200 mg JNJ-40411813 BID for induced participants (with EIAEDs) and 100 mg JNJ-40411813 BID for non-induced participants (without EIAEDs).	OLE: Cohort 2: Placebo Followed by JNJ-40411813 n=7 participants at risk During the OLE period, cohort 2 participants who had received placebo during the DB period received JNJ-40411813 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) from Day 1 of OLE up to 2 years. Participants started with JNJ-40411813 100 mg BID. Induced participants (with EIAEDs) had their dose increased to JNJ-40411813 200 mg BID on Day 8 of the OLE. Non-induced participants (without EIAEDs) continued with JNJ-40411813 100 mg BID.	OLE: Cohort 2: JNJ-40411813 Followed by JNJ-40411813 n=31 participants at risk During OLE period, cohort 2 participants who had received JNJ-40411813 during the DB period continued to receive JNJ-40411813 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) from Day 1 of OLE up to 2 years. Participants started with JNJ-40411813 100 mg BID. Induced participants (with EIAEDs) had their dose increased to JNJ-40411813 200 mg BID on Day 8 of the OLE. Non-induced participants (without EIAEDs) continued with JNJ-40411813 100 mg BID.
Injury, poisoning and procedural complications Cervical Vertebral Fracture	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	2.4% 1/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Injury, poisoning and procedural complications Head Injury	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	3.2% 1/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Injury, poisoning and procedural complications Limb Traumatic Amputation	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	2.5% 1/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary Tumour Benign	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	2.4% 1/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Nervous system disorders Change in Seizure Presentation	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	11.1% 1/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	4.3% 1/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Nervous system disorders Epilepsy	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	4.3% 1/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Nervous system disorders Seizure	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	4.3% 1/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Nervous system disorders Status Epilepticus	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	4.3% 1/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Respiratory, thoracic and mediastinal disorders Pulmonary Mass	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	4.3% 1/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.

Other adverse events

Other adverse events
Measure	DB: Cohort 1: Placebo n=20 participants at risk During double-blind (DB) period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally twice a day (BID) from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the open-label extension (OLE) period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: JNJ-40411813 n=41 participants at risk During DB period, participants were randomized to receive JNJ-40411813 200 mg or 100 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 200 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 100 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 1: JNJ-40411813 n=40 participants at risk During DB period, participants were randomized to receive JNJ-40411813 100 milligrams (mg) or 50 mg tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants treated with EIAEDs (induced) received 100 mg of JNJ-40411813 and participants not treated with EIAEDs (non-induced) received 50 mg of JNJ-40411813. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continued DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	DB: Cohort 2: Placebo n=9 participants at risk During DB period, participants were randomized to receive placebo matching to JNJ-40411813 tablet orally BID from Day 1 up to Day 85 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) on Days 1, 29, and 57. Participants were screened every 4 weeks for monthly seizure counts up to Week 12. Participants who had exceeded their pre-randomization monthly seizure count had the option to discontinue the study treatment due to lack of efficacy and perform the end-of-study/early withdrawal visit, continue DB treatment, or enter the OLE period. Participants who had not exceeded the pre-randomization seizure count continued the DB treatment period through Week 12 and had the option to perform DB period end-of-study visit (last visit for last participant; Day 85) or entered the OLE period. Participants who continued treatment to the end of the DB period (Week 12) and were not elected to participate in the OLE were followed up for safety up to 2 weeks after the last dose of study treatment (up to Week 14).	OLE: Cohort 1: Placebo Followed by JNJ-40411813 n=12 participants at risk During OLE period, cohort 1 participants who had received placebo during the DB period received JNJ-40411813 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) from Day 1 of OLE up to 2 years. Induced participants (with EIAEDs) received JNJ-40411813 100 mg BID, and non-induced participants (without EIAEDs) received JNJ-40411813 50 mg BID. The dose could be increased at the second visit (Month 1) to 200 mg JNJ-40411813 BID for induced participants (with EIAEDs) and 100 mg JNJ-40411813 BID for non-induced participants (without EIAEDs).	OLE: Cohort 1: JNJ-40411813 Followed by JNJ-40411813 n=23 participants at risk During OLE period, cohort 1 participants who had received JNJ-40411813 during the DB period continued to receive JNJ-40411813 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) from Day 1 of OLE up to 2 years. Induced participants (with EIAEDs) received JNJ-40411813 100 mg BID, and non-induced participants (without EIAEDs) received JNJ-40411813 50 mg BID. The dose could be increased at the second visit (Month1) to 200 mg JNJ-40411813 BID for induced participants (with EIAEDs) and 100 mg JNJ-40411813 BID for non-induced participants (without EIAEDs).	OLE: Cohort 2: Placebo Followed by JNJ-40411813 n=7 participants at risk During the OLE period, cohort 2 participants who had received placebo during the DB period received JNJ-40411813 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) from Day 1 of OLE up to 2 years. Participants started with JNJ-40411813 100 mg BID. Induced participants (with EIAEDs) had their dose increased to JNJ-40411813 200 mg BID on Day 8 of the OLE. Non-induced participants (without EIAEDs) continued with JNJ-40411813 100 mg BID.	OLE: Cohort 2: JNJ-40411813 Followed by JNJ-40411813 n=31 participants at risk During OLE period, cohort 2 participants who had received JNJ-40411813 during the DB period continued to receive JNJ-40411813 along with previously prescribed AEDs (one of which must include levetiracetam or brivaracetam) from Day 1 of OLE up to 2 years. Participants started with JNJ-40411813 100 mg BID. Induced participants (with EIAEDs) had their dose increased to JNJ-40411813 200 mg BID on Day 8 of the OLE. Non-induced participants (without EIAEDs) continued with JNJ-40411813 100 mg BID.
Injury, poisoning and procedural complications Arthropod Bite	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	11.1% 1/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Injury, poisoning and procedural complications Contusion	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	4.3% 1/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	14.3% 1/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	3.2% 1/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Injury, poisoning and procedural complications Fall	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	4.3% 1/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	14.3% 1/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Injury, poisoning and procedural complications Head Injury	5.0% 1/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	2.4% 1/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	2.5% 1/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Injury, poisoning and procedural complications Ligament Sprain	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	14.3% 1/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	3.2% 1/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Injury, poisoning and procedural complications Wound	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	8.3% 1/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Investigations Aspartate Aminotransferase Increased	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	2.4% 1/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	8.3% 1/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	4.3% 1/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Investigations Blood Chloride Increased	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	8.3% 1/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Investigations Blood Creatine Phosphokinase Increased	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	2.5% 1/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	8.3% 1/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	8.7% 2/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	8.3% 1/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Musculoskeletal and connective tissue disorders Joint Swelling	5.0% 1/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Musculoskeletal and connective tissue disorders Muscle Contracture	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	14.3% 1/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Nervous system disorders Dizziness	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	4.9% 2/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	2.5% 1/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	42.9% 3/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Nervous system disorders Dizziness Postural	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	7.3% 3/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	2.5% 1/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	4.3% 1/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	14.3% 1/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Ear and labyrinth disorders Vertigo	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	12.2% 5/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	11.1% 1/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	4.3% 1/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	14.3% 1/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Eye disorders Diplopia	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	2.5% 1/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	4.3% 1/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	14.3% 1/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Eye disorders Vision Blurred	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	8.3% 1/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	2.4% 1/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	14.3% 1/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	3.2% 1/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Gastrointestinal disorders Constipation	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	11.1% 1/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Gastrointestinal disorders Diarrhoea	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	5.0% 2/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	8.3% 1/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	3.2% 1/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Gastrointestinal disorders Dyspepsia	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	11.1% 1/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	5.0% 1/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Gastrointestinal disorders Vomiting	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	7.5% 3/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	4.3% 1/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
General disorders Fatigue	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	2.4% 1/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	5.0% 2/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	8.3% 1/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	13.0% 3/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
General disorders Gait Disturbance	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	2.5% 1/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	8.3% 1/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
General disorders Malaise	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	5.0% 2/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Infections and infestations Covid-19	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	5.0% 2/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	16.7% 2/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	13.0% 3/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	3.2% 1/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Infections and infestations Nasopharyngitis	10.0% 2/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	2.4% 1/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	5.0% 2/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	17.4% 4/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	6.5% 2/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Infections and infestations Respiratory Tract Infection Viral	5.0% 1/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	2.5% 1/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Nervous system disorders Dysarthria	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	8.3% 1/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Nervous system disorders Headache	5.0% 1/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	9.8% 4/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	5.0% 2/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	8.3% 1/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	13.0% 3/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	6.5% 2/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Nervous system disorders Memory Impairment	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	8.3% 1/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Nervous system disorders Migraine	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	14.3% 1/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Nervous system disorders Seizure	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	5.0% 2/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Nervous system disorders Somnolence	10.0% 2/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	7.3% 3/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	7.5% 3/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	11.1% 1/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	4.3% 1/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	28.6% 2/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	3.2% 1/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Nervous system disorders Syncope	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	11.1% 1/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	4.3% 1/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Nervous system disorders Tremor	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	5.0% 2/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Psychiatric disorders Insomnia	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	2.4% 1/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	11.1% 1/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	4.3% 1/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	3.2% 1/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Psychiatric disorders Suicidal Ideation	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	11.1% 1/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Renal and urinary disorders Haematuria	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	11.1% 1/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Respiratory, thoracic and mediastinal disorders Choking	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	11.1% 1/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	11.1% 1/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Skin and subcutaneous tissue disorders Rash	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	11.1% 1/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	3.2% 1/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.
Vascular disorders Hypertension	0.00% 0/20 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	2.4% 1/41 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/40 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/9 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/12 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	4.3% 1/23 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	0.00% 0/7 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.	9.7% 3/31 • DB arms: From DB period start (Day 1) up to 5 days after last dose of DB period (up to Day 90); OLE arms: From OLE baseline (Day 1 of OLE) up to 24 months after start of OLE (the actual OLE starting time varied for each participant) DB period: SAF included all randomized participants who received at least 1 dose of JNJ-40411813 or placebo in the DB period. OLE period: SAFOLE analysis set included all randomized participants who received at least 1 dose of study intervention in the OLE period.

Additional Information

Executive Medical Director Neuro

Janssen Research & Development, LLC

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation.
Publication restrictions are in place

Restriction type: OTHER